Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients

Renal Transplantation Clinical Trial

Official title:

A Randomized, Open-label, Comparative Evaluation of Conversion From Calcineurin Inhibitors to Sirolimus Versus Continued Use of Calcineurin Inhibitors in Renal Allograft Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00038948
• Other study ID #: 0468H1-316
• Status: Completed
• Phase: Phase 3
• First received: June 5, 2002
• Last updated: April 22, 2010
• Start date: January 2002
• Est. completion date: May 2008

Study information

• Verified date: April 2010
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect of conversion from calcineurin inhibitor to sirolimus based therapy on renal function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 830
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

Inclusion Criteria:

• Age greater than or equal to 13 years.

• Receiving CsA or tacrolimus from the time of transplantation or within 2 weeks thereafter

• Patients with a functioning allograft and a Nankivell GFR greater than or equal to 20 mL/min, within 2 weeks before randomization

Exclusion Criteria:

• Biopsy-confirmed acute rejection within 12 weeks before randomization, that was determined to require antirejection treatment

• Patients in whom kidney-pancreas or other multiple organ transplants have been performed

Study Design

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

Related Conditions & MeSH terms

• Renal Transplantation

Intervention

Drug:
• Sirolimus
Sirolimus, Cyclosporine A & Tacrolimus are concentration controlled
• tacrolimus

• Cyclosporine A

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	Nankivell Glomerular Filtration Rate (GFR)	Nankivell GFR: patients with baseline GFR of 20.0 to 40.0 mL/min and patients with baseline GFR of greater than 40.0 mL/min. GFR is an index of kidney function. A higher value means better kidney function.	52 weeks	Yes
Secondary	First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death.	Number of patients who experienced for the first time either biopsy-confirmed acute rejection, graft loss, or death by weeks 52 and 104. Assessed by individual endpoint and as composite endpoint (all combined).	52 and 104 weeks	Yes