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Study Evaluating Sirolimus in the Treatment of Kidney Transplant

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. Identifier: NCT00282217
Recruitment Status : Completed
First Posted : January 25, 2006
Last Update Posted : March 22, 2007
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Kidney Failure Kidney Diseases Drug: Sirolimus Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sirolimus in the Treatment of Histological Defined Chronic Allograft Nephropathy
Study Start Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Sirolimus

Primary Outcome Measures :
  1. 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 :
  1. Histological parameters at 12 months
  2. Cumulative incidence of biopsy-confirmed acute rejection at 12 months
  3. Effect at 12 months on proteinuria, blood pressure, hyperlipidemia, and proteinuria

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.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00282217

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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, 28035
Madrid, Spain, 28040
Malaga, Spain, 29010
Oviedo, Spain, 33006
Sevilla, Spain, 41013
Zaragoza, Spain, 50009
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Spain,
Layout table for additonal information Identifier: NCT00282217    
Other Study ID Numbers: 101467
First Posted: January 25, 2006    Key Record Dates
Last Update Posted: March 22, 2007
Last Verified: March 2007
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Kidney Failure
Kidney Transplant
Graft Rejection
Kidney Transplantation
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency
Urologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs