Clinical Trial: Tacrolimus to Sirolimus Conversion for Delayed Graft Function
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Delayed Tacrolimus to Sirolimus Conversion in Renal Transplant Recipients With Delayed Graft Function
Brief Summary: The objective of this study is to evaluate the safety and efficacy of conversion from tacrolimus to sirolimus early after kidney transplantation in patients with delayed graft function (DGF)and slow graft function (SGF) in improving graft function and delaying chronic allograft nephropathy. The investigators hypothesize that conversion from tacrolimus to sirolimus in renal transplant recipients with DGF/SGF in early months after surgery will improve graft function and decrease the progression of graft fibrosis.
Detailed Summary:
Eligible study subjects will be randomized into two groups 8-18 weeks after surgery. One group will be maintained on tacrolimus according to the standard of care at our center. In the second group tacrolimus will be converted to sirolimus, with one week overlap between sirolimus therapy and tacrolimus taper. All the deceased donor kidney transplant recipients transplanted at our center who experience DGF/SGF are eligible for inclusion in this study, if they meet the inclusion/exclusion criteria as detailed later.
Data will be collected on patient demographics, duration on dialysis, history of diabetes and chronic hepatitis C, previous transplantation, PRA, donor source, warm and cold ischemia time, donor demographics and comorbidity such as diabetes and hypertension, serum creatinine at the time of organ removal, early graft function, number of dialysis treatments after transplantation, induction agent and immunosuppressive regimen including the dose or level of the drugs at 3, 6, 9, 12, 18, and 24 months. Similar data regarding use of ACE inhibitors/ARBs, erythropoietic agents, number of anti-hypertensives and lipid lowering agents will be collected. In addition, the following tests and procedures will be obtained for this study.
- GFR measurement by cold iothalamate method at one year after transplantation.
- Evaluation of routine surveillance graft biopsies for chronic changes at 3 and 12 months posttransplant by morphometric analysis.
- Spot urine protein, albumin, and creatinine measurement at 3 and 12 months.
- Estimate GFR at 3, and 12 months using MDRD, CG, and Nankivell formulas
- Examine the surveillance and indicated biopsies for acute rejection and BK
Sponsor: University of Maryland
Current Primary Outcome: The composite endpoint of reduction of e eGFR at one year by more than 15% & the progression in fibrosis score at one year by >=20% compared with the baseline values [ Time Frame: One year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- eGFR [ Time Frame: One year ]
- Change in eGFR from baseline to 1-year [ Time Frame: 1 year ]
- Graft survival (Actual, Actuarial) [ Time Frame: 1 year; up to 3 years ]
- Patient survival (Actual and Actuarial) [ Time Frame: 1-year; up to 3 years ]
- Incidence & severity of acute rejection (Actual, Actuarial) [ Time Frame: 1 year; up to 3 years ]
- Incidence of development of DSA [ Time Frame: Up to 3 years ]
- Incidence of BK nephropathy (Cumulative) [ Time Frame: Up to 3 years ]
- Change in inflammatory markers (including IL-6, MCP, CRP)from baseline [ Time Frame: 1 year ]
Original Secondary Outcome: Same as current
Information By: University of Maryland
Dates:
Date Received: June 29, 2009
Date Started: April 2009
Date Completion: February 2012
Last Updated: December 14, 2009
Last Verified: December 2009
