Clinical Trial: Effect of Rapid Steroid Withdrawal on Subclinical Markers of Rejection

This study is currently recruiting patients.
Verified by Astellas Pharma US, Inc. August 2005

Sponsored by: Astellas Pharma Canada, Inc.
Information provided by: Astellas Pharma US, Inc.
ClinicalTrials.gov Identifier: NCT00133172

Purpose

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
Condition Intervention Phase
Kidney Transplantation
Renal Transplantation
Transplantation, Renal
Transplantation, Kidney
Grafting, Kidney
 Drug: Tacrolimus
Phase IV

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

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 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 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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00133172

Astellas Pharma Canada Medical Information      1-888-338-1824 

Canada, Quebec
      Montreal,  Quebec,  H1T 2M4,  Canada; Recruiting
Medical Information, 1-888-338-1824

Study chairs or principal investigators

Medical Monitor,  Study Director,  Astellas Pharma Canada, Inc.   

More Information

Study ID Numbers:  FKC-011
Last Updated:  August 22, 2005
Record first received:  August 22, 2005
ClinicalTrials.gov Identifier:  NCT00133172
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-08-23

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