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Regimen Optimization Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02137239
Recruitment Status : Completed
First Posted : May 13, 2014
Results First Posted : June 22, 2021
Last Update Posted : June 22, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Kidney Transplantation
Interventions Drug: Thymoglobulin
Drug: Belatacept
Drug: mycophenolate mofetil(MMF)
Drug: Corticosteroids
Drug: Everolimus(EVL)
Drug: Tacrolimus(TAC)
Enrollment 58
Recruitment Details  
Pre-assignment Details 58 participants randomized and treated
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description BELA + EVL TAC + MMF
Period Title: Overall Study
Started 26 32
Completed 23 26
Not Completed 3 6
Reason Not Completed
Discontinued Study Treatment             0             3
Withdrew Consent             1             1
Adverse Event             2             2
Arm/Group Title Treatment A Treatment B Total
Hide Arm/Group Description BELA + EVL TAC + MMF Total of all reporting groups
Overall Number of Baseline Participants 26 32 58
Hide Baseline Analysis Population Description
Randomized, Transplanted and Treated Population (ITT)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 32 participants 58 participants
51.7  (12.8) 50.8  (10.9) 51.2  (11.7)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 32 participants 58 participants
< 65
22
  84.6%
28
  87.5%
50
  86.2%
≥ 65
4
  15.4%
4
  12.5%
8
  13.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 32 participants 58 participants
Female
5
  19.2%
9
  28.1%
14
  24.1%
Male
21
  80.8%
23
  71.9%
44
  75.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 32 participants 58 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
3
   9.4%
3
   5.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  11.5%
6
  18.8%
9
  15.5%
White
23
  88.5%
21
  65.6%
44
  75.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
2
   6.3%
2
   3.4%
1.Primary Outcome
Title Percentage of Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6 Months
Hide Description Number of Participants with Clinically-suspected biopsy-proven acute rejection (CSBPAR) at 6 Months
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
BELA + EVL
TAC + MMF
Overall Number of Participants Analyzed 26 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
7.7
(0.9 to 25.1)
9.4
(2.0 to 25.0)
2.Secondary Outcome
Title Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6, 12 and 24 Months
Hide Description

Clinically-suspected biopsy-proven acute rejection (CSBPAR) at 6, 12 and 24 Months

Change in the incidence of CSBPAR at 6, 12 and 24 months post transplant, in the belatacept + EVL(Treatment A) as compared to TAC + MMF (Treatment B).

Time Frame Up to 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
BELA + EVL
TAC + MMF
Overall Number of Participants Analyzed 26 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of CSBPAR
CSBPAR at 6 Months
7.7
(0.9 to 25.1)
9.4
(2.0 to 25.0)
CSBPAR at 12 months
11.5
(2.4 to 30.2)
12.5
(3.5 to 29.0)
CSBPAR at 24 Months
15.4
(4.4 to 34.9)
12.5
(3.5 to 29.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment A, Treatment B
Comments Change in Incidence of Treatment A as compared to Treatment B at 6 Months
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence of Change
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-18.9 to 16.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Treatment A, Treatment B
Comments Change in Incidence of Treatment A as compared to Treatment B at 12 Months
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence of Change
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-19.2 to 18.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Treatment A, Treatment B
Comments Change in Incidence of Treatment A as compared to Treatment B at 24 Months
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence of Change
Estimated Value 2.9
Confidence Interval (2-Sided) 95%
-16.1 to 23.9
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time to Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR).
Hide Description Time to Clinically suspected biopsy proven acute rejection
Time Frame Up to 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a CSBPAR
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
BELA + EVL
TAC + MMF
Overall Number of Participants Analyzed 3 3
Mean (Full Range)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Randomization Error: See limitations and caveats
4.Secondary Outcome
Title Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection
Hide Description

Treatment differences in the severity grades to treat all episodes of CSBPAR at 6, 12, and 24 months post-transplant.

Type 1A - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/Tubular cross section or group of 10 Tubular cell). Type 1B - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>10 mononuclear cells/Tubular cross section or group of 10 Tubular cell).Type 2A - Cases with mild to moderate intimal arteritis.Type 2B - Cases with severe intimal arteritis comprising >25% of the luminal area. Type 3 - Cases with "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (v3 with accompanying lymphocytic inflammation)

