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Study Evaluating Sirolimus in the Treatment of Kidney Transplant

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00282217
First received: January 24, 2006
Last updated: March 21, 2007
Last verified: March 2007
History of Changes
  Purpose

The aim of this study is to test whether withdrawal of calcineurin inhibitors, followed by treatment with sirolimus, may improve renal function in renal transplant recipients with chronic allograft nephropathy.


Condition Intervention Phase
Kidney Failure
Kidney Diseases
 Drug: Sirolimus
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sirolimus in the Treatment of Histological Defined Chronic Allograft Nephropathy

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Renal function at 12 months; Comparison between slopes of glomerular filtration rate (GFR) of one year before versus one year after start on sirolimus

Secondary Outcome Measures:
  • Histological parameters at 12 months
  • Cumulative incidence of biopsy-confirmed acute rejection at 12 months
  • Effect at 12 months on proteinuria, blood pressure, hyperlipidemia, and proteinuria

Estimated Enrollment: 100
Study Start Date: August 2006
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Renal transplantation
  • Biopsy-confirmed chronic rejection
  • Treatment with mofetil mycophenolate among cyclosporine or tacrolimus

Exclusion Criteria:

  • Transplant of any organ other than the kidney
  • Current important infection
  • Acute rejection within 12 weeks prior to inclusion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00282217

Locations
Spain
Albacete, Spain, 2006
Barcelona, Spain, 8035
Cadiz, Spain, 11009
Granada, Spain, 18014
L'Hospitalet de Llobregat, Spain, 8701
La Coruna, Spain, 15006
Madrid, Spain, 28034
Madrid, Spain, 28040
Madrid, Spain, 28035
Malaga, Spain, 29010
Oviedo, Spain, 33006
Sevilla, Spain, 41013
Zaragoza, Spain, 50009
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
Principal Investigator: Trial Manager For Spain, infomed@wyeth.com
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00282217     History of Changes
Other Study ID Numbers: 101467
Study First Received: January 24, 2006
Last Updated: March 21, 2007
Health Authority: Spain: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 19, 2013