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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
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
History of Changes
  Purpose

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


Condition Intervention Phase
Kidney Diseases
 Drug: Anti-thymocyte globulin
Drug: Mycophenolate mofetil
Drug: Prednisone
Drug: Tacrolimus
Drug: Sirolimus
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Trial of Calcineurin-Inhibitor Withdrawal in Renal Allograft Recipients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 165
Study Start Date: April 2001
Study Completion Date: December 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tacrolimus
Calcineurin inhibitor arm, consisting of treatment with tacrolimus, mycophenolate mofetil, and prednisone.
 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
Active Comparator: Sirolimus
Calcineurin inhibitor-free arm, consisting of treatment with rapamycin, mycophenolate mofetil, and prednisone.
 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: 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00275535

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Wyeth is now a wholly owned subsidiary of Pfizer
Genzyme
Roche Pharma AG
Investigators
Principal Investigator: Mark D. Stegall, M.D. Mayo Clinic
  More Information

Additional Information:
Mayo Clinic Clinical Trials  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Mark D. Stegall, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00275535     History of Changes
Other Study ID Numbers: 124-01
Study First Received: January 10, 2006
Last Updated: December 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
kidney transplantation
immunosuppression
calcineurin inhibitor
sirolimus
chronic allograft nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Antilymphocyte Serum
Mycophenolate mofetil
Sirolimus
Everolimus
Tacrolimus
Mycophenolic Acid
Prednisone
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
 Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Anti-Inflammatory Agents
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 21, 2013