Effect of Rapid Steroid Withdrawal on Subclinical Markers of Rejection

Phase 4

Terminated

• Conditions: Kidney Transplantation
• Interventions: Drug: Tacrolimus; Drug: mycophenolate mofetil; Drug: Prednisone

• Registration Number: NCT00133172
• Lead Sponsor: Astellas Pharma Inc

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-08-22
• Study First Submitted QC: 2005-08-22
• Study First Posted: 2005-08-23
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-05
• Last Update Posted: 2014-09-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 85

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	mycophenolate mofetil	Steroid rapid 5-day withdrawal
1	Tacrolimus	Steroid rapid 5-day withdrawal
2	Tacrolimus	Standard steroid maintenance
2	mycophenolate mofetil	Standard steroid maintenance
2	Prednisone	Standard steroid maintenance
1	Prednisone	Steroid rapid 5-day withdrawal

Primary Outcome Measures

Name	Time	Method
Combined incidence of biopsy proven subclinical rejection (BPSCR) and biopsy proven clinical acute rejection (BPCAR)	3 months post transplant

Secondary Outcome Measures

Name	Time	Method
Biopsy proven chronic allograft nephropathy(CAN)	2 years post transplant
Patient and graft survival rates	End of study (5 years)