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Study Evaluating Two Different Sirolimus-based Immunosuppressive Regimens in Elderly Kidney Transplant Recipients

This study has been completed.
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: November 11, 2005
Last updated: January 26, 2012
Last verified: January 2012
The purpose of this study is to test two different sirolimus-based immunosuppressive regimens for elderly kidney transplant recipients.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open, Pilot, Comparative Study to Evaluate the Efficacy and Safety of Two Immunosuppressor Regimens, Anti Il-2, Sirolimus Mycophenolate, Mophetyl and Steroids Versus Sirolimus, Cyclosporine, and Withdrawal of Cyclosporine Since the Third Month and Steroids in Elderly Population

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Renal function at 3 and 12 months; measured by Cockroft-Gault formula or serum creatinine

Secondary Outcome Measures:
  • Incidence of acute rejections at 3 and 12 months
  • Patient and graft survival at 3 and 12 months
  • Incidence and duration of episodes of acute tubular necrosis
  • Time to recover renal function (creatinine< 2 mg/dl)

Enrollment: 66
Study Start Date: October 2002
Study Completion Date: September 2005

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • End stage renal disease
  • Kidney transplantation
  • Both donor and recipient older than 60 years

Exclusion Criteria:

  • Prior or concurrent transplant of any organ other than the kidney
  • Current clinically significant infections
  Contacts and Locations
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Please refer to this study by its identifier: NCT00254709

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer Identifier: NCT00254709     History of Changes
Other Study ID Numbers: 0468-100970
Study First Received: November 11, 2005
Last Updated: January 26, 2012

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
kidney transplant

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017