Effect of Rapid Steroid Withdrawal on Subclinical Markers of Rejection - Article High blood pressure (hypertension)
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
|Kidney Transplantation |
| Drug: Tacrolimus ||Phase IV |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
- 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
- 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
Montreal, Quebec, H1T 2M4, Canada; Recruiting
Medical Monitor, Study Director, Astellas Pharma Canada, Inc.
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
- High Blood Pressure and Kidney Disease (National Institute of Diabetes and Digestive and Kidney Diseases)