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

This study has been completed.
Sponsor:
Collaborator:
Wyeth-Ayesrst Pharmaceuticals, Roche Laboratories, and Fujusawa Healthcare, Inc.
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT00681213
First received: May 19, 2008
Last updated: May 23, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Adult Primary Kidney Transplantation
Drug: Tacrolimus/Sirolimus
Drug: Tacrolimus/MMF
Drug: Neoral/Sirolimus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tacrolimus and Mycophenolate Versus Tacrolimus and Sirolimus vs. Neoral and Sirolimus Used in Combination in Cadaver and Non-HLA Identical Living Related Kidney Transplants

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Incidence and severity of acute rejection episodes [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 1. Graft loss 2. Renal function as determined by serum creatinine and calculated creatinine clearance (using the Cockcroft-Gault method) six and 12 months [ Time Frame: 1, 3, and 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: May 2000
Study Completion Date: December 2002
Primary Completion Date: December 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Tacrolimus/Sirolimus
Drug: Tacrolimus/Sirolimus
Experimental: B
Tacrolimus/MMF
Drug: Tacrolimus/MMF
Experimental: C
Neoral/Sirolimus
Drug: Neoral/Sirolimus

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681213

Locations
United States, Florida
University of Miami Division of Transplantation
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Wyeth-Ayesrst Pharmaceuticals, Roche Laboratories, and Fujusawa Healthcare, Inc.
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. George W. Burke, University of Miami
ClinicalTrials.gov Identifier: NCT00681213     History of Changes
Other Study ID Numbers: IRB#19990664
Study First Received: May 19, 2008
Last Updated: May 23, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Mycophenolic Acid
Mycophenolate mofetil
Sirolimus
Everolimus
Tacrolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 20, 2014