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OpenTrials
Completed

NCT Number: NCT00510913

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

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

Completed

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Los Angeles, California, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus

Drug

Other names: Prograf®, FK506

Primary outcomes

  1. Graft Survival

    Time frame: 5 years

Secondary outcomes

  1. Patient survival, Graft Loss

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

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

Acronym: CRAF

Important dates

Study start
1999
Study completion
2000
First posted
Aug 2, 2007
Registry last updated
Aug 2, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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