Time Frame At 6, 12 and 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
BELA + EVL
TAC + MMF
Overall Number of Participants Analyzed 26 32
Measure Type: Number
Unit of Measure: Percentage of Participants
6 Months: Mild Acute (1A) 3.8 0
6 Months: Mild Acute (1B) 0 3.1
6 Months: Moderate Acute (2A) 7.7 6.3
6 Months: Moderate Acute (2B) 0 0
6 Months: Severe Acute 0 0
12 Months: Mild Acute (1A) 7.7 3.1
12 Months: Mild Acute (1B) 0 3.1
12 Months: Moderate Acute (2A) 7.7 6.3
12 Months: Moderate Acute (2B) 0 0
12 Months: Severe Acute 0 0
24 Months: Mild Acute (1A) 11.5 3.1
24 Months: Mild Acute (1B) 0 3.1
24 Months: Moderate Acute (2A) 7.7 6.3
24 Months: Moderate Acute (2B) 0 0
24 Months: Severe Acute 0 0
5.Secondary Outcome
Title Treatment Differences in Therapeutic Modalities
Hide Description Treatment Received for Biopsy Proven Acute Rejection (Banff Grade IA or Higher), or Humoral (Antibody Mediated) Rejection Treatment regimen: Categorical analysis of CSBPAR episodes by treatment received.
Time Frame at 6, 12 and 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized, Transplanted and Treated Participants
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
BELA + EVL
TAC + MMF
Overall Number of Participants Analyzed 26 32
Measure Type: Number
Unit of Measure: Percentage of participants with CSBPARs
Corticosteroids (6 months) 7.7 9.4
Lymphocyte depleting agent (6 months) 0 6.3
Plasmapheresis (6 months) 0 0
IVIG (6 months) 0 3.1
Rituximab (6 months) 0 0
Corticosteroids (12 months) 15.4 12.5
Lymphocyte depleting agent (12 months) 3.8 6.3
Plasmapheresis (12 months) 0 0
IVIG (12 months) 0 3.1
Rituximab (12 months) 0 0
Corticosteroids (24 months) 19.2 12.5
Lymphocyte depleting agent (24 months) 3.8 6.3
Plasmapheresis (24 months) 0 0
IVIG (24 months) 0 3.1
Rituximab (24 months) 0 0
6.Secondary Outcome
Title Number of Participants Who Survive With a Functioning Graft
Hide Description Number of all participants who survive with a functioning graft at 6, 12 and 24 months post transplant
Time Frame At 6, 12 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Participants
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
BELA + EVL
TAC + MMF
Overall Number of Participants Analyzed 26 32
Measure Type: Count of Participants
Unit of Measure: Participants
At 6 Months
25
  96.2%
31
  96.9%
At 12 Months
25
  96.2%
31
  96.9%
At 24 Months
25
  96.2%
31
  96.9%
7.Secondary Outcome
Title Number of Participants Deaths Post Transplant
Hide Description Number of participant deaths at 6, 12 and 24 months post transplant
Time Frame up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Participants
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
BELA + EVL
TAC + MMF
Overall Number of Participants Analyzed 26 32
Measure Type: Count of Participants
Unit of Measure: Participants
At 6 Months
0
   0.0%
0
   0.0%
At 12 Months
0
   0.0%
0
   0.0%
At 24 Months
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Number of Participants Who Experience Graft Loss Post Transplant
Hide Description Number of all participants who experience graft loss at 6, 12 and 24 months post transplant
Time Frame At 6, 12 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
BELA + EVL
TAC + MMF
Overall Number of Participants Analyzed 26 32
Measure Type: Count of Participants
Unit of Measure: Participants
At 6 Months
1
   3.8%
1
   3.1%
At 12 Months
1
   3.8%
1
   3.1%
At 24 Months
1
   3.8%
1
   3.1%
9.Secondary Outcome
Title Time to Event: Graft Loss and Death
Hide Description The Number of days to participant Graft Loss and death for any reason
Time Frame Up to 728 Days
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Participants
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
BELA + EVL
TAC + MMF
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: Days
Graft Loss Number Analyzed 1 participants 1 participants
107 2
Death Number Analyzed 0 participants 0 participants
10.Secondary Outcome
Title Absolute Calculated Glomerular Filtration Rate (cGFR): Mean
Hide Description Absolute (mean and median) cGFR values at 3, 6, 12 and 24 months post-transplant, as determined from the 4-variable Modification of Diet in Renal Disease (MDRD) formula
Time Frame Up 24 Months post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
BELA + EVL
TAC + MMF
Overall Number of Participants Analyzed 26 32
Mean (95% Confidence Interval)
Unit of Measure: mL/min/1.73 m^2
At 3 Months Number Analyzed 25 participants 31 participants
69.2
(60.2 to 78.3)
62.2
(55.3 to 69.1)
At 6 Months Number Analyzed 25 participants 31 participants
66.0
(55.8 to 76.2)
63.9
(56.2 to 71.5)
At 12 Months Number Analyzed 25 participants 31 participants
66.2
(56.9 to 75.4)
62.0
(53.4 to 70.6)
At 24 Months Number Analyzed 24 participants 25 participants
71.8
(62.5 to 81.0)
68.7
(59.2 to 78.2)
11.Secondary Outcome
Title Median Calculated Glomerular Filtration Rate (cGFR)
Hide Description Median cGFR values at 3, 6, 12 and 24 months post-transplant, as determined from the 4-variable Modification of Diet in Renal Disease (MDRD) formula
Time Frame Up 24 Months post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
BELA + EVL
TAC + MMF
Overall Number of Participants Analyzed 26 32
Median (Full Range)
Unit of Measure: mL/min/1.73 m^2
At 3 Months Number Analyzed 25 participants 31 participants
64.0
(52.0 to 80.0)
62.0
(55.0 to 79.0)
At 6 Months Number Analyzed 25 participants 31 participants
64.0
(56.0 to 79.0)
67.0
(55.0 to 75.0)
At 12 Months Number Analyzed 25 participants 31 participants
66.0
(58.0 to 77.0)
62.5
(47.5 to 74.0)
At 24 Months Number Analyzed 24 participants 25 participants
73.5
(59.5 to 84.5)
68.0
(56.0 to 82.0)
12.Secondary Outcome
Title Mean Change From Month 3 in cGFR
Hide Description The mean change from Month 3 cGFR at 3, 6, 12 and 24 months post-transplant
Time Frame Up 24 Months post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
BELA + EVL
TAC + MMF
Overall Number of Participants Analyzed 26 32
Mean (95% Confidence Interval)
Unit of Measure: mL/min/1.73 m^2
At 3 Months Number Analyzed 25 participants 31 participants
0
(0 to 0)
0
(0 to 0)
At 6 Months Number Analyzed 25 participants 31 participants
-3.2
(-10.9 to 4.5)
2.8
(-0.2 to 5.8)
At 12 Months Number Analyzed 25 participants 31 participants
-3.1
(-12.6 to 6.5)
1.4
(-3.3 to 6.0)
At 24 Months Number Analyzed 24 participants 25 participants
3.1
(-4.2 to 10.4)
6.3
(-0.6 to 13.2)
13.Secondary Outcome
Title Urine Protein Creatinine Ratio (UPr/Cr)
Hide Description Urine protein to creatinine ratio (UPr/Cr) at 3, 6, 12 and 24 months post-transplant.
Time Frame Up 24 Months post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
BELA + EVL
TAC + MMF
Overall Number of Participants Analyzed 26 32
Mean (95% Confidence Interval)
Unit of Measure: mg Protein/mg Creatinine
At 3 Months Number Analyzed 25 participants 27 participants
0.3146
(0.1985 to 0.4307)
0.1412
(0.1097 to 0.1726)
At 6 Months Number Analyzed 25 participants 27 participants
0.3896
(0.2326 to 0.5466)
0.1461
(0.1203 to 0.1720)
At 12 Months Number Analyzed 23 participants 24 participants
0.2835
(0.1648 to 0.4021)
0.1849
(0.1041 to 0.2658)
At 24 Months Number Analyzed 20 participants 23 participants
0.3940
(0.2199 to 0.5680)
0.1685
(0.1174 to 0.2195)
14.Secondary Outcome
Title Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA)
Hide Description Percentage of participants with, and titers of pre-existing (pre-transplant) DSA on Day 1 (pre-transplant, pre-dose), and at Months 12 and 24 posttransplant
Time Frame Up to 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
As Treated Population
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
BELA + EVL
TAC + MMF
Overall Number of Participants Analyzed 25 33
Measure Type: Number
Unit of Measure: Percentage of Participants
Baseline Class 1 DSA Number Analyzed 20 participants 29 participants
10 0
Baseline Class 2 DSA Number Analyzed 20 participants 29 participants
0 0
Baseline Both Class 1 and 2 DSA Number Analyzed 20 participants 29 participants
0 0
12 Month Class 1 DSA Number Analyzed 25 participants 33 participants
8.00 0
12 Month Class 2 DSA Number Analyzed 25 participants 33 participants
0 3.03
12 Month Both Class 1 and 2 DSA Number Analyzed 25 participants 33 participants
0 0
24 Month Class 1 DSA Number Analyzed 25 participants 33 participants
8.00 3.03
24 Month Class 2 DSA Number Analyzed 25 participants 33 participants
0 3.03
24 Month Both Class 1 and 2 DSA Number Analyzed 25 participants 33 participants
0 0
15.Secondary Outcome
Title Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA)
Hide Description Characterization of any de novo DSA detected by IgM and IgG subclasses, and by the presence or absence of complement fixing properties.
Time Frame Up to 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
As Treated Population
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
BELA + EVL
TAC + MMF
Overall Number of Participants Analyzed 25 33
Measure Type: Number
Unit of Measure: Percentage
Baseline Class 1 DSA Number Analyzed 20 participants 29 participants
10 0
Baseline Class 2 DSA Number Analyzed 20 participants 29 participants
0 0
Baseline Both Class 1 and 2 DSA Number Analyzed 20 participants 29 participants
0 0
De Novo 12 Month Class 1 DSA Number Analyzed 25 participants 29 participants
0 0
De Novo 12 Month Class 2 DSA Number Analyzed 25 participants 29 participants
0 0
De Novo 12 Month Both Class 1 and 2 DSA Number Analyzed 25 participants 29 participants
0 0
De Novo 24 Month Class 1 DSA Number Analyzed 20 participants 29 participants
0 3.45
De Novo 24 Month Class 2 DSA Number Analyzed 20 participants 29 participants
0 0
De Novo 24 Month Both Class 1 and 2 DSA Number Analyzed 20 participants 29 participants
0 0
16.Secondary Outcome
Title Percentage of Participants With Adverse Events (AEs)
Hide Description Percentage of participants with AEs up to 24 months post-transplant
Time Frame Up to 24 months Post-Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
As Treated Population
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
BELA + EVL
TAC + MMF
Overall Number of Participants Analyzed 25 33
Measure Type: Number
Unit of Measure: Percentage of participants with AEs
100.0 97.0
17.Secondary Outcome
Title Percentage of Participants With Serious Adverse Events (SAEs)
Hide Description Percentage of participants with SAEs up to 24 months post-transplant
Time Frame Up to 24 months Post-Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
As Treated Population
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
BELA + EVL
TAC + MMF
Overall Number of Participants Analyzed 25 33
Measure Type: Number
Unit of Measure: Percentage of participants with SAEs
52.0 60.6
18.Secondary Outcome
Title Percentage of Participants With Events of Special Interest (ESIs)
Hide Description

