Randomized Conversion of Calcineurin-Inhibitors in Renal Allograft Recipients
Completed · Phase 4
Conditions studied: Renal Transplant Rejection
In brief
This study is being done to investigate the impact of changing immunosuppressive medications from tacrolimus (Prograf®) to sirolimus (Rapamune®) between 6 and 24 months post transplant. The primary purpose of this research study is to evaluate whether the use of mycophenolate mofetil(MMF)/Cellcept® and tacrolimus(TAC)/Prograf® (Group 1) or mycophenolate mofetil(MMF)/Cellcept® and sirolimus/Rapamune® (Group 2) impacts the incidence of acute cellular rejection in post kidney transplant patients. This study will examine whether switching from tacrolimus to sirolimus will better preserve long-term kidney function.
Key facts
- Study ID
- NCT00866879
- Run by
- Northwestern University
- People needed
- 275
- Starts
- 2007-06-01
- Expected to finish
- 2019-03-01
- Last updated by the study team
- 2019-06-28
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects should be adults ≥ 18- ≤ 70 years of age
- Subjects can be either gender or of any ethnic background
- Subjects should be single organ recipients (kidney only)
- Subjects must be able to understand the protocol and provide informed consent.
You may not qualify if…
- Subjects with end-stage renal disease (ESRD) secondary to primary focal segmental glomerulonephritis (FSGS).
- Inability to comply with study procedures
- Inability to sign the informed consent
- Subjects with a significant or active infection
- Subjects who are pregnant or nursing females
- Subjects with a history of severe hyperlipidemia not controlled with statins, patients with at total cholesterol of > 400 mg/dl
- Subjects with a platelet count <100,000mm3 white blood cell (WBC)< 2,000mm3
- Subjects with severe proteinuria at the time of randomization (>2gm/day)
- Subjects with more then 2 episodes of acute cellular rejection post transplantation will be excluded from this study
- An estimated GFR<40 cc/min
- A history of malignancy during the post-transplant period (other than treated basal cell cancer and/or squamous cell cancer)
- Subjects, who, due to the existence of a surgical, medical or psychiatric condition, other than the current transplant, which in the opinion of the investigator, precludes enrollment into this trial
- A history of albumin-creatinine ratio (ACR) during the most recent previous 3 months prior to randomization
Where it is running
- Northwestern Memorial Hospital — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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