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NCT00273871 Clinical Trial

Study Comparing Conversion From Calcineurin Inhibitors to Rapamune Versus Standard Therapy in Established Renal Allograft Recipients

Kidney Transplantation Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00273871
Other study ID # 0468H1-100535
Secondary ID
Status Completed
Phase Phase 3
First received January 5, 2006
Last updated March 7, 2011
Start date January 2002
Est. completion date September 2006

Study information
Verified date May 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory AgencyIreland: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 190
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Cyclosporin or tacrolimus

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Difference between treatment groups in renal function at 12 months.
Secondary Incidence of acute rejection, patient and graft survival at 12 months, labs and physical examinations, quality of life etc.
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