Effect of Rapid Steroid Withdrawal on Subclinical Markers of Rejection

Kidney Transplantation Clinical Trial

Official title:

Evaluation of the Long-term Safety and Efficacy of a Tacrolimus-based 5-day Steroid Rapid Withdrawal Immunoprophylactic Regimen in de Novo Renal Transplantation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00133172
• Other study ID #: FKC-011
• 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

• Kidney Transplantation

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

External Links

•   Link to Results on JAPIC - enter 140581 in the JapicCTI-RNo. field