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

NCT00275535

Last updated date
Study Location
Mayo Clinic
Rochester, Minnesota, 55905, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Kidney Diseases
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Kidney DiseasesThe Comparison of Tacrolimus and Sirolimus Immunosuppression Based Drug Regimens in Kidney Transplant Recipients
NCT00275535
  1. Rochester, Minnesota
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Advanced Information
Descriptive Information
Brief Title  ICMJE The Comparison of Tacrolimus and Sirolimus Immunosuppression Based Drug Regimens in Kidney Transplant Recipients
Official Title  ICMJE A Prospective, Randomized Trial of Calcineurin-Inhibitor Withdrawal in Renal Allograft Recipients
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Kidney Diseases
Intervention  ICMJE
  • 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 Name: Rapamune
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2011)
165
Original Enrollment  ICMJE
 (submitted: January 10, 2006)
100
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00275535
Other Study ID Numbers  ICMJE 124-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mark D. Stegall, M.D., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE
  • Wyeth is now a wholly owned subsidiary of Pfizer
  • Genzyme, a Sanofi Company
  • Roche Pharma AG
Investigators  ICMJE
Principal Investigator:Mark D. Stegall, M.D.Mayo Clinic
PRS Account Mayo Clinic
Verification Date December 2011

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