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

NCT00275535 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2011-12-08

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Anti-thymocyte globulin

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

DRUG

Mycophenolate mofetil

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

DRUG

Prednisone

Prednisone 500 mg/day initially, tapered to 5 mg/day by day 92

DRUG

Tacrolimus

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

DRUG

Sirolimus

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

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • Roche Pharma AG

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Mark D. Stegall, M.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-04-30
Primary Completion
2007-11-30
Completion
2008-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00275535 on ClinicalTrials.gov