Percentage of participants which have one of the following events of special interest:

Serious Infections Post-Transplant Lymphoproliferative Disorder (PTLD) Progressive multifocal leukoencephalopathy (PML) Malignancies (Other than PTLD) including non-melanoma skin carcinomas (Malignancies) Tuberculosis Infections Central Nervous System (CNS) Infections Viral Infections Infusion Related reactions within 24 hours since belatacept infusion

Time Frame Up to 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
As Treated Population
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
BELA + EVL
TAC + MMF
Overall Number of Participants Analyzed 25 33
Measure Type: Number
Unit of Measure: Percentage of participants with ESIs
Serious Infections 16 15.2
PTLD 4.0 3.0
PML 0 0
Malignancies 4.0 3.0
TB 0 0
CNS Infections 0 0
Viral Infections 0 0
Infusion Related Reactions 1 0
19.Secondary Outcome
Title Percentage of Particpants With Laboratory Test Abnormalities (LTAs)
Hide Description Percentage of participants with laboratory tests with marked laboratory abnormalities
Time Frame At 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
As Treated Population
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
BELA + EVL
TAC + MMF
Overall Number of Participants Analyzed 25 33
Measure Type: Number
Unit of Measure: Percentage of participants
Hemoglobin (Low) 12.0 6.1
Leukocytes (low) 0 3
Lymphocyte (Absolute) (low) 84.0 69.7
Neutrophils (Absolute) (low) 0 3
Aspartate Aminotransferase (High) 4.0 0
Creatinine (High) 16.0 3.0
Inorganic Phosphorus (low) 24.0 12.1
Potassium (high) 4.0 0
Sodium (low) 4.0 0
Albumin (low) 0 3
Glucose (high) 8.0 12.1
Triglycerides (high) 12.0 0
Uric Acid (high) 8.0 0
20.Secondary Outcome
Title Mean and Mean Change From Baseline in Blood Glucose
Hide Description Mean fasting blood glucose levels, and mean changes from baseline values at Months 6, 12 and 24 months post- transplant
Time Frame Up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
BELA + EVL
TAC + MMF
Overall Number of Participants Analyzed 26 32
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
Mean Value at 6 months Number Analyzed 20 participants 25 participants
107.2
(86.6 to 127.8)
107.2
(93.8 to 120.7)
Change from baseline at 6 months Number Analyzed 18 participants 20 participants
4.9
(-5.8 to 15.7)
4.8
(-17.6 to 27.2)
Mean Value at 12 months Number Analyzed 23 participants 24 participants
101.1
(85.3 to 117.0)
127.5
(99.2 to 155.8)
Change from baseline at 12 months Number Analyzed 20 participants 18 participants
-1.3
(-24.7 to 22.1)
20.6
(0.4 to 40.8)
Mean Value at 24 months Number Analyzed 17 participants 19 participants
127.5
(93.7 to 161.4)
111.8
(87.1 to 136.5)
Change from baseline at 24 months Number Analyzed 14 participants 14 participants
22.3
(-15.7 to 60.3)
15.0
(-3.2 to 33.2)
21.Secondary Outcome
Title Mean and Mean Change From Baseline in Whole Blood HbA1c
Hide Description Mean whole blood HbA1C concentrations, and mean changes from baseline values at Months 6, 12 and 24 months post-transplant.
Time Frame Up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
BELA + EVL
TAC + MMF
Overall Number of Participants Analyzed 26 32
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
Mean Value at 6 months Number Analyzed 22 participants 26 participants
6.11
(5.47 to 6.75)
6.13
(5.44 to 6.82)
Change from baseline at 6 months Number Analyzed 22 participants 25 participants
0.34
(0.06 to 0.62)
0.48
(0.04 to 0.91)
Mean Value at 12 months Number Analyzed 24 participants 24 participants
6.18
(5.42 to 6.93)
6.21
(5.50 to 6.92)
Change from baseline at 12 months Number Analyzed 23 participants 23 participants
0.47
(-0.00 to 0.95)
0.32
(-0.17 to 0.81)
Mean Value at 24 months Number Analyzed 19 participants 22 participants
6.24
(5.27 to 7.20)
6.29
(5.38 to 7.20)
Change from baseline at 24 months Number Analyzed 18 participants 21 participants
0.66
(-0.05 to 1.37)
0.41
(-0.13 to 0.95)
22.Secondary Outcome
Title Percentage of Participants With New Onset Diabetes After Transplant
Hide Description Percentage of participants with New Onset Diabetes After Transplantation (NODAT) at 6, 12, and 24 months post-transplant.
Time Frame up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
BELA + EVL
TAC + MMF
Overall Number of Participants Analyzed 26 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Up to 6 Months
11.5
(2.4 to 30.2)
6.3
(0.8 to 20.8)
Up to 12 Months
11.5
(2.4 to 30.2)
6.3
(0.8 to 20.8)
Up to 24 Months
15.4
(4.4 to 34.9)
12.5
(3.5 to 29.0)
23.Secondary Outcome
Title Absolute Values of Blood Pressure: Mean
Hide Description Absolute (mean and median) values for SBP and DBP at 3, 6, 12 and 24 months posttransplant;
Time Frame Up to 24 Months
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ITT Population
Arm/Group Title Treatment A Treatment B
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BELA + EVL
TAC + MMF
Overall Number of Participants Analyzed 26 32
Mean (95% Confidence Interval)
Unit of Measure: mmHg
Diastolic Month 3 Number Analyzed 26 participants 30 participants
78.7
(74.2 to 83.2)
77.7
(74.0 to 81.3)
Systolic Month 3 Number Analyzed 26 participants 30 participants
134.2
(126.9 to 141.6)
131.0
(124.9 to 137.0)
Diastolic Month 6 Number Analyzed 24 participants 28 participants
77.4
(73.6 to 81.3)
79.4
(76.0 to 82.9)
Systolic Month 6 Number Analyzed 24 participants 28 participants
128.1
(121.8 to 134.5)
133.0
(127.2 to 138.8)
Diastolic Month 12 Number Analyzed 24 participants 27 participants
78.7
(74.6 to 82.9)
80.1
(76.4 to 83.8)
Systolic Month 12 Number Analyzed 24 participants 27 participants
131.0
(125.6 to 136.4)
131.0
(123.4 to 138.7)
Diastolic Month 24 Number Analyzed 23 participants 24 participants
78.1
(74.2 to 81.9)
78.5
(74.3 to 82.8)
Systolic Month 24 Number Analyzed 23 participants 24 participants
130.9
(125.2 to 136.5)
131.7
(125.2 to 138.2)
24.Secondary Outcome
Title Absolute Values of Blood Pressure: Median
Hide Description Absolute (mean and median) values for SBP and DBP at 3, 6, 12 and 24 months posttransplant;
Time Frame Up to 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
BELA + EVL
TAC + MMF
Overall Number of Participants Analyzed 26 32
Median (Full Range)
Unit of Measure: mmHg
Diastolic Month 3 Number Analyzed 26 participants 30 participants
78.5
(70.0 to 88.0)
80.0
(70.0 to 84.0)
Systolic Month 3 Number Analyzed 26 participants 30 participants
135.5
(127.0 to 144.0)
131.0
(122.0 to 138.0)
Diastolic Month 6 Number Analyzed 24 participants 28 participants
75.5
(70.5 to 83.0)
80.0
(71.0 to 85.5)
Systolic Month 6 Number Analyzed 24 participants 28 participants
127.0
(114.5 to 136.5)
131.0
(124.0 to 142.5)
Diastolic Month 12 Number Analyzed 24 participants 27 participants
77.0
(71.5 to 86.0)
81.0
(72.0 to 88.0)
Systolic Month 12 Number Analyzed 24 participants 27 participants
130.0
(119.0 to 142.0)
126.0
(115.0 to 146.0)
Diastolic Month 24 Number Analyzed 23 participants 24 participants
78.0
(71.0 to 86.0)
79.0
(69.5 to 85.0)
Systolic Month 24 Number Analyzed 23 participants 24 participants
130.0
(122.0 to 142.0)
130.0
(121.5 to 139.0)
25.Secondary Outcome
Title Mean Changes From Baseline Values for Blood Pressure
Hide Description Mean changes from baseline values for SBP and DBP at 6, 12 and 24 months post-transplant
Time Frame Up to 24 Months
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Hide Analysis Population Description
ITT Population
Arm/Group Title Treatment A Treatment B
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BELA + EVL
TAC + MMF
Overall Number of Participants Analyzed 26 32
Mean (95% Confidence Interval)
Unit of Measure: mmHg
Diastolic Month 6 Number Analyzed 24 participants 28 participants
1.0
(-4.7 to 6.7)
4.8
(-1.2 to 10.8)
Systolic Month 6 Number Analyzed 24 participants 28 participants
-4.0
(-13.9 to 5.9)
-0.7
(-10.0 to 8.7)
Diastolic Month 12 Number Analyzed 24 participants 27 participants
2.3
(-4.0 to 8.6)
5.4
(-1.0 to 11.7)
Systolic Month 12 Number Analyzed 24 participants 27 participants
-1.1
(-9.6 to 7.4)
-3.2
(-14.7 to 8.3)
Diastolic Month 24 Number Analyzed 23 participants 24 participants
0.9
(-5.5 to 7.3)
2.1
(-3.9 to 8.1)
Systolic Month 24 Number Analyzed 23 participants 24 participants
-2.3
(-12.2 to 7.6)
-4.2
(-14.4 to 6.0)
26.Secondary Outcome
Title Absolute Values of Fasting Lipid Values: Mean
Hide Description

