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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00254709
First Posted: November 16, 2005
Last Update Posted: January 31, 2012
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.
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
  Purpose
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 Aged Drug: Sirolimus Phase 4

Study Type: Interventional
Study Design: 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

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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Investigators
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 Submitted: November 11, 2005
First Posted: November 16, 2005
Last Update Posted: January 31, 2012
Last Verified: January 2012

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

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs