A Study to Compare the Conversion to Prograf® (Tacrolimus) to the Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure

Kidney Transplantation Clinical Trial

— CRAF  

Official title:

Prograf® (Tacrolimus) as Secondary Intervention vs. Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00510913
• Other study ID #: 20-98-002
• Status: Completed
• Phase: Phase 4
• First received: July 31, 2007
• Last updated: July 31, 2007
• Start date: February 1999
• Est. completion date: September 2000

Study information

• Verified date: July 2007
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

A study to compare the conversion to Prograf® (tacrolimus) to the continuation of cyclosporine in patients at risk for chronic renal allograft failure

Description:

A two arm study (1 Active, 1 Active control) to compare the incidence, progression and severity of chronic renal allograft failure in at-risk patients who are converted from cyclosporine-based to tacrolimus-based immunosuppression to patients who remain on cyclosporine-based therapy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: September 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Patient has been on cyclosporine-based immunosuppression regimen since the transplant

• Patient has at least one pre-defined risk factor for chronic allograft failure

Exclusion Criteria:

• Patient is dialysis dependent

• Patient is recipient of a solid organ transplant other than the kidney

Study Design

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

Related Conditions & MeSH terms

• Graft Rejection
• Kidney Transplantation

Intervention

Drug:
• tacrolimus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft Survival		5 years
Secondary	Patient survival, Graft Loss		5 years