Tacrolimus as Secondary Intervention vs. Continuation of Cyclosporine in Renal Transplant Patients With Chronic Renal Allograft Failure (CRAF)

Renal Transplantation Clinical Trial

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: NCT00637143
• Other study ID #: FKC-003
• Status: Completed
• Phase: Phase 4
• First received: March 10, 2008
• Last updated: February 15, 2017
• Start date: April 1999
• Est. completion date: February 2006

Study information

• Verified date: February 2017
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare renal transplant recipients on cyclosporine maintenance therapy vs. those converted to tacrolimus-based immunosuppression with respect to renal outcomes.

Description:

The objective of this study is to compare the incidence, progression and severity of chronic renal allograft failure in at-risk patients who are converted from cyclosporine to tacrolimus-based immunosuppression to patients who remain on cyclosporine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Patient is at least 3 months post-transplant of a cadaveric or living donor kidney

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

• Patient has one of the following risk factors for chronic renal allograft failure at the baseline biopsy:

• Serum creatinine: Male: >=2.0mg/dL (176.8 umol/L); Female: >= 1.7mg/dL (150.28 umol/L) 3 months or later post-transplant

• Serum creatinine > 30% increased over post-discharge nadir

• Patient has had a renal biopsy > 3 months after transplant and within 6 months prior to enrollment

• Patient or legal guardian has signed and dated an IRB approved informed consent document

• Female patient has a negative pregnancy test and agrees to practice effective birth control while receiving mycophenolate mofetil (MMF)

Exclusion Criteria:

• Patient is dialysis dependent and has recurrence of primary or de novo renal disease

• Patient has an estimated creatinine clearance <25mL/min

• Patient has changed maintenance immunosuppressant therapy (e.g., azathioprine to MMF) within 3 months of randomization

• Baseline biopsy shows acute rejection Grade >=IIB using Banff 95 criteria or >= Grade IIA using Banff 97 criteria

• Patient requires antilymphocyte therapy to treat rejection at baseline or post-baseline biopsy

• Patient has received an investigational immunosuppressant within 3 months, or has a known hypersensitivity to tacrolimus, or any excipients of the drug

• Patient is a known carrier of any of the HIV viruses

Related Conditions & MeSH terms

• Chronic Renal Allograft Failure
• Renal Transplantation

Intervention

Drug:
• Tacrolimus
Oral
• Cyclosporine
Oral

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma Canada, Inc.

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Jevnikar A, Arlen D, Barrett B, Boucher A, Cardella C, Cockfield SM, Rush D, Paraskevas S, Shapiro J, Shoker A, Yilmaz S, Zaltzman JS, Kiberd B. Five-year study of tacrolimus as secondary intervention versus continuation of cyclosporine in renal transplant patients at risk for chronic renal allograft failure. Transplantation. 2008 Oct 15;86(7):953-60. doi: 10.1097/TP.0b013e318186dd0c. — View Citation

Outcome

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

External Links

•   Link to results on Astellas Clinical Study Results website