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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00254709
First received: November 11, 2005
Last updated: January 26, 2012
Last verified: January 2012
  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
Endpoint Classification: Safety/Efficacy Study
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
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00254709     History of Changes
Other Study ID Numbers: 0468-100970
Study First Received: November 11, 2005
Last Updated: January 26, 2012
Health Authority: Spain: Spanish Agency of Medicines

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
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014