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Prospective Study Comparing Brand and Generic Immunosuppression on Transplant Outcomes, Adherence, & Immune Response in Kidney Transplant Recipients

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: NCT02866682
Recruitment Status : Completed
First Posted : August 15, 2016
Results First Posted : April 28, 2023
Last Update Posted : April 28, 2023
Sponsor:
Collaborator:
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
Suphamai Bunnapradist, University of California, Los Angeles

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Renal Transplant Rejection
Interventions Drug: Prograf
Drug: Tacrolimus
Enrollment 176
Recruitment Details  
Pre-assignment Details 5 participants withdrew prior to randomization.
Arm/Group Title Brand Tacrolimus Only : Prograf Generic A Only
Hide Arm/Group Description

Arm 1 will receive brand tacrolimus for the entire study

Prograf: Brand Drug for the duration of the study.

Arm 2 will receive specific generic tacrolimus for the entire study

Tacrolimus: Generic
Period Title: Overall Study
Started 39 132
Completed 39 120
Not Completed 0 12
Reason Not Completed
Death             0             1
Lost to Follow-up             0             4
Tacrolimus Discontinued During Study             0             6
Other             0             1
Arm/Group Title Brand Tacrolimus Only : Prograf Generic A Only Total
Hide Arm/Group Description

Arm 1 will receive brand tacrolimus for the entire study

Prograf: Brand Drug for the duration of the study.

Arm 2 will receive specific generic tacrolimus for the entire study

Tacrolimus: Generic

 Total of all reporting groups
Overall Number of Baseline Participants 39 132 171
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 132 participants 171 participants
53.0  (12.7) 52.2  (13.1) 52.5  (13.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 132 participants 171 participants
Female
15
  38.5%
58
  43.9%
73
  42.7%
Male
24
  61.5%
74
  56.1%
98
  57.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 39 participants 132 participants 171 participants
White, Non-Hispanic
9
  23.1%
33
  25.0%
42
  24.6%
Black
5
  12.8%
12
   9.1%
17
   9.9%
Asian
3
   7.7%
12
   9.1%
15
   8.8%
Hispanic or Latino
12
  30.8%
50
  37.9%
62
  36.3%
Multiracial
6
  15.4%
25
  18.9%
31
  18.1%
American Indian or Alaska Native
4
  10.3%
0
   0.0%
4
   2.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 39 participants 132 participants 171 participants
39
 100.0%
132
 100.0%
171
 100.0%
1.Primary Outcome
Title Time to First Occurrence of Acute Rejection, Failure, Death
Hide Description The definition of graft failure includes re-transplant and/or death and, in case of kidney transplant, also includes return to dialysis. Acute rejection was defined as biopsy-proven rejection according to Banff 2007 criteria. Please see the following article for details of the Banff '07 classification: https://www.sciencedirect.com/science/article/pii/S1600613522056428?via%3Dihub.
Time Frame 1 year post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
No participants experienced graft rejection or death in the Brand Tacrolimus group. Only 1 participant on the Brand group experienced graft failure. On the other hand, the generic group had 9 participants that experienced rejection, 1 that experienced graft failure, and 1 that experienced death.
Arm/Group Title Brand Tacrolimus Only : Prograf Generic A Only
Hide Arm/Group Description:

Arm 1 will receive brand tacrolimus for the entire study

Prograf: Brand Drug for the duration of the study.

Arm 2 will receive specific generic tacrolimus for the entire study

Tacrolimus: Generic
Overall Number of Participants Analyzed 1 11
Mean (Standard Deviation)
Unit of Measure: days
Time to first of rejection Number Analyzed 0 participants 9 participants
57.1  (66.5)
Time to first graft failure Number Analyzed 1 participants 1 participants
86 200
Time to first death Number Analyzed 0 participants 1 participants
200
2.Secondary Outcome
Title Number of Participants With Graft Rejection at 1 Year
Hide Description Rejection was defined as biopsy-proven rejection according to Banff 2007 criteria. Please see the following article for details of the Banff '07 classification: https://www.sciencedirect.com/science/article/pii/S1600613522056428?via%3Dihub.
Time Frame 1 year post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brand Tacrolimus Only : Prograf Generic A Only
Hide Arm/Group Description:

Arm 1 will receive brand tacrolimus for the entire study

Prograf: Brand Drug for the duration of the study.

Arm 2 will receive specific generic tacrolimus for the entire study

Tacrolimus: Generic
Overall Number of Participants Analyzed 39 120
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
9
   7.5%
3.Secondary Outcome
Title Number of Participants With Graft Failure at 1 Year
Hide Description Graft failure as determined by return to dialysis, death, or re-transplant
Time Frame 1 year post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brand Tacrolimus Only : Prograf Generic A Only
Hide Arm/Group Description:

Arm 1 will receive brand tacrolimus for the entire study

Prograf: Brand Drug for the duration of the study.

