A Study Comparing Brand and Generic Tacrolimus After Kidney Transplant

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: kidney transplant, renal transplant rejection, kidney rejection, anti-rejection medication
Type: Drug study, Phase 4
Target:
408 Participants
Investigator:
Description
This study is for patients who have recently received a kidney transplant and are taking tacrolimus.

The study will compare the effectiveness and safety of generic tacrolimus to the brand tacrolimus (Prograf).

Tacrolimus is the standard of care treatment. It is used to prevent the body’s immune system from rejecting the transplanted organ.
This study requires

There will be 2 study groups. The chance of being in each study group will be 2:1 and you will be randomly assigned to a treatment based on chance. Neither you nor the study investigators choose your assigned group.

As long as you remain eligible for the study, you will receive your study medication from the study team for the one year study duration:

  • Group 1 will receive brand tacrolimus (Prograf) for the entire study (12 months).
  • Group 2 will receive generic tacrolimus for the entire study (12 months).

You will start receiving your study medication before you leave the hospital after your transplant surgery.

Who can participate

Inclusion Criteria 1. Signed informed consent and or/assent 2. Between the ages of 18 and 70 years, inclusive 3. Current or future kidney transplant recipients, no more than 14 days after transplant and prior to hospital discharge. Inclusion of future kidney transplant recipients cannot exceed 30-days pre-transplant. 4. Able to swallow tablets and capsules at the time of randomization 5. Subjects must be receiving a primary or secondary kidney allograft from a deceased donor or from a non- HLA identical living donor 6. Negative cross match test, and compatible (A, B, AB or O) blood type 7. Subjects must have no known contraindications to tacrolimus 8. Women of childbearing potential (WOCBP) must have a negative pregnancy test and be willing to use 2 methods of contraception during the study and for 6 weeks after stopping the study drug.

Exclusion Criteria

  1. Those who receive simultaneous combined organ transplants
  2. Subjects with clinically significant active infections (for example, those requiring hospitalization, or as judged by the Investigator) or malignancies
  3. Recipients who are concurrently receiving belatacept or anticipate to receive belatacept as part of their immunosuppressive regimen
  4. Subjects currently enrolled in another investigational device or drug study
  5. WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for 6 weeks after stopping the study drug
  6. Women who are breast-feeding or pregnant with a positive pregnancy test on enrollment or prior to study drug administration
  7. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
  8. Any psychiatric or medical condition that, in the investigator’s opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject’s participation in the study.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
Your participation in this research study will last about 12 months.
Recruitment period
From Aug. 21, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Macey Sockolov
Research Topic
Conditions:
  • Renal Transplant Rejection

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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