Status:
COMPLETED
Tacrolimus/Sirolimus Versus Tacrolimus/Mycophenolate Mofetil (MMF) Versus Neoral/Sirolimus in Adult, Primary Kidney Transplantation
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Wyeth-Ayesrst Pharmaceuticals, Roche Laboratories, and Fujusawa Healthcare, Inc.
Conditions:
Adult Primary Kidney Transplantation
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief Summary
Comparison of outcomes/safety/and tolerability of SRL/FK/Pred vs. FK/MMF/Pred vs. SRL/Neoral®/Pred in cadaveric and non-HLA identical LRD kidney transplants.
Eligibility Criteria
Inclusion
- Age \>14 years
- Weight \> 40 kg
- Primary renal allograft: cadaveric or mismatched living donor
- Negative standard cross match for T-cells
- Women of childbearing potential will be required to have a negative qualitative serum pregnancy test and agree to use an adequate method of contraception throughout the study period and for 3 months after discontinuation of study medication (3yrs, 3 mos.)
- Signed and dated informed consent (Parent or legal guardian must provide written consent for patients \<18 years of age)
Exclusion
- Evidence of systemic infection
- History of malignancy within 10 years (with the exception of localized skin cancer)
- Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the 12-month treatment phase
- Concurrent use of astemizole, pimozide, cisapride, terfenadine, or ketoconazole
- Known hypersensitivity to sirolimus and its derivatives
- Patients with a screening/baseline (or within 96 hours of transplant)
- total white blood cell count \< 4000/mm3;
- platelet count \< 100,000/mm3;
- fasting triglycerides \> 400 mg/dl (\> 4.6 mmol/L);
- fasting total cholesterol \> 300 mg/dl (\> 7.8 mmol/L);
- fasting HDL-cholesterol \< 30 mg/dl;
- fasting LDL-cholesterol \> 200mg/dl
Key Trial Info
Start Date :
May 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2002
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00681213
Start Date
May 1 2000
End Date
December 1 2002
Last Update
September 22 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Miami Division of Transplantation
Miami, Florida, United States, 33136