Clinical trial NCT00637143: Tacrolimus as Secondary Intervention vs. Continuation of Cyclosporine in Renal Transplant Patients With Chronic Renal Allograft Failure (CRAF)
Official title: Prograf® (Tacrolimus) as Secondary Intervention vs. Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Transplantation
Chronic Renal Allograft Failure
Keywords: Renal transplant
Cyclosporine
Tacrolimus
Intervention
Interstitial Fibrosis Tubular Atrophy
Chronic Renal Allograft Failure
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Canada, Inc.
First posted: 2008-03-17
Enrollment: 107
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Graft Survival
timeFrame: 5 years
Secondary outcomes:
measure: Patient Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: St. Johns
country: Canada
state: Newfoundland and Labrador
city: Halifax
country: Canada
state: Nova Scotia
city: Hamilton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
Study officials:
affiliation: Astellas Pharma Canada, Inc.
name: Central Contact
role: STUDY_CHAIR
References:
citation: 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.