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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00133172
Other study ID # FKC-011
Secondary ID
Status Terminated
Phase Phase 4
First received August 22, 2005
Last updated September 5, 2014
Start date July 2005
Est. completion date March 2007

Study information

Verified date September 2014
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the safety and efficacy of a tacrolimus-based 5-day steroid rapid withdrawal immunoprophylactic regimen in de novo renal transplantation.


Recruitment information / eligibility

Status Terminated
Enrollment 85
Est. completion date March 2007
Est. primary completion date March 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subject or legally acceptable guardian has signed and dated a Research Ethics Board (REB)-approved informed consent form and is willing and able to follow study procedures.

- Subject is the recipient of a first or second cadaveric or living donor mismatched (at least one mismatch) renal transplant.

- Subject is 18 years of age or over at the time of transplant.

- If female and of child-bearing potential, subject has a negative pregnancy test and utilizes adequate contraceptive methods

Exclusion Criteria:

- Recipients of a kidney from a donor 60 years of age or older

- Recipients of donation after cardiac death (DCD) donors

- Recipients of a combined transplant (e.g. kidney-pancreas, -lung, -heart)

- Subjects with a second renal allograft who had their original graft for < 2 years, unless the initial graft was lost in the early (1 year or less) post transplant course due to a technical or surgical failure

- Subjects with a current/latest pre-transplant panel of reactive antibodies (PRA) >20

- Subjects with hepatitis B & C, HIV or cancer (excluding successfully excised squamous or basal cell carcinoma)

- Subjects receiving an allograft with cold ischemia time 24 hours or greater

- Subjects who have received an investigational drug within three months prior to randomization

- Subjects who are breastfeeding

- Subjects with known hypersensitivity to tacrolimus, mycophenolate mofetil, methylprednisolone, basiliximab, prednisone, or any related drugs or their excipients

- Subjects with significant disease (e.g. uncontrolled infection) or disability (e.g. cognitive deficit) that prevents understanding of or adherence to the protocol

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Tacrolimus
IV
mycophenolate mofetil
IV
Prednisone
IV

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, 

Outcome

Type Measure Description Time frame Safety issue
Primary Combined incidence of biopsy proven subclinical rejection (BPSCR) and biopsy proven clinical acute rejection (BPCAR) 3 months post transplant No
Secondary Biopsy proven chronic allograft nephropathy(CAN) 2 years post transplant No
Secondary Patient and graft survival rates End of study (5 years) No
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