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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00254709
Recruitment Status : Completed
First Posted : November 16, 2005
Last Update Posted : January 31, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to test two different sirolimus-based immunosuppressive regimens for elderly kidney transplant recipients.

Condition or disease Intervention/treatment Phase
Kidney Failure Graft Rejection Aged Drug: Sirolimus Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2002
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT00254709     History of Changes
Other Study ID Numbers: 0468-100970
First Posted: November 16, 2005    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 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