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

Kidney Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00254709
• Other study ID #: 0468-100970
• Status: Completed
• Phase: Phase 4
• First received: November 11, 2005
• Last updated: January 26, 2012
• Start date: October 2002
• Est. completion date: September 2005

Study information

• Verified date: January 2012
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test two different sirolimus-based immunosuppressive regimens for elderly kidney transplant recipients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Aged
• Graft Rejection
• Kidney Failure
• Renal Insufficiency

Intervention

Drug:
• Sirolimus

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	Renal function at 3 and 12 months; measured by Cockroft-Gault formula or serum creatinine
Secondary	Incidence of acute rejections at 3 and 12 months
Secondary	Patient and graft survival at 3 and 12 months
Secondary	Incidence and duration of episodes of acute tubular necrosis
Secondary	Time to recover renal function (creatinine< 2 mg/dl)