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Completed

NCT Number: NCT00275535

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

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

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Key information

Conditions

Kidney Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anti-thymocyte globulin

Drug

Thymoglobulin 1.5 mg/kg/d (days 0,1,2,4,6)

Other names: Thymoglobulin, Atgam

Mycophenolate mofetil

Drug

Mycophenolate mofetil 750 mg p.o. b.i.d.- maintenance

Other names: CellCept

Prednisone

Drug

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

Tacrolimus

Drug

Tacrolimus - maintain trough levels of 6-8 ng/ml (whole blood Imx assay)

Other names: Prograf, Advagraf, Protopic

sirolimus

Drug

Rapamycin 3 to 5 mg/day; adjust to the high-performance liquid chromatography (HPLC) blood level 15 to 20 ng ml

Other names: Rapamune

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Genzyme, a Sanofi Company
  • Roche Pharma AG
  • Wyeth is now a wholly owned subsidiary of Pfizer

Registry information

Official study title

A Prospective, Randomized Trial of Calcineurin-Inhibitor Withdrawal in Renal Allograft Recipients

Important dates

Study start
2001
Primary completion
2007
Study completion
2008
First posted
Jan 12, 2006
Registry last updated
Dec 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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