Study Evaluating Sirolimus in the Treatment of Kidney Transplant

Kidney Diseases Clinical Trial

Official title:

Sirolimus in the Treatment of Histological Defined Chronic Allograft Nephropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00282217
• Other study ID #: 101467
• Status: Completed
• Phase: Phase 4
• First received: January 24, 2006
• Last updated: March 21, 2007
• Start date: August 2006

Study information

• Verified date: March 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Diseases
• 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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Histological parameters at 12 months
Secondary	Cumulative incidence of biopsy-confirmed acute rejection at 12 months
Secondary	Effect at 12 months on proteinuria, blood pressure, hyperlipidemia, and proteinuria