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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

May 19, 2008
May 23, 2008
May 2000
December 2001   (final data collection date for primary outcome measure)
Incidence and severity of acute rejection episodes [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00681213 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Tacrolimus/Sirolimus Versus Tacrolimus/Mycophenolate Mofetil (MMF) Versus Neoral/Sirolimus in Adult, Primary Kidney Transplantation
Tacrolimus and Mycophenolate Versus Tacrolimus and Sirolimus vs. Neoral and Sirolimus Used in Combination in Cadaver and Non-HLA Identical Living Related Kidney Transplants

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Adult Primary Kidney Transplantation
  • Drug: Tacrolimus/Sirolimus
  • Drug: Tacrolimus/MMF
  • Drug: Neoral/Sirolimus
  • Experimental: A
    Tacrolimus/Sirolimus
    Intervention: Drug: Tacrolimus/Sirolimus
  • Experimental: B
    Tacrolimus/MMF
    Intervention: Drug: Tacrolimus/MMF
  • Experimental: C
    Neoral/Sirolimus
    Intervention: Drug: Neoral/Sirolimus

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
December 2002
December 2001   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00681213
IRB#19990664
Yes
Dr. George W. Burke, University of Miami
University of Miami
Wyeth-Ayesrst Pharmaceuticals, Roche Laboratories, and Fujusawa Healthcare, Inc.
Not Provided
University of Miami
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP