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Study Comparing Two Sirolimus Regimens vs. Tacrolimus and Mycophenolate Mofetil Regimen in Kidney Transplant Recipients

This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: December 14, 2005
Last updated: December 18, 2007
Last verified: December 2007
To demonstrate the superiority of SRL + TAC elimination + corticosteroids (Group I) and SRL + MMF + corticosteroids (Group II) to TAC + MMF + corticosteroids (Group III) with respect to renal allograft function at month 12 post-transplantation.

Condition Intervention Phase
Graft Rejection
Kidney Failure
Kidney Transplant
Drug: Sirolimus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Open-Label Study to Compare the Safety and Efficacy of Two Different Sirolimus Regimens With a Tacrolimus + Mycophenolate Mofetil Regimen in De Novo Renal Allograft Recipients

Resource links provided by NLM:

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Kidney function at 52 weeks after transplantation.

Secondary Outcome Measures:
  • Kidney function at 26, 78 and 104 weeks after transplantation

Estimated Enrollment: 420
Study Start Date: March 2004
Study Completion Date: July 2007

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 18 years.
  • End-stage renal disease with subjects scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated mismatched donor, or from a living-related mismatched donor. Unreported HLA values will be considered a match.
  • Women of childbearing potential must have a negative serum pregnancy test before administration of assigned treatment and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of assigned treatment.

Other inclusions apply.

Exclusion Criteria:

  • Evidence of active systemic or localized major infection.
  • Known hypersensitivity to SRL or its derivatives, macrolide antibiotics, corticosteroids, TAC or MMF.
  • Multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant).

Other exclusions apply.

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Please refer to this study by its identifier: NCT00266123

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth Reseach
Principal Investigator: Trial Manager For Belgium,
Principal Investigator: Trial Manager For France,
Principal Investigator: Trial Manager For Germany,
Principal Investigator: Trial Manager For Italy,
Principal Investigator: Trial Manager For Poland,
Principal Investigator: Trial Manager For Spain,
Principal Investigator: Trial Manager For Switzerland,
Principal Investigator: Trial Manager For United Kingdom,
  More Information Identifier: NCT00266123     History of Changes
Other Study ID Numbers: 0468H1-101497
Study First Received: December 14, 2005
Last Updated: December 18, 2007

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Kidney Failure
Kidney Transplant

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents processed this record on May 22, 2017