Status:
TERMINATED
Renal Allograft Function and Histology Following Switching From A Tacrolimus to Sirolimus (SRL)-Based Immunosuppression-
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Pfizer
Conditions:
Kidney Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The investigators hypothesize that Tacrolimus (Tac) withdrawal from a Tac, MMF and steroid based triple therapy regimen leads to long term improved/stabilized graft function (glomerular filtration rat...
Detailed Description
We will test this hypothesis in an open label controlled trial where stable renal allograft recipients on Tac, MMF, prednisone maintenance immunosuppression will undergo renal biopsy at 3-4 months pos...
Eligibility Criteria
Inclusion
- Absence of clinical acute rejection in post-transplant period preceding randomization
- HLA-mismatched solitary first and second kidney transplant recipients
- Absence of any degree of rejection (Banff 2007) on renal biopsy at 3-6 months(+/- 2 months) post-transplant.
- Absence of post-transplant donor-specific antibody
Exclusion
- HLA-identical transplants
- Contraindication or inability to undergo renal biopsy, like previous complications due to biopsies, anticoagulation, active infection, etc.
- Positive flow cross match, sensitized recipient, presence of donor-specific antibody.
- Rejection episode after transplantation, either cellular or humoral on for cause or renal biopsy.
- Rejection present on pre-randomization renal biopsy.
- Proteinuria greater than 0.3 gram/day
- Native kidney disease biopsy proven or likely glomerulonephritis, primary or recurrent FSGS, MPGN or primary or recurrent membranous GN.
- Hypertriglyceridemia \> 400 mg/dL (treated), LDL cholesterol \> 160 mg/dL while on optimal treatment.
- WBC \< 2000/mm3, ANC \< 1000 mm3, Platelet count \< 100,000 mm3
- Active wound issues.
- Primary non-function.
- Active BKV or CMV disease.
- Evidence of recurrent disease.
- Active infection
- Pregnancy
- Women of childbearing potential unable or unwilling to use birth control during the study.
- e GFR ≤ 40 ml/ min at screening
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01166724
Start Date
July 1 2010
End Date
December 1 2014
Last Update
June 7 2017
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195