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

Phase 4

Completed

• Conditions: Adult Primary Kidney Transplantation
• Interventions: Drug: Tacrolimus/Sirolimus; Drug: Neoral/Sirolimus; Drug: Tacrolimus/MMF

• Registration Number: NCT00681213
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-05
• Primary Completion: 2001-12
• Study Completion: 2002-12
• Study First Submitted: 2008-05-19
• Study First Submitted QC: 2008-05-19
• Study First Posted: 2008-05-21
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Tacrolimus/Sirolimus	Tacrolimus/Sirolimus
C	Neoral/Sirolimus	Neoral/Sirolimus
B	Tacrolimus/MMF	Tacrolimus/MMF

Primary Outcome Measures

Name	Time	Method
Incidence and severity of acute rejection episodes	1 year

Secondary Outcome Measures

Name	Time	Method
1. Graft loss 2. Renal function as determined by serum creatinine and calculated creatinine clearance (using the Cockcroft-Gault method) six and 12 months	1, 3, and 5 years

Trial Locations

Locations (1)

University of Miami Division of Transplantation; 🇺🇸 Miami, Florida, United States