Status:
COMPLETED
Randomized Conversion of Calcineurin-Inhibitors in Renal Allograft Recipients
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Renal Transplant Rejection
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
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 pu...
Detailed Description
For this research study, between 6 and 24 Months post-transplant, we plan to prospectively randomize 2:1 renal transplant patients to either: * Substitute tacrolimus (TAC) with sirolimus and continue...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT00866879
Start Date
June 1 2007
End Date
March 1 2019
Last Update
June 28 2019
Active Locations (1)
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1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611