Tacrolimus/Sirolimus Versus Tacrolimus/Mycophenolate Mofetil (MMF) Versus Neoral/Sirolimus in Adult, Primary Kidney Transplantation

• Status: Completed
• Trial end date: 2002-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Collaborator: Wyeth-Ayesrst Pharmaceuticals, Roche Laboratories, and Fujusawa Healthcare, Inc.
• Treatments: Cyclosporine; Cyclosporins; Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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