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

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ClinicalTrials.gov Identifier: NCT00275535
Recruitment Status : Completed
First Posted : January 12, 2006
Last Update Posted : December 8, 2011
Sponsor:
Collaborators:
Wyeth is now a wholly owned subsidiary of Pfizer
Genzyme, a Sanofi Company
Roche Pharma AG
Information provided by:
Mayo Clinic

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

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Trial of Calcineurin-Inhibitor Withdrawal in Renal Allograft Recipients
Study Start Date : April 2001
Actual Primary Completion Date : November 2007
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: Rapamune




Primary Outcome Measures :
  1. Glomerular filtration rate (GFR) (iothalamate clearance) at 12 months following transplantation [ Time Frame: 12 months following transplantation ]
    Glomerular filtration rate (Iothalamate clearance) at 12 months following transplantation.


Secondary Outcome Measures :
  1. GFR (iothalamate clearance) at other time points [ Time Frame: 24 months ]
  2. Other measures of renal function (serum creatinine, proteinuria and albuminuria) [ Time Frame: 24 months ]
  3. Acute rejection both early and after tacrolimus withdrawal [ Time Frame: 24 months ]
  4. Patient and graft survival [ Time Frame: 24 months after transplantation ]
  5. Complications-especially hypertension, diabetes, dyslipidemia [ Time Frame: 24 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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, a Sanofi Company
Roche Pharma AG
Investigators
Principal Investigator: Mark D. Stegall, M.D. Mayo Clinic

Additional Information:
Publications of Results:
Responsible Party: Mark D. Stegall, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00275535     History of Changes
Other Study ID Numbers: 124-01
First Posted: January 12, 2006    Key Record Dates
Last Update Posted: December 8, 2011
Last Verified: December 2011

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

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