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Belatacept Therapy for the Failing Renal Allograft (IM103-133)

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: NCT01921218
Recruitment Status : Completed
First Posted : August 13, 2013
Results First Posted : January 26, 2021
Last Update Posted : January 26, 2021
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Andrew B Adams, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Failing Renal Allograft
Interventions Drug: Belatacept
Drug: Calcineurin inhibitor therapy
Drug: Mycophenolate mofetil
Drug: prednisone
Enrollment 13
Recruitment Details Participants were enrolled at Emory University Hospital and the Emory Clinic in Atlanta, Georgia. Enrollment began August 2013 and all follow up was complete by December 12, 2019.
Pre-assignment Details  
Arm/Group Title Belatacept Treatment Group Control Group
Hide Arm/Group Description Participants with a failing kidney or failed kidney transplant receiving belatacept therapy Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression
Period Title: Overall Study
Started 6 7
Completed 3 3
Not Completed 3 4
Reason Not Completed
Death             2             1
Withdrawal by Subject             0             2
Kidney transplant             1             1
Arm/Group Title Belatacept Treatment Group Control Group Total
Hide Arm/Group Description Participants with a failing kidney or failed kidney transplant receiving belatacept therapy Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression Total of all reporting groups
Overall Number of Baseline Participants 6 7 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 7 participants 13 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  83.3%
7
 100.0%
12
  92.3%
>=65 years
1
  16.7%
0
   0.0%
1
   7.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 7 participants 13 participants
56.12  (9.12) 45.69  (14.99) 51.31  (12.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 7 participants 13 participants
Female
2
  33.3%
2
  28.6%
4
  30.8%
Male
4
  66.7%
5
  71.4%
9
  69.2%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 6 participants 7 participants 13 participants
6
 100.0%
7
 100.0%
13
 100.0%
1.Primary Outcome
Title Number of Participants With Donor-specific Antibody Formation
Hide Description The number of participants in each group with donor-specific antibody formation at 36 months following randomization.
Time Frame Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Belatacept Treatment Group Control Group
Hide Arm/Group Description:
Participants with a failing kidney or failed kidney transplant receiving belatacept therapy
Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression
Overall Number of Participants Analyzed 4 4
Measure Type: Count of Participants
Unit of Measure: Participants
3
  75.0%
4
 100.0%
2.Secondary Outcome
Title Glomerular Filtration Rate (GFR)
Hide Description The glomerular filtration rate (GFR) assesses kidney function. GFR uses values for serum creatinine (SCr) measured in mg/dL, age in years, blood urea nitrogen (BUN) measures in mg/dL, and serum albumin (Alb) measured in g/dL. GFR is calculated as 170 x (SCr/0.95)^(-0.999) x (Age)^(-0.176) x (0.762 if the patient is female) x (1.180 if the patient is black) x (BUN)^(-0.170) x (Alb)^(0.318). A value of 90 or above is considered normal while values between 15 and 29 indicate severely decreased kidney function and values below 15 indicate kidney failure. The GFR in participants who do not require dialysis will be followed for two years.
Time Frame Baseline up to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants requiring dialysis, either at the time of enrollment or initiating dialysis during the study, are not included in this analysis.
Arm/Group Title Belatacept Treatment Group Control Group
Hide Arm/Group Description:
Participants with a failing kidney or failed kidney transplant receiving belatacept therapy
Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression
Overall Number of Participants Analyzed 4 2
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73 m^2
Baseline Number Analyzed 4 participants 2 participants
14.25  (7.80) 14.5  (0.71)
Month 1 Number Analyzed 4 participants 2 participants
14.25  (8.06) 11  (1.41)
Month 2 Number Analyzed 3 participants 2 participants
19.33  (4.93) 10.5  (4.95)
Month 3 Number Analyzed 3 participants 2 participants
16.33  (1.53) 16.5  (4.95)
Month 6 Number Analyzed 3 participants 2 participants
14.67  (1.15) 14.5  (6.36)
Month 9 Number Analyzed 3 participants 2 participants
14.67  (3.06) 13.5  (10.61)
Month 12 Number Analyzed 3 participants 1 participants
13.67  (2.89) 20  (0)
Month 18 Number Analyzed 1 participants 0 participants
7  (0)
Month 24 Number Analyzed 0 participants 0 participants
3.Secondary Outcome
Title Time to Initiation of Dialysis
Hide Description Time to dialysis is measured as the time of randomization to initiation of dialysis. Participants already requiring dialysis at the time of enrollment were excluded from this endpoint analysis.
Time Frame Up to Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis includes participants who initiated dialysis during the course of the study.
Arm/Group Title Belatacept Treatment Group Control Group
Hide Arm/Group Description:
Participants with a failing kidney or failed kidney transplant receiving belatacept therapy
Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression
Overall Number of Participants Analyzed 4 2
Mean (Standard Deviation)
Unit of Measure: months
11.75  (7.46) 10.5  (2.12)
4.Secondary Outcome
Title Number of Participants With Anti-human Leukocyte Antigen (HLA) Alloantibodies
Hide Description The presence of anti-HLA Class I and Class II alloantibodies is categorized as being negative (absent for both classes of alloantibodies), positive for Class I, positive for Class II, and positive for both Class I and Class II alloantibodies.
Time Frame Baseline up to Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis includes participants remaining in the study at the indicated study visit.
Arm/Group Title Belatacept Treatment Group Control Group
Hide Arm/Group Description:
Participants with a failing kidney or failed kidney transplant receiving belatacept therapy
Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression
Overall Number of Participants Analyzed 6 7
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline - Negative Number Analyzed 6 participants 7 participants
6
 100.0%
5
  71.4%
Baseline - Positive Class I Number Analyzed 6 participants 7 participants
0
   0.0%
2
  28.6%
Baseline - Positive Class II Number Analyzed 6 participants 7 participants
0
   0.0%
0
   0.0%
Baseline - Positive Class I and II Number Analyzed 6 participants 7 participants
0
   0.0%
0
   0.0%
Month 12 - Negative Number Analyzed 5 participants 6 participants
4
  80.0%
2
  33.3%
Month 12 - Positive Class I Number Analyzed 5 participants 6 participants
1
  20.0%
4
  66.7%
Month 12 - Positive Class II Number Analyzed 5 participants 6 participants
0
   0.0%
3
  50.0%
Month 12 - Positive Class I and II Number Analyzed 5 participants 6 participants
0
   0.0%
3
  50.0%
Month 24 - Negative Number Analyzed 3 participants 3 participants
1
  33.3%
1
  33.3%
Month 24 - Positive Class I Number Analyzed 3 participants 3 participants
0
   0.0%
2
  66.7%
Month 24 - Positive Class II Number Analyzed 3 participants 3 participants
2
  66.7%
1
  33.3%
Month 24 - Positive Class I and II Number Analyzed 3 participants 3 participants
0
   0.0%
1
  33.3%
Month 36 - Negative Number Analyzed 3 participants 3 participants
1
  33.3%
1
  33.3%
Month 36 - Positive Class I Number Analyzed 3 participants 3 participants
0
   0.0%
2
  66.7%
Month 36 - Positive Class II Number Analyzed 3 participants 3 participants
2
  66.7%
1
  33.3%
Month 36 - Positive Class I and II Number Analyzed 3 participants 3 participants
0
   0.0%
1
  33.3%
5.Secondary Outcome
Title Number of Infectious Complications
Hide Description The number of infections complications occurring among study participants is presented here.
Time Frame Baseline up to Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Belatacept Treatment Group Control Group
Hide Arm/Group Description:
Participants with a failing kidney or failed kidney transplant receiving belatacept therapy
Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression
Overall Number of Participants Analyzed 6 7
Measure Type: Number
Unit of Measure: complications
12 18
Time Frame Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38).