Arm 2 will receive specific generic tacrolimus for the entire study

Tacrolimus: Generic
Overall Number of Participants Analyzed 39 120
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.6%
1
   0.8%
4.Secondary Outcome
Title Number of Participants With Infectious Episodes at 1 Year
Hide Description Infectious episodes are defined as a positive test result for an infection.
Time Frame 1 year post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brand Tacrolimus Only : Prograf Generic A Only
Hide Arm/Group Description:

Arm 1 will receive brand tacrolimus for the entire study

Prograf: Brand Drug for the duration of the study.

Arm 2 will receive specific generic tacrolimus for the entire study

Tacrolimus: Generic
Overall Number of Participants Analyzed 39 120
Measure Type: Number
Unit of Measure: participants
Cytomegalovirus infection 10 22
BK virus infection 3 16
Other infection 15 34
5.Secondary Outcome
Title Number of Participants With Malignancy at 1 Year
Hide Description Malignancy is defined as physician reported malignancy according to review of participants' medical history.
Time Frame 1 year post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brand Tacrolimus Only : Prograf Generic A Only
Hide Arm/Group Description:

Arm 1 will receive brand tacrolimus for the entire study

Prograf: Brand Drug for the duration of the study.

Arm 2 will receive specific generic tacrolimus for the entire study

Tacrolimus: Generic
Overall Number of Participants Analyzed 39 132
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   0.8%
6.Secondary Outcome
Title Death or Loss-to-follow-up at 1 Year
Hide Description [Not Specified]
Time Frame 1 year post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brand Tacrolimus Only : Prograf Generic A Only
Hide Arm/Group Description:

Arm 1 will receive brand tacrolimus for the entire study

Prograf: Brand Drug for the duration of the study.

Arm 2 will receive specific generic tacrolimus for the entire study

Tacrolimus: Generic
Overall Number of Participants Analyzed 39 132
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
5
   3.8%
7.Secondary Outcome
Title Changes in Lymphocyte Subpopulations and Production of Donor Specific HLA Antibodies
Hide Description [Not Specified]
Time Frame post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome was not collected or measured due to approved changes in protocol amendment
Arm/Group Title Brand Tacrolimus Only : Prograf Generic A Only
Hide Arm/Group Description:

Arm 1 will receive brand tacrolimus for the entire study

Prograf: Brand Drug for the duration of the study.

Arm 2 will receive specific generic tacrolimus for the entire study

Tacrolimus: Generic
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Number of Participants Who Adhered to Medication Regimen
Hide Description Patient adherence was assessed by their physician with participants marked as "adherent," "non-adherent," or "unknown."
Time Frame post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Remaining participants did not have adherence data collected due to appointment cancellations during Covid-19 pandemic
Arm/Group Title Brand Tacrolimus Only : Prograf Generic A Only
Hide Arm/Group Description:

Arm 1 will receive brand tacrolimus for the entire study

Prograf: Brand Drug for the duration of the study.

Arm 2 will receive specific generic tacrolimus for the entire study

Tacrolimus: Generic
Overall Number of Participants Analyzed 37 106
Measure Type: Count of Participants
Unit of Measure: Participants
37
 100.0%
105
  99.1%
9.Secondary Outcome
Title Quality of Life With Medication Regimen
Hide Description [Not Specified]
Time Frame post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
This was not collected due to protocol amendment changes which no longer required this outcome data.
Arm/Group Title Brand Tacrolimus Only : Prograf Generic A Only
Hide Arm/Group Description:

Arm 1 will receive brand tacrolimus for the entire study

Prograf: Brand Drug for the duration of the study.

Arm 2 will receive specific generic tacrolimus for the entire study

Tacrolimus: Generic
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Satisfaction With Medication Regimen
Hide Description [Not Specified]
Time Frame post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome not measured or collected due to approved changes in protocol amendment
Arm/Group Title Brand Tacrolimus Only : Prograf Generic A Only
Hide Arm/Group Description:

Arm 1 will receive brand tacrolimus for the entire study

Prograf: Brand Drug for the duration of the study.

Arm 2 will receive specific generic tacrolimus for the entire study

Tacrolimus: Generic
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 Year Post-Transplant
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Brand Tacrolimus Only : Prograf Generic A Only
Hide Arm/Group Description

Arm 1 will receive brand tacrolimus for the entire study

Prograf: Brand Drug for the duration of the study.

