Randomized Trial of Induction Therapies in High Immunological Risk Kidney Transplant Recipients
The purpose of this research study is to find out the effects of adding B lymphocyte modulating agents in patients at risk for rejection receiving an anti-rejection (immunosuppressive) regimen of Thymoglobulin® induction with Prograf®, Cellcept® and corticosteroid therapy...
Brief Summary
Official Title: “Targeted Therapy for High Immunologic Risk Renal Transplant Recipients: A Prospective, Randomized, Open-Label Pilot Study of B-Cell Depleting Therapy in Combination With Anti-Thymocyte Globulin [Rabbit] (Thymoglobulin®, Genzyme), Tacrolimus (Prograf®, Astellas), Mycophenolate Mofetil (CellCept®, Roche) and Corticosteroid Minimization”
The purpose of this research study is to find out the effects of adding B lymphocyte modulating agents in patients at risk for rejection receiving an anti-rejection (immunosuppressive) regimen of Thymoglobulin® induction with Prograf®, Cellcept® and corticosteroid therapy.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
- Study Primary Completion Date: September 2011
Intervention(s) in this Clinical Trial
- Drug: RATG/Hi Dose B cell depletion
- RATG/Hi Dose B cell depletion
- Drug: RATG/Lo Dose B cell depletion
- RATG/Lo Dose B cell depletion
- Drug: RATG/ASC depletion
- RATG/ASC depletion
- Drug: RATG
- RATG
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: RATG
- Experimental: RATG/Hi Dose B cell depletion
- Experimental: RATG /ASC depletion
- Experimental: RATG/Lo Dose B cell depletion
Outcome Measures for this Clinical Trial
Primary Measures
- Incidence of acute rejection (Banff '97) or antibody mediated rejection by Banff criteria at 6 months.
- Time Frame: 6 months
Safety Issue?: No
- Time Frame: 6 months
Secondary Measures
- Rejection incidence and severity by Banff '97 Criteria (updated 2005)
- Time Frame: ongoing
Safety Issue?: No
- Time Frame: ongoing
- Rejection incidence and severity by treatment and Banff grade
- Time Frame: ongoing
Safety Issue?: No
- Time Frame: ongoing
- Patient and allograft survival at 6 and 12 months
- Time Frame: 6 and 12 months
Safety Issue?: Yes
- Time Frame: 6 and 12 months
Criteria for Participation in this Clinical Trial
- Patient has been fully informed and has signed IRB approved informed consent and is willing and able to follow study procedures
- Patient is considered at high risk for acute rejection by predefined criteria in the detailed IRB approved protocol
- Women of childbearing potential must use two reliable forms of contraception
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: University of Cincinnati Other
Overall Clinical Trial Officials and Contacts
E. Steve Woodle, MD Principal Investigator University of Cincinnati
Overall Contact: Garth E Wall, BS 513-558-0289 garth.wall@uc.edu
Additional Information
Information obtained from ClinicalTrials.gov on February 02, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00782821
Study ID Number: X05274
ClinicalTrials.gov Identifier: NCT00782821
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00782821
