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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00681213
Recruitment Status : Completed
First Posted : May 21, 2008
Last Update Posted : May 29, 2008
Wyeth-Ayesrst Pharmaceuticals, Roche Laboratories, and Fujusawa Healthcare, Inc.
Information provided by:
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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2000
Actual Primary Completion Date : December 2001
Actual Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Drug: Tacrolimus/Sirolimus
Experimental: B
Drug: Tacrolimus/MMF
Experimental: C
Drug: Neoral/Sirolimus

Primary Outcome Measures :
  1. Incidence and severity of acute rejection episodes [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00681213

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.

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. George W. Burke, University of Miami Identifier: NCT00681213     History of Changes
Other Study ID Numbers: IRB#19990664
First Posted: May 21, 2008    Key Record Dates
Last Update Posted: May 29, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Dermatologic Agents
Antirheumatic Agents