The Comparison of Tacrolimus and Sirolimus Immunosuppression Based Drug Regimens in Kidney Transplant Recipients

This study has been completed.
Sponsor:
Collaborators:
Wyeth is now a wholly owned subsidiary of Pfizer
Genzyme, a Sanofi Company
Roche Pharma AG
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00275535
First received: January 10, 2006
Last updated: December 6, 2011
Last verified: December 2011

January 10, 2006
December 6, 2011
April 2001
November 2007   (final data collection date for primary outcome measure)
Glomerular filtration rate (GFR) (iothalamate clearance) at 12 months following transplantation [ Time Frame: 12 months following transplantation ] [ Designated as safety issue: No ]
Glomerular filtration rate (Iothalamate clearance) at 12 months following transplantation.
Glomerular filtration rate (iothalamate clearance) at 12 months following transplantation (expect 20% difference).
Complete list of historical versions of study NCT00275535 on ClinicalTrials.gov Archive Site
  • GFR (iothalamate clearance) at other time points [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Other measures of renal function (serum creatinine, proteinuria and albuminuria) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Acute rejection both early and after tacrolimus withdrawal [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Patient and graft survival [ Time Frame: 24 months after transplantation ] [ Designated as safety issue: No ]
  • Complications-especially hypertension, diabetes, dyslipidemia [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • GFR (iothalamate clearance) at other time points.
  • Other measures of renal function (serum creatine, proteinuria and albuminuria).
  • Acute rejection both early and after tacrolimus withdrawal.
  • Patient and graft survival.
  • Complications-esp. hypertension, diabetes, dyslipidemia.
Not Provided
Not Provided
 
The Comparison of Tacrolimus and Sirolimus Immunosuppression Based Drug Regimens in Kidney Transplant Recipients
A Prospective, Randomized Trial of Calcineurin-Inhibitor Withdrawal in Renal Allograft Recipients

This study was done to find out which treatment, tacrolimus or sirolimus, leads to better long-term kidney function in kidney transplant patients.

The aim of this study was to compare the complete avoidance of calcineurin inhibitors (CI) using a sirolimus-based immunosuppressive regimen to a tacrolimus-based regimen in kidney transplantation. This study was a prospective open-label trial randomizing patients to receive tacrolimus, mycophenolate mofetil and prednisone or sirolimus, mycophenolate mofetil and prednisone. All patients received antithymocyte globulin induction. All rejection episodes were proven by biopsy. The hypothesis was that CI free immunosuppression after kidney transplantation will lead to an increase in glomerular filtration rate (GFR) at one year after kidney transplantation.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Diseases
  • Drug: Anti-thymocyte globulin
    Thymoglobulin 1.5 mg/kg/d (days 0,1,2,4,6)
    Other Names:
    • Thymoglobulin
    • Atgam
  • Drug: Mycophenolate mofetil
    Mycophenolate mofetil 750 mg p.o. b.i.d.- maintenance
    Other Name: CellCept
  • Drug: Prednisone
    Prednisone 500 mg/day initially, tapered to 5 mg/day by day 92
    Other Names:
    • Deltasone
    • Liquid Pred
    • Meticorten
    • Orasone
    • Prednicen-M
    • Prednicot
    • Sterapred
    • Sterapred DS
  • Drug: Tacrolimus
    Tacrolimus - maintain trough levels of 6-8 ng/ml (whole blood Imx assay)
    Other Names:
    • Prograf
    • Advagraf
    • Protopic
  • Drug: Sirolimus
    Rapamycin 3 to 5 mg/day; adjust to the high-performance liquid chromatography (HPLC) blood level 15 to 20 ng ml
    Other Names:
    • Rapamune
    • Sirolimus
  • Active Comparator: Tacrolimus
    Calcineurin inhibitor arm, consisting of treatment with tacrolimus, mycophenolate mofetil, and prednisone.
    Interventions:
    • Drug: Anti-thymocyte globulin
    • Drug: Mycophenolate mofetil
    • Drug: Prednisone
    • Drug: Tacrolimus
  • Active Comparator: Sirolimus
    Calcineurin inhibitor-free arm, consisting of treatment with rapamycin, mycophenolate mofetil, and prednisone.
    Interventions:
    • Drug: Anti-thymocyte globulin
    • Drug: Mycophenolate mofetil
    • Drug: Prednisone
    • Drug: Sirolimus

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
165
December 2008
November 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Living and deceased donor kidney transplant recipients at the Mayo Clinic, Rochester, Minnesota

Exclusion Criteria:

  • Patients with type 1 diabetes less than 50 years of age who receive a living donor kidney transplant followed by a pancreas transplant
  • Pediatric patients (<18 years of age)
  • Multi-organ transplants (e.g., kidney-pancreas, kidney-liver)
  • ABO-incompatible or positive crossmatch recipients (ABO incompatibility is an immune system reaction that occurs when blood from two different and incompatible blood types are mixed together.)
  • Patients with severe hyperlipidemia (serum cholesterol >350 mg/dl or serum triglycerides >500 mg/dl
  • Patients with severe leukopenia (White Blood Cell count [WBC]<3000 10^3/ml)
  • Patients unwilling to return to the transplant center for late follow-up visits
  • Body mass index (BMI) ≥ 32 with incisional problems post transplant (as determined by renal transplant surgeon
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00275535
124-01
Yes
Mark D. Stegall, M.D., Mayo Clinic
Mayo Clinic
  • Wyeth is now a wholly owned subsidiary of Pfizer
  • Genzyme, a Sanofi Company
  • Roche Pharma AG
Principal Investigator: Mark D. Stegall, M.D. Mayo Clinic
Mayo Clinic
December 2011

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