Antibody and Delayed Cyclosporine Versus Initial Cyclosporine Alone in Patients Receiving Kidney Transplants
- Conditions
- Kidney TransplantationChronic Allograft Nephropathy
- Interventions
- Registration Number
- NCT00007787
- Brief Summary
The purpose of this study is to see if kidney function can be improved during transplants by giving the drug Thymoglobulin with delayed cyclosporine treatment instead of initial cyclosporine treatment.
There have been improvements for patients receiving kidney transplants, yet acute rejection is still a problem. This can lead to kidney failure over time. Patients whose graft fails to function properly in the first week after transplant do not do as well after 5 years as compared to patients without early problems. This study will see if Thymoglobulin, a drug that suppresses the immune system, will improve early graft function.
- Detailed Description
While graft survival of post renal transplant has improved over the last decades, acute rejection remains a problem that clinical research has sought to minimize through improved strategies. Graft survival prognosis is significantly worsened in patients whose allografts exhibit delayed function and patients may require early dialysis. Data shows that cadaveric organ recipients requiring dialysis use in the first transplant week have a 5-year post-graft survival rate of 51 percent compared to 70 percent for those free of this complication. A recent evaluation of Thymoglobulin (a rabbit-derived polyclonal antibody; an immunosuppressant) suggests it is an effective agent worthy of further evaluation as induction therapy. This trial evaluates whether a decreased DGF is seen with an improved Day 90 graft function.
Recipients of a first or second cadaver kidney transplant are randomized pre-transplant to 1 of 2 treatment groups. One group receives antibody therapy (Thymoglobulin) at the time of transplant and delayed cyclosporine therapy. The other group starts cyclosporine therapy at the time of transplant without Thymoglobulin. DGF is diagnosed by a less than 20 percent decrease in the serum creatinine levels in the first 24 hours post-transplant and/or the need for dialysis. Patients on the antibody arm receive additional antibody if they experience DGF. Biopsies are performed in all cases of suspected rejection and any patient with biopsy-confirmed acute cellular rejection receives treatment. Patients have regular examinations including blood tests and are evaluated for kidney function and incidence of complications for 24 months after the transplant. The trial endpoint of graft function encompasses graft survival and graft function as calculated by creatinine clearance.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 350
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Antibody plus delayed cyclosporine therapy Cyclosporine Anti-human thymocyte globulin (rabbit) (Thymoglobulin®) is admistred at the time of transplant followed delayed clyclosporine A therapy post tranplant. Antibody plus delayed cyclosporine therapy Anti-human thymocyte globulin (rabbit) Anti-human thymocyte globulin (rabbit) (Thymoglobulin®) is admistred at the time of transplant followed delayed clyclosporine A therapy post tranplant. Standard cyclosporine A therapy Cyclosporine Cyclosporine A therapy (either Cyclosporine or Tacrolimus) will be initiated pre-transplantations Antibody plus delayed cyclosporine therapy Tacrolimus Anti-human thymocyte globulin (rabbit) (Thymoglobulin®) is admistred at the time of transplant followed delayed clyclosporine A therapy post tranplant. Standard cyclosporine A therapy Tacrolimus Cyclosporine A therapy (either Cyclosporine or Tacrolimus) will be initiated pre-transplantations
- Primary Outcome Measures
Name Time Method Graft function measurnment 3 months measured by a calculated creatinine clearance. Creatinine Clearance for males will be computed using the following: \[weight in kg \* (140 - age in years)\]/ \[72 \* serum creatinine mg/dl\]. For females, eighty-five percent of this value will be used.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ilene Blechman-Krom
🇺🇸Rockville, Maryland, United States