Absolute (mean and median) values at 3, 6, 12 and 24 months post-transplant for the following:

Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG)

Time Frame Up to 24 Months
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Hide Analysis Population Description
ITT Population
Arm/Group Title Treatment A Treatment B
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BELA + EVL
TAC + MMF
Overall Number of Participants Analyzed 26 32
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
TC Month 3 Number Analyzed 18 participants 23 participants
181.2
(157.8 to 204.7)
174.4
(154.8 to 194.1)
TC Month 6 Number Analyzed 20 participants 25 participants
197.7
(177.9 to 217.4)
175
(158.8 to 191.6)
TC Month 12 Number Analyzed 23 participants 24 participants
189.0
(171.7 to 206.3)
169.9
(153.8 to 186.0)
TC Month 24 Number Analyzed 17 participants 19 participants
193.2
(172.1 to 214.2)
168.2
(152.9 to 183.4)
HDL Month 3 Number Analyzed 18 participants 23 participants
50.6
(43.5 to 57.6)
50.4
(43.9 to 56.9)
HDL Month 6 Number Analyzed 20 participants 25 participants
46.4
(41.3 to 51.5)
53.9
(45.9 to 61.8)
HDL Month 12 Number Analyzed 22 participants 24 participants
49.4
(44.0 to 54.8)
49.6
(42.5 to 56.6)
HDL Month 24 Number Analyzed 17 participants 19 participants
50.1
(44.7 to 55.5)
51.3
(43.0 to 59.6)
LDL Month 3 Number Analyzed 17 participants 23 participants
96.9
(77.9 to 115.9)
96.5
(80.3 to 112.6)
LDL Month 6 Number Analyzed 20 participants 25 participants
115.2
(98.1 to 132.3)
93.7
(79.2 to 108.2)
LDL Month 12 Number Analyzed 22 participants 24 participants
107.5
(92.8 to 122.2)
88.0
(74.3 to 101.8)
LDL Month 24 Number Analyzed 14 participants 18 participants
97.9
(81.6 to 114.2)
91.5
(75.4 to 107.6)
TG Month 3 Number Analyzed 18 participants 23 participants
171.6
(118.1 to 225.0)
137.8
(106.6 to 168.9)
TG Month 6 Number Analyzed 20 participants 25 participants
180.0
(140.2 to 219.7)
138.3
(108.0 to 168.5)
TG Month 12 Number Analyzed 23 participants 24 participants
162.4
(132.2 to 192.6)
161.3
(126.4 to 196.1)
TG Month 24 Number Analyzed 17 participants 19 participants
263.4
(131.2 to 395.5)
145.0
(99.8 to 190.2)
27.Secondary Outcome
Title Absolute Values of Fasting Lipid Values: Median
Hide Description

Absolute (mean and median) values at 3, 6, 12 and 24 months post-transplant for the following:

Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG)