Adverse Event Reporting Description

Adverse events were graded by the physician investigator as follows:

  • Mild (Grade 1): awareness of event but easily tolerated
  • Moderate (Grade 2): discomfort enough to cause some interference with usual activity
  • Severe (Grade 3): inability to carry out usual activity
  • Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
 
Arm/Group Title Belatacept Treatment Group Control Group
Hide Arm/Group Description Participants with a failing kidney or failed kidney transplant receiving belatacept therapy Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression
All-Cause Mortality
Belatacept Treatment Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   2/6 (33.33%)   1/7 (14.29%) 
Hide Serious Adverse Events
Belatacept Treatment Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   4/6 (66.67%)   5/7 (71.43%) 
Blood and lymphatic system disorders     
Deep vein thrombosis and pulmonary embolism *  1/6 (16.67%)  0/7 (0.00%) 
Cardiac disorders     
Acute myocardial infarction * [1]  0/6 (0.00%)  1/7 (14.29%) 
Atrial flutter *  1/6 (16.67%)  0/7 (0.00%) 
Gastrointestinal disorders     
Gastrointestinal bleed * [2]  1/6 (16.67%)  0/7 (0.00%) 
Diarrhea *  0/6 (0.00%)  1/7 (14.29%) 
General disorders     
Chest pain *  1/6 (16.67%)  0/7 (0.00%) 
Acute rejection *  0/6 (0.00%)  3/7 (42.86%) 
Hypertensive crisis with seizure *  0/6 (0.00%)  1/7 (14.29%) 
Posterior Reversible Encephalopathy syndrome *  0/6 (0.00%)  1/7 (14.29%) 
Infections and infestations     
Groin abscess *  1/6 (16.67%)  0/7 (0.00%) 
Cellulitis *  0/6 (0.00%)  1/7 (14.29%) 
Septic shock *  0/6 (0.00%)  1/7 (14.29%) 
Peritonitis with sepsis *  0/6 (0.00%)  1/7 (14.29%) 
Pneumonia related to H1N1 influenza culminating in death *  1/6 (16.67%)  0/7 (0.00%) 
Pneumonia *  0/6 (0.00%)  1/7 (14.29%) 
Infected permacath *  0/6 (0.00%)  1/7 (14.29%) 
Bacteremia *  1/6 (16.67%)  0/7 (0.00%) 
Escherichia coli urinary tract infection *  1/6 (16.67%)  0/7 (0.00%) 
Product Issues     
Peritoneal dialysis catheter blockage or malfunction *  1/6 (16.67%)  1/7 (14.29%) 
Renal and urinary disorders     
Initiation of hemodialysis *  1/6 (16.67%)  0/7 (0.00%) 
Increased creatinine *  1/6 (16.67%)  0/7 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pericardial effusion *  0/6 (0.00%)  2/7 (28.57%) 
Acute respiratory failure with hypoxia *  0/6 (0.00%)  1/7 (14.29%) 
Vascular disorders     
Exacerbation of hypertension *  2/6 (33.33%)  0/7 (0.00%) 
Malfunctionig arteriovenous (AV) fistula with edema *  1/6 (16.67%)  0/7 (0.00%) 
*
Indicates events were collected by non-systematic assessment
[1]
secondary to fatal arrythmia in the setting of ESRD
[2]
secondary to failing graft and end stage renal disease (ESRD)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Belatacept Treatment Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   7/7 (100.00%) 
Cardiac disorders     
Chest pain, grade 3 *  1/6 (16.67%)  0/7 (0.00%) 
Chest pain, grade 1 *  1/6 (16.67%)  4/7 (57.14%) 
Atrial flutter, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Atrial fibrillation, grade 1 *  1/6 (16.67%)  2/7 (28.57%) 
Aortic stenosis, grade 2 *  0/6 (0.00%)  1/7 (14.29%) 
Ear and labyrinth disorders     
Otitis media, grade 2 *  0/6 (0.00%)  5/7 (71.43%) 
Eustacian tube dysfunction, grade 2 *  0/6 (0.00%)  1/7 (14.29%) 
Right clogged ear, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Endocrine disorders     
Hyperparathyroidism, grade 2 *  1/6 (16.67%)  0/7 (0.00%) 
Hypoglycemia, grade 3 *  1/6 (16.67%)  0/7 (0.00%) 
Eye disorders     
Keratitis dendritic herpes, grade 2 *  0/6 (0.00%)  1/7 (14.29%) 
Scleral redness, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Gastrointestinal disorders     
Abdominal cramps, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Diarrhea, grade 1 *  3/6 (50.00%)  4/7 (57.14%) 
Diarrhea, grade 2 *  3/6 (50.00%)  2/7 (28.57%) 
Abdominal pain, grade 2 *  1/6 (16.67%)  0/7 (0.00%) 
Colitis, grade 3 *  0/6 (0.00%)  1/7 (14.29%) 
Vomiting, grade 2 *  1/6 (16.67%)  1/7 (14.29%) 
Vomiting, grade 3 *  1/6 (16.67%)  0/7 (0.00%) 
