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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 19, 2014