Time Frame Up to 24 Months
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Hide Analysis Population Description
ITT Population
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
BELA + EVL
TAC + MMF
Overall Number of Participants Analyzed 26 32
Median (Full Range)
Unit of Measure: mg/dL
TC Month 3 Number Analyzed 18 participants 23 participants
167.0
(160.0 to 213.0)
173.0
(146.0 to 197.0)
TC Month 6 Number Analyzed 20 participants 25 participants
187.0
(170.5 to 226.5)
178.0
(146.0 to 199.0)
TC Month 12 Number Analyzed 23 participants 24 participants
184.0
(166.0 to 213.0)
171.5
(146.5 to 193.5)
TC Month 24 Number Analyzed 17 participants 19 participants
193.0
(166.0 to 206.0)
166.0
(137.0 to 201.0)
HDL Month 3 Number Analyzed 18 participants 23 participants
45.0
(39.0 to 62.0)
49.0
(38.0 to 63.0)
HDL Month 6 Number Analyzed 20 participants 25 participants
45.5
(39.0 to 51.0)
49.0
(37.0 to 68.0)
HDL Month 12 Number Analyzed 22 participants 24 participants
50.0
(40.0 to 58.0)
47.0
(37.0 to 61.0)
HDL Month 24 Number Analyzed 17 participants 19 participants
49.0
(43.0 to 58.0)
49.0
(35.0 to 71.0)
LDL Month 3 Number Analyzed 17 participants 23 participants
89.0
(74.0 to 127.0)
95.0
(75.0 to 116.0)
LDL Month 6 Number Analyzed 20 participants 25 participants
99.5
(85.5 to 143.0)
100.0
(66.0 to 115.0)
LDL Month 12 Number Analyzed 22 participants 24 participants
104.0
(85.0 to 128.0)
91.5
(65.0 to 109.0)
LDL Month 24 Number Analyzed 14 participants 18 participants
103.5
(74.0 to 121.0)
86.0
(70.0 to 119.0)
TG Month 3 Number Analyzed 18 participants 23 participants
147.0
(107.0 to 195.0)
128.0
(81.0 to 174.0)
TG Month 6 Number Analyzed 20 participants 25 participants
157.5
(113.5 to 245.5)
126.0
(85.0 to 194.0)
TG Month 12 Number Analyzed 23 participants 24 participants
154.0
(100.0 to 230.0)
130.0
(106.0 to 202.0)
TG Month 24 Number Analyzed 17 participants 19 participants
159.0
(137.0 to 284.0)
114.0
(80.0 to 174.0)
28.Secondary Outcome
Title Mean Changes From Baseline Values of Lipid Values
Hide Description

Mean changes from baseline values in the following:

Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG)

Time Frame at months 12 and 24
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ITT Population
Arm/Group Title Treatment A Treatment B
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BELA + EVL
TAC + MMF
Overall Number of Participants Analyzed 26 32
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
TC Month 12 Number Analyzed 22 participants 22 participants
25.7
(3.5 to 47.9)
-2.8
(-41.5 to 35.8)
TC Month 24 Number Analyzed 16 participants 17 participants
26.6
(4.0 to 49.1)
10.0
(-9.9 to 29.9)
HDL Month 12 Number Analyzed 21 participants 22 participants
5.4
(-0.3 to 11.0)
1.9
(-3.7 to 7.5)
HDL Month 24 Number Analyzed 16 participants 17 participants
6.2
(0.7 to 11.6)
4.8
(-2.2 to 11.9)
LDL Month 12 Number Analyzed 20 participants 16 participants
25.7
(7.9 to 43.4)
10.8
(-10.8 to 32.4)
LDL Month 24 Number Analyzed 11 participants 12 participants
17.4
(0.0 to 34.7)
15.7
(-4.4 to 35.7)
TG Month 12 Number Analyzed 20 participants 18 participants
3.3
(-26.0 to 32.5)
-86.1
(-288.9 to 116.7)
TG Month 24 Number Analyzed 14 participants 14 participants
106.8
(-32.6 to 246.2)
-13.6
(-73.8 to 46.5)
Time Frame Up to 24 months after last treatment dose
Adverse Event Reporting Description Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
 
Arm/Group Title BELA+EVL TAC+MMF
Hide Arm/Group Description BELA + EVL TAC + MMF
All-Cause Mortality
BELA+EVL TAC+MMF
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/33 (0.00%) 
Hide Serious Adverse Events
BELA+EVL TAC+MMF
Affected / at Risk (%) Affected / at Risk (%)
Total   13/25 (52.00%)   20/33 (60.61%) 
Blood and lymphatic system disorders     
Anaemia  1  1/25 (4.00%)  1/33 (3.03%) 
Febrile neutropenia  1  0/25 (0.00%)  2/33 (6.06%) 
Neutropenia  1  0/25 (0.00%)  4/33 (12.12%) 
Pancytopenia  1  1/25 (4.00%)  0/33 (0.00%) 
Cardiac disorders     
Arteriospasm coronary  1  0/25 (0.00%)  1/33 (3.03%) 
Atrial fibrillation  1  1/25 (4.00%)  1/33 (3.03%) 
Gastrointestinal disorders     
Abdominal adhesions  1  0/25 (0.00%)  1/33 (3.03%) 
Ascites  1  1/25 (4.00%)  0/33 (0.00%) 
Diarrhoea  1  1/25 (4.00%)  0/33 (0.00%) 
Duodenal ulcer  1  0/25 (0.00%)  1/33 (3.03%) 
Gastritis erosive  1  0/25 (0.00%)  1/33 (3.03%) 
Incarcerated inguinal hernia  1  1/25 (4.00%)  0/33 (0.00%) 
Intra-abdominal fluid collection  1  1/25 (4.00%)  0/33 (0.00%) 
Intra-abdominal haematoma  1  1/25 (4.00%)  0/33 (0.00%) 
Retroperitoneal haemorrhage  1  1/25 (4.00%)  0/33 (0.00%) 
Small intestinal obstruction  1  0/25 (0.00%)  1/33 (3.03%) 
Vomiting  1  1/25 (4.00%)  0/33 (0.00%) 
Hepatobiliary disorders     
Cholecystitis acute  1  2/25 (8.00%)  0/33 (0.00%) 
Immune system disorders     
Renal transplant failure  1  0/25 (0.00%)  1/33 (3.03%) 
Infections and infestations     
Cellulitis  1  1/25 (4.00%)  0/33 (0.00%) 
Gastroenteritis  1  0/25 (0.00%)  1/33 (3.03%) 
Gastroenteritis norovirus  1  0/25 (0.00%)  1/33 (3.03%) 
Herpes zoster  1  0/25 (0.00%)  1/33 (3.03%) 
Osteomyelitis  1  0/25 (0.00%)  1/33 (3.03%) 
Osteomyelitis acute  1  0/25 (0.00%)  1/33 (3.03%) 
Pneumonia  1  1/25 (4.00%)  0/33 (0.00%) 
Renal graft infection  1  1/25 (4.00%)  0/33 (0.00%) 
Septic shock  1  0/25 (0.00%)  1/33 (3.03%) 
Urinary tract infection  1  3/25 (12.00%)  0/33 (0.00%) 
Injury, poisoning and procedural complications     
Overdose  1  0/25 (0.00%)  1/33 (3.03%) 
Vascular pseudoaneurysm  1  1/25 (4.00%)  0/33 (0.00%) 
Investigations     
Blood creatinine increased  1  1/25 (4.00%)  3/33 (9.09%) 
Weight decreased  1  1/25 (4.00%)  0/33 (0.00%) 
Metabolism and nutrition disorders     
Diabetes mellitus  1  0/25 (0.00%)  1/33 (3.03%) 
Hyponatraemia  1  0/25 (0.00%)  1/33 (3.03%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Plasma cell myeloma  1  0/25 (0.00%)  1/33 (3.03%) 
Post transplant lymphoproliferative disorder  1  1/25 (4.00%)  1/33 (3.03%) 
Nervous system disorders     
Central nervous system vasculitis  1  0/25 (0.00%)  1/33 (3.03%) 
Cerebellar ataxia  1  1/25 (4.00%)  0/33 (0.00%) 
Haemorrhage intracranial  1  0/25 (0.00%)  1/33 (3.03%) 
Renal and urinary disorders     
Acute kidney injury  1  0/25 (0.00%)  2/33 (6.06%) 
Bladder stenosis  1  1/25 (4.00%)  0/33 (0.00%) 
Haematuria  1  0/25 (0.00%)  1/33 (3.03%) 
Hydronephrosis  1  0/25 (0.00%)  1/33 (3.03%) 
Nephropathy toxic  1  1/25 (4.00%)  0/33 (0.00%) 
Perinephric collection  1  1/25 (4.00%)  0/33 (0.00%) 
Proteinuria  1  0/25 (0.00%)  1/33 (3.03%) 
Renal artery stenosis  1  0/25 (0.00%)  1/33 (3.03%) 
Renal impairment  1  0/25 (0.00%)  1/33 (3.03%) 
Renal tubular necrosis  1  1/25 (4.00%)  1/33 (3.03%) 
Ureteral necrosis  1  1/25 (4.00%)  0/33 (0.00%) 
Skin and subcutaneous tissue disorders     
Diabetic foot  1  1/25 (4.00%)  0/33 (0.00%) 
Vascular disorders     
Dry gangrene  1  1/25 (4.00%)  0/33 (0.00%) 
Iliac artery occlusion  1  1/25 (4.00%)  0/33 (0.00%) 
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BELA+EVL TAC+MMF
Affected / at Risk (%) Affected / at Risk (%)
Total   25/25 (100.00%)   30/33 (90.91%) 
Blood and lymphatic system disorders     
Anaemia  1  4/25 (16.00%)  5/33 (15.15%) 
Leukocytosis  1  0/25 (0.00%)  2/33 (6.06%) 
Leukopenia  1  8/25 (32.00%)  7/33 (21.21%) 
Neutropenia  1  1/25 (4.00%)  2/33 (6.06%) 
Thrombocytopenia  1  0/25 (0.00%)  2/33 (6.06%) 
Cardiac disorders     
Atrial fibrillation  1  4/25 (16.00%)  1/33 (3.03%) 
Palpitations  1  2/25 (8.00%)  0/33 (0.00%) 
Tachycardia  1  2/25 (8.00%)  2/33 (6.06%) 
Gastrointestinal disorders     
Abdominal distension  1  0/25 (0.00%)  4/33 (12.12%) 
Abdominal pain  1  2/25 (8.00%)  3/33 (9.09%) 
Abdominal pain lower  1  1/25 (4.00%)  2/33 (6.06%) 
Abdominal pain upper  1  2/25 (8.00%)  1/33 (3.03%) 
Aphthous ulcer  1  4/25 (16.00%)  2/33 (6.06%) 
Constipation  1  5/25 (20.00%)  10/33 (30.30%) 
Diarrhoea  1  4/25 (16.00%)  10/33 (30.30%) 
Dyspepsia  1  0/25 (0.00%)  4/33 (12.12%) 
Flatulence  1  1/25 (4.00%)  2/33 (6.06%) 
Gastrooesophageal reflux disease  1  0/25 (0.00%)  5/33 (15.15%) 