Arm 2 will receive specific generic tacrolimus for the entire study

Tacrolimus: Generic
All-Cause Mortality
Brand Tacrolimus Only : Prograf Generic A Only
Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)      1/132 (0.76%)    
Hide Serious Adverse Events
Brand Tacrolimus Only : Prograf Generic A Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/39 (48.72%)      43/132 (32.58%)    
General disorders     
Life threatening event associated with an immediate risk of death †  0/39 (0.00%)  0 1/132 (0.76%)  1
Re-hospitalization †  13/39 (33.33%)  30 41/132 (31.06%)  98
Prolonged hospitalization †  10/39 (25.64%)  15 6/132 (4.55%)  6
Important medical event requiring medical intervention † [1]  1/39 (2.56%)  1 1/132 (0.76%)  1
†
Indicates events were collected by systematic assessment
[1]
The patient had an important medical event that, based upon the investigator's medical judgment, may significantly jeopardize the patient's health and require medical or surgical intervention to prevent negative outcomes
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Brand Tacrolimus Only : Prograf Generic A Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32/39 (82.05%)      105/132 (79.55%)    
Blood and lymphatic system disorders     
Anemia †  6/39 (15.38%)  33/132 (25.00%) 
Thrombocytopenia †  4/39 (10.26%)  8/132 (6.06%) 
Cardiac disorders     
Hypotension †  4/39 (10.26%)  10/132 (7.58%) 
Hypertension †  1/39 (2.56%)  11/132 (8.33%) 
Orthostatic Hypotension †  0/39 (0.00%)  8/132 (6.06%) 
Endocrine disorders     
Secondary Hyperparathyroidism †  2/39 (5.13%)  0/132 (0.00%) 
Uncontrolled Diabetes †  2/39 (5.13%)  1/132 (0.76%) 
Gastrointestinal disorders     
Abdominal Pain †  6/39 (15.38%)  14/132 (10.61%) 
Constipation †  5/39 (12.82%)  17/132 (12.88%) 
Diarrhea †  11/39 (28.21%)  27/132 (20.45%) 
Gastroesophageal reflux disease †  4/39 (10.26%)  9/132 (6.82%) 
Nausea †  4/39 (10.26%)  16/132 (12.12%) 
General disorders     
Edema †  1/39 (2.56%)  7/132 (5.30%) 
Fatigue †  2/39 (5.13%)  3/132 (2.27%) 
Headache †  3/39 (7.69%)  5/132 (3.79%) 
Pyrexia †  2/39 (5.13%)  9/132 (6.82%) 
Vomiting †  3/39 (7.69%)  5/132 (3.79%) 
Weight Gain †  2/39 (5.13%)  7/132 (5.30%) 
Hepatobiliary disorders     
Transaminitis †  9/39 (23.08%)  27/132 (20.45%) 
Immune system disorders     
Leukocytosis †  7/39 (17.95%)  15/132 (11.36%) 
Leukopenia †  12/39 (30.77%)  41/132 (31.06%) 
Neutropenia †  5/39 (12.82%)  6/132 (4.55%) 
de novo DSA †  3/39 (7.69%)  1/132 (0.76%) 
Infections and infestations     
Infection †  20/39 (51.28%)  55/132 (41.67%) 
Injury, poisoning and procedural complications     
Incisional Pain †  5/39 (12.82%)  7/132 (5.30%) 
Post Operative Pain †  0/39 (0.00%)  19/132 (14.39%) 
Metabolism and nutrition disorders     
Hypercalcemia †  13/39 (33.33%)  20/132 (15.15%) 
Hyperglycemia †  2/39 (5.13%)  21/132 (15.91%) 
Hyperkalemia †  14/39 (35.90%)  41/132 (31.06%) 
Hyperphosphatemia †  7/39 (17.95%)  11/132 (8.33%) 
Hypocalcemia †  4/39 (10.26%)  14/132 (10.61%) 
Hypokalemia †  4/39 (10.26%)  5/132 (3.79%) 
Hypomagnesimia †  14/39 (35.90%)  59/132 (44.70%) 
Hypophosphatemia †  12/39 (30.77%)  51/132 (38.64%) 
Impaired Fasting Blood Glucose †  8/39 (20.51%)  6/132 (4.55%) 
Metabolic Acidosis †  12/39 (30.77%)  29/132 (21.97%) 
Musculoskeletal and connective tissue disorders     
Tremor †  5/39 (12.82%)  24/132 (18.18%) 
Renal and urinary disorders     
Acute Kidney Injury †  9/39 (23.08%)  30/132 (22.73%) 
Hematuria †  5/39 (12.82%)  10/132 (7.58%) 
Lower extremity edema †  6/39 (15.38%)  6/132 (4.55%) 
Pyuria †  9/39 (23.08%)  10/132 (7.58%) 
Abnormal Urinalysis †  2/39 (5.13%)  0/132 (0.00%) 
Elevated BUN †  2/39 (5.13%)  0/132 (0.00%) 
Kidney Transplant Rejection †  0/39 (0.00%)  9/132 (6.82%) 
Proteinuria †  2/39 (5.13%)  1/132 (0.76%) 
Respiratory, thoracic and mediastinal disorders     
Cough †  3/39 (7.69%)  5/132 (3.79%) 
Dyspnea †  2/39 (5.13%)  7/132 (5.30%) 
Skin and subcutaneous tissue disorders     
Alopecia †  1/39 (2.56%)  11/132 (8.33%) 
Vascular disorders     
Deep Vein Thrombosis †  2/39 (5.13%)  4/132 (3.03%) 
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Dr. Suphamai Bunnapradist
Organization: University of California, Los Angeles (UCLA)
Phone: 310-794-8516
EMail: bunnapradist@mednet.ucla.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Suphamai Bunnapradist, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02866682    
Other Study ID Numbers: 14-001423
First Submitted: July 26, 2016
First Posted: August 15, 2016
Results First Submitted: December 9, 2022
Results First Posted: April 28, 2023
Last Update Posted: April 28, 2023