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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00510913

Acronym

CRAF

Enrollment

450

Registered

2007-08-02

Start date

1999-02-28

Completion date

2000-09-30

Last updated

2007-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft Rejection, Kidney Transplantation

Keywords

Treatment efficacy, Transplantation rejection, Kidney transplantation, Cyclosporine, tacrolimus

Brief summary

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

Detailed 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

Interventions

DRUGtacrolimus

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Graft Survival	5 years

Secondary

Measure	Time frame
Patient survival, Graft Loss	5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026