Mouth ulceration  1  10/25 (40.00%)  0/33 (0.00%) 
Nausea  1  5/25 (20.00%)  13/33 (39.39%) 
Vomiting  1  5/25 (20.00%)  7/33 (21.21%) 
General disorders     
Chest pain  1  2/25 (8.00%)  0/33 (0.00%) 
Fatigue  1  4/25 (16.00%)  3/33 (9.09%) 
Oedema peripheral  1  5/25 (20.00%)  5/33 (15.15%) 
Pyrexia  1  2/25 (8.00%)  3/33 (9.09%) 
Infections and infestations     
BK virus infection  1  4/25 (16.00%)  3/33 (9.09%) 
Body tinea  1  2/25 (8.00%)  0/33 (0.00%) 
Bronchitis  1  2/25 (8.00%)  0/33 (0.00%) 
Cytomegalovirus viraemia  1  0/25 (0.00%)  2/33 (6.06%) 
Fungal infection  1  2/25 (8.00%)  0/33 (0.00%) 
Influenza  1  1/25 (4.00%)  3/33 (9.09%) 
Nasopharyngitis  1  1/25 (4.00%)  2/33 (6.06%) 
Onychomycosis  1  2/25 (8.00%)  0/33 (0.00%) 
Tooth infection  1  0/25 (0.00%)  2/33 (6.06%) 
Upper respiratory tract infection  1  2/25 (8.00%)  2/33 (6.06%) 
Urinary tract infection  1  5/25 (20.00%)  4/33 (12.12%) 
Injury, poisoning and procedural complications     
Complications of transplanted kidney  1  2/25 (8.00%)  1/33 (3.03%) 
Fall  1  1/25 (4.00%)  2/33 (6.06%) 
Graft complication  1  2/25 (8.00%)  0/33 (0.00%) 
Incision site pain  1  0/25 (0.00%)  3/33 (9.09%) 
Limb injury  1  0/25 (0.00%)  2/33 (6.06%) 
Procedural pain  1  4/25 (16.00%)  4/33 (12.12%) 
Wound  1  2/25 (8.00%)  0/33 (0.00%) 
Investigations     
Blood alkaline phosphatase increased  1  2/25 (8.00%)  0/33 (0.00%) 
Blood bicarbonate decreased  1  0/25 (0.00%)  2/33 (6.06%) 
Blood creatinine increased  1  1/25 (4.00%)  2/33 (6.06%) 
Donor specific antibody present  1  2/25 (8.00%)  0/33 (0.00%) 
Hepatic enzyme increased  1  2/25 (8.00%)  0/33 (0.00%) 
Lymphocyte count decreased  1  0/25 (0.00%)  2/33 (6.06%) 
White blood cell count decreased  1  3/25 (12.00%)  0/33 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  2/25 (8.00%)  2/33 (6.06%) 
Diabetes mellitus  1  2/25 (8.00%)  5/33 (15.15%) 
Fluid overload  1  3/25 (12.00%)  1/33 (3.03%) 
Hyperglycaemia  1  3/25 (12.00%)  5/33 (15.15%) 
Hyperkalaemia  1  1/25 (4.00%)  11/33 (33.33%) 
Hypocalcaemia  1  2/25 (8.00%)  3/33 (9.09%) 
Hypoglycaemia  1  0/25 (0.00%)  2/33 (6.06%) 
Hypokalaemia  1  7/25 (28.00%)  3/33 (9.09%) 
Hypomagnesaemia  1  2/25 (8.00%)  8/33 (24.24%) 
Hyponatraemia  1  0/25 (0.00%)  2/33 (6.06%) 
Hypophosphataemia  1  9/25 (36.00%)  8/33 (24.24%) 
Metabolic acidosis  1  4/25 (16.00%)  3/33 (9.09%) 
Vitamin D deficiency  1  0/25 (0.00%)  2/33 (6.06%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  6/25 (24.00%)  1/33 (3.03%) 
Back pain  1  1/25 (4.00%)  2/33 (6.06%) 
Flank pain  1  2/25 (8.00%)  0/33 (0.00%) 
Muscle spasms  1  0/25 (0.00%)  3/33 (9.09%) 
Myalgia  1  0/25 (0.00%)  2/33 (6.06%) 
Pain in extremity  1  1/25 (4.00%)  2/33 (6.06%) 
Nervous system disorders     
Dizziness  1  2/25 (8.00%)  4/33 (12.12%) 
Headache  1  5/25 (20.00%)  7/33 (21.21%) 
Hypoaesthesia  1  1/25 (4.00%)  3/33 (9.09%) 
Paraesthesia  1  0/25 (0.00%)  3/33 (9.09%) 
Tremor  1  0/25 (0.00%)  6/33 (18.18%) 
Psychiatric disorders     
Anxiety  1  2/25 (8.00%)  1/33 (3.03%) 
Insomnia  1  3/25 (12.00%)  5/33 (15.15%) 
Renal and urinary disorders     
Dysuria  1  3/25 (12.00%)  4/33 (12.12%) 
Haematuria  1  1/25 (4.00%)  5/33 (15.15%) 
Perinephric collection  1  0/25 (0.00%)  4/33 (12.12%) 
Proteinuria  1  4/25 (16.00%)  2/33 (6.06%) 
Renal impairment  1  1/25 (4.00%)  2/33 (6.06%) 
Renal tubular necrosis  1  1/25 (4.00%)  3/33 (9.09%) 
Urinary retention  1  1/25 (4.00%)  2/33 (6.06%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  2/25 (8.00%)  2/33 (6.06%) 
Dyspnoea  1  2/25 (8.00%)  2/33 (6.06%) 
Epistaxis  1  3/25 (12.00%)  0/33 (0.00%) 
Nasal congestion  1  2/25 (8.00%)  2/33 (6.06%) 
Oropharyngeal pain  1  1/25 (4.00%)  5/33 (15.15%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  0/25 (0.00%)  2/33 (6.06%) 
Seborrhoeic dermatitis  1  2/25 (8.00%)  0/33 (0.00%) 
Vascular disorders     
Hypertension  1  6/25 (24.00%)  8/33 (24.24%) 
Hypotension  1  0/25 (0.00%)  2/33 (6.06%) 
Orthostatic hypotension  1  2/25 (8.00%)  0/33 (0.00%) 
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
One participant with BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period. Due to this, time to CSBPAR was performed using this inaccurate population, therefore inaccurate data is not presented.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Phone: Please Email
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02137239    
Other Study ID Numbers: IM103-177
2013-002090-21 ( EudraCT Number )
First Submitted: May 12, 2014
First Posted: May 13, 2014
Results First Submitted: October 14, 2020
Results First Posted: June 22, 2021
Last Update Posted: June 22, 2021