Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02866682 |
| Other study ID # |
14-001423 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2018 |
| Est. completion date |
June 11, 2021 |
Study information
| Verified date |
April 2023 |
| Source |
University of California, Los Angeles |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
As the patents for brand-name immunosuppressive medications expire, there is increasing
interest in using generic immunosuppressive drugs. However, despite pharmacokinetic studies
showing bioequivalence, questions remain regarding the clinical impact of use of generic
immunosuppression.
The most important immunosuppressive agent in the modern transplant era is arguably
tacrolimus, a calcineurin-inhibitor with a narrow therapeutic index. This study seeks to
answer the question regarding the clinical impact of generic tacrolimus use as measured
primarily by acute rejection, loss of graft function, and patient death through a randomized
trial of 2 phases: Brand tacrolimus only, and Generic A tacrolimus only. Given that kidney
transplantations are the most commonly performed transplants with well-defined measures of
rejection and graft failure, this organs will be studied in a six-center study designed to
accrue the target number of transplant recipients within the one-year study period.
The study has now been branched off into 2 phases. Phase 1: consists of randomization of
patients onto brand and generic tacrolimus. This was completed once 40 brand patients were
enrolled. Phase 2: consists of patients being enrolled only on generic tacrolimus (standard
of care from subject's insurance). This will be completed once there is a total of 160
generic participants. 200 participants total in the study.
Description:
A prospective, randomized, open-label, multicenter, parallel, observational study to assess
safety and efficacy of 200 kidney transplant recipients comparing brand tacrolimus to generic
tacrolimus over a one year follow up period. All subjects will receive other
immunosuppressive medications including induction therapy (thymoglobulin, basiliximab, or no
induction) and maintenance including mycophenolate mofetil and corticosteroid therapy as
directed by standard-of-care at each center. Their medication information will be recorded in
their study files.
The study population includes recipients of kidney allografts in the first 14 days after
transplantation.
The totals of 7 visits over 12 months period are planned as follows. The blood samples
specified below are for the translational research study labs. Subjects will continue to
receive routine labs as part of their standard of care from their treating physician. These
safety labs are done as part of their stand of care from their treating physician.
If the subject needs more study drug medication before his or her next study visit the
subject will come in to the clinic to get a new supply.
First (Baseline) Visit (up to 14 days after transplant but before you are discharged from the
hospital):
- Review and sign this consent form
- Review of your medical history
- Review of your current medications
- Review of your physical exam including vital signs (blood pressure, temperature, pulse
and respiration rate), height and weight
- Review of clinical labs
- You will receive your study drug if you are in Part 1 of the study.
If you are a woman of child bearing potential, a pregnancy test will be completed prior to
the start of the study. If you are pregnant, you cannot participate in this research study.
You also cannot participate in this study if you are currently breastfeeding. You must use a
medically acceptable method of birth control during the 1-year study period and for 6 weeks
after the last dose of study medication.
It is possible that after the study doctor reviews your medical history and test results, he
or she may tell you that you do not qualify to be in the study. If you do not qualify for the
study, the doctor will tell you the reason(s) why. If you cannot be in this research study,
you will not lose any medical benefits, you can still participate in other studies, and you
can still receive the standard treatment prescribed by your physician.
After the Baseline Visit, you will have 6 additional study visits. These will be scheduled
for 1, 2, 3, 6, 9, and 12 months after your transplant surgery. The following will occur at
each visit:
Month 1, 2, 3, 6, and 9 Visits:
- Review of your current medications
- Review of your physical exam including vital signs (blood pressure, temperature, pulse
and respiration rate), height and weight
- Review of any changes in your health and any reactions to the study medication will be
recorded
- Review of your routine standard of care lab results
- Return completed dosing diary and receive new dosing diary
- You will receive your study drug if you are in Part 1 of the study
Month 12 Visit (End of Study Visit):
- Review of your current medications
- Review of any changes in your health and any reactions to the study medication will be
recorded
- Review of your routine standard of care lab result
- Return your final completed dosing diary
- Return any study drug remaining in your possession to the study team if you are in Part
1 of the study
If you are Part 1 and require more study medication before your next study visit, you will
come in to the clinic to get a new supply. If you are participating in Part 2, you will
obtain more study drug from your local pharmacy.
You will continue having your routine blood and urine collections to monitor your kidney
function as part of your standard of care treatment at UCLA, UCSD, UCI, and UCD. The schedule
for these routine blood and urine collections will depend on your condition and will be at
your treating physician's discretion.
Adherence will be measured with daily medication diaries and with the coefficient of
variation of tacrolimus in subjects' blood.
