We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Comparing Conversion From Calcineurin Inhibitors to Rapamune Versus Standard Therapy in Established Renal Allograft 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: NCT00273871
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : March 8, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of the study is to determine the effect of conversion from calcineurin inhibitor based therapy to Rapamune based therapy in patients with mild to moderate renal insufficiency.

Condition or disease Intervention/treatment Phase
Graft Rejection Kidney Failure Kidney Transplantation Drug: Cyclosporin or tacrolimus Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-centre, Randomized, Open-label, Study to Compare Conversion From Calcineurin Inhibitors to Rapamune Versus Standard Therapy in Established Renal Allograft Recipients on Maintenance Therapy With Mild to Moderate Renal Insufficiency.
Study Start Date : January 2002
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Difference between treatment groups in renal function at 12 months.

Secondary Outcome Measures :
  1. Incidence of acute rejection, patient and graft survival at 12 months, labs and physical examinations, quality of life etc.

Eligibility Criteria

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

Inclusion Criteria:

  • Age over 18
  • Treatment with a calcineurin inhibitor
  • Patients with mild to moderate renal insufficiency

Exclusion Criteria:

  • Patients with acute rejection
  • Patients who received a transplant more than 10 years ago
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): NCT00273871


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 United Kingdom and Ireland, ukmedinfo@wyeth.com
More Information

ClinicalTrials.gov Identifier: NCT00273871     History of Changes
Other Study ID Numbers: 0468H1-100535
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: March 8, 2011
Last Verified: May 2007

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

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Tacrolimus
Cyclosporins
Cyclosporine
Sirolimus
Calcineurin Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antineoplastic Agents