Diarrhea, grade 3 *  1/6 (16.67%)  0/7 (0.00%) 
Indigestion, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Sigmoid diverticulosis, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Internal hemorrhoids, grade 1 *  0/6 (0.00%)  1/7 (14.29%) 
General disorders     
Fatigue, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Fatigue, grade 2 *  3/6 (50.00%)  0/7 (0.00%) 
Nausea, grade 1 *  2/6 (33.33%)  2/7 (28.57%) 
Bilateral restless legs, grade 1 *  2/6 (33.33%)  0/7 (0.00%) 
Forgetfulness, grade 1 *  2/6 (33.33%)  0/7 (0.00%) 
Nervousness, grade 1 *  2/6 (33.33%)  0/7 (0.00%) 
Lesion on upper palate, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Hypocalcemia, grade 2 *  1/6 (16.67%)  0/7 (0.00%) 
Sycopal episode, grade 3 *  0/6 (0.00%)  1/7 (14.29%) 
Graft tenderness, grade 1 *  0/6 (0.00%)  2/7 (28.57%) 
Posterior reversible encephalopathy, grade 3 *  0/6 (0.00%)  1/7 (14.29%) 
Exacerbation of baseline anemia, grade 2 *  0/6 (0.00%)  1/7 (14.29%) 
Pericardial effusion, grade 3 *  0/6 (0.00%)  1/7 (14.29%) 
Acute pharyngitis, grade 2 *  0/6 (0.00%)  2/7 (28.57%) 
Shin injury, grade 2 *  0/6 (0.00%)  1/7 (14.29%) 
Cold sensitivity, grade 1 *  0/6 (0.00%)  1/7 (14.29%) 
Nausea, grade 3 *  1/6 (16.67%)  0/7 (0.00%) 
Lower extremity edema, grade 1 *  4/6 (66.67%)  0/7 (0.00%) 
Hyperkalemia, grade 2 *  1/6 (16.67%)  0/7 (0.00%) 
Hyperphosphatemia, grade 2 *  1/6 (16.67%)  0/7 (0.00%) 
Hypotension, grade 2 *  1/6 (16.67%)  0/7 (0.00%) 
Headache, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Hot flashes, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Asymmetry in right breast, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Intermittent bilateral foot swelling, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Hypokalemia, grade 2 *  1/6 (16.67%)  0/7 (0.00%) 
Dry cough, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Perihepatic ascites, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Weight loss, grade 2 *  1/6 (16.67%)  0/7 (0.00%) 
Bilateral hip edema, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Exacerbation of anemia, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Shaking, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Peritoneal catheter removal, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Exacerbation of insomnia, grade 2 *  1/6 (16.67%)  0/7 (0.00%) 
Weight gain, grade 2 *  1/6 (16.67%)  0/7 (0.00%) 
Syncopal episode, grade 3 *  0/6 (0.00%)  1/7 (14.29%) 
Fever, grade 2 *  0/6 (0.00%)  1/7 (14.29%) 
Hypervolemia, grade 1 *  0/6 (0.00%)  1/7 (14.29%) 
Enlarged axillary lymph node, grade 1 *  0/6 (0.00%)  1/7 (14.29%) 
Hypokalemia, grade 1 *  0/6 (0.00%)  2/7 (28.57%) 
Dizziness, grade 1 *  0/6 (0.00%)  1/7 (14.29%) 
Diaphoresis, grade 1 *  0/6 (0.00%)  1/7 (14.29%) 
Lower extremity swelling, grade 1 *  0/6 (0.00%)  1/7 (14.29%) 
Infections and infestations     
Peritonitis, grade 2 *  3/6 (50.00%)  4/7 (57.14%) 
Upper respiratory infection, grade 2 *  2/6 (33.33%)  0/7 (0.00%) 
Upper respiratory infection, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Urinary tract infection with bacteremia, grade 3 *  1/6 (16.67%)  0/7 (0.00%) 
Peritoneal dialysis site infection, grade 2 *  1/6 (16.67%)  0/7 (0.00%) 
Influenza A and B, grade 2 *  1/6 (16.67%)  0/7 (0.00%) 
Pneumonia, grade 2 *  1/6 (16.67%)  0/7 (0.00%) 
Shingles, grade 1 *  0/6 (0.00%)  2/7 (28.57%) 
Pneumonia, grade 3 *  0/6 (0.00%)  1/7 (14.29%) 
Cellulitis, grade 2 *  0/6 (0.00%)  1/7 (14.29%) 
Sinusitis, grade 2 *  0/6 (0.00%)  1/7 (14.29%) 
Viral syndrome, grade 2 *  0/6 (0.00%)  1/7 (14.29%) 
Febrile illness, grade 1 *  0/6 (0.00%)  2/7 (28.57%) 
Urinary tract infection, grade 2 *  1/6 (16.67%)  0/7 (0.00%) 
Peritonitis, grade 1 *  0/6 (0.00%)  1/7 (14.29%) 
Serratia bacteremia, grade 2 *  0/6 (0.00%)  1/7 (14.29%) 
Injury, poisoning and procedural complications     
Fractured toes due to motor vehicle accident, grade 2 *  1/6 (16.67%)  0/7 (0.00%) 
Burst bursa sac after fall, grade 2 *  1/6 (16.67%)  0/7 (0.00%) 
Metatarsal fracture, grade 2 *  0/6 (0.00%)  1/7 (14.29%) 
Metabolism and nutrition disorders     
Hypoglycemia, grade 2 *  2/6 (33.33%)  0/7 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia, grade 2 *  1/6 (16.67%)  0/7 (0.00%) 
Arthralgia, grade 1 *  2/6 (33.33%)  0/7 (0.00%) 
Left leg cramps, grade 2 *  1/6 (16.67%)  0/7 (0.00%) 
Bilateral feet cramps, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Disc protrusion, grade 2 *  1/6 (16.67%)  0/7 (0.00%) 
Facet joint hypertrophy, grade 2 *  1/6 (16.67%)  0/7 (0.00%) 
Tendonitis bilateral ankles, grade 1 *  2/6 (33.33%)  0/7 (0.00%) 
Knee meniscus tear, grade 2 *  1/6 (16.67%)  0/7 (0.00%) 
Osteoarthritis in knee, grade 2 *  1/6 (16.67%)  0/7 (0.00%) 
Leg pain possibly due to sciatica, grade 2 *  2/6 (33.33%)  0/7 (0.00%) 
Exacerbation of gout, grades 2 and 3 *  2/6 (33.33%)  0/7 (0.00%) 
Intermittent bone pain, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Intermittent jaw pain, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Scapular pain, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Intermittent hand cramping, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Muscle aches, grade 2 *  1/6 (16.67%)  0/7 (0.00%) 
Lower extremity weakness, grade 2 *  1/6 (16.67%)  0/7 (0.00%) 
Lower spine pain, grade 2 *  1/6 (16.67%)  0/7 (0.00%) 
Shoulder pain, grade 1 *  2/6 (33.33%)  0/7 (0.00%) 
Foot pain, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Weakness, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Joint pain, grade 1 *  0/6 (0.00%)  1/7 (14.29%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Squamous cell carcinoma, grades 1 and 2 *  1/6 (16.67%)  0/7 (0.00%) 
Multiple non-malignant skin lesions, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Product Issues     
Peritoneal dialysis catheter malfunction, grade 3 *  0/6 (0.00%)  1/7 (14.29%) 
Chest wall pain at site of dialysis catheter, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Psychiatric disorders     
Anxiety, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Altered mental status, grade 3 *  1/6 (16.67%)  0/7 (0.00%) 
Renal and urinary disorders     
Hematuria, grade 1 *  0/6 (0.00%)  2/7 (28.57%) 
Rise in creatinine, grade 2 *  0/6 (0.00%)  1/7 (14.29%) 
Pyelonephritis, grade 1 *  0/6 (0.00%)  1/7 (14.29%) 
Reproductive system and breast disorders     
Benign right ovarian cysts, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary edema, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Coughing and wheezing, grade 2 *  2/6 (33.33%)  0/7 (0.00%) 
Shortness of breath, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Chronic pulmonary embolus, grade 2 *  1/6 (16.67%)  0/7 (0.00%) 
Sinus congestion, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Skin and subcutaneous tissue disorders     
Pruritus, grade 2 *  2/6 (33.33%)  0/7 (0.00%) 
Hives bilateral lower leg, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Generalized urticaria, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Lip sore, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
Pressure ulcers on sacrum and coccyx, grade 3 *  1/6 (16.67%)  0/7 (0.00%) 
Surgical and medical procedures     
Knee replacement, grade 2 *  0/6 (0.00%)  1/7 (14.29%) 
Knee drainage, grade 1 *  0/6 (0.00%)  1/7 (14.29%) 
Lesions removed from arm, grade 2 *  1/6 (16.67%)  0/7 (0.00%) 
Vascular disorders     
Hypertension, grade 3 *  1/6 (16.67%)  1/7 (14.29%) 
Hypotension, grade 1 *  0/6 (0.00%)  1/7 (14.29%) 
Hypertensive crisis, grade 2 *  0/6 (0.00%)  2/7 (28.57%) 
Hypertension exacerbation, grade 1 *  1/6 (16.67%)  0/7 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Idelberto R. Badell, MD
Organization: Emory University
Phone: 404-712-6562
EMail: ibadell@emory.edu
Layout table for additonal information
Responsible Party: Andrew B Adams, Emory University
ClinicalTrials.gov Identifier: NCT01921218    
Other Study ID Numbers: IRB00060470
IM103-133 ( Other Identifier: Bristol-Myers Squibb )
First Submitted: August 9, 2013
First Posted: August 13, 2013
Results First Submitted: December 11, 2020
Results First Posted: January 26, 2021
Last Update Posted: January 26, 2021