Randomized Trial of Induction Therapies in High Immunological Risk Kidney Transplant Recipients
Information source: University of Cincinnati
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Transplantation
Intervention: RATG/Hi Dose B cell depletion (Drug); RATG/Lo Dose B cell depletion (Drug); RATG/ASC depletion (Drug); RATG (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Cincinnati Official(s) and/or principal investigator(s):
E. Steve Woodle, MD, Principal Investigator, Affiliation: University of Cincinnati
Overall contact:
Garth E Wall, BS, Phone: 513-558-0289, Email: garth.wall@uc.edu
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Incidence of acute rejection (Banff '97) or antibody mediated rejection by Banff criteria at 6 months.
Secondary outcome: Rejection incidence and severity by Banff '97 Criteria (updated 2005)Rejection incidence and severity by treatment and Banff grade Patient and allograft survival at 6 and 12 months
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
- 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
Locations and Contacts
Garth E Wall, BS, Phone: 513-558-0289, Email: garth.wall@uc.edu
The University Hospital, Cincinnati, Ohio 45219, United States; Recruiting
Garth` Wall, Phone: 513-585-0016
E. Steve Woodle, MD, Principal Investigator
The Christ Hospital, Cincinnati, Ohio 45202, United States; Recruiting
Adele Rike, PharmD, Phone: 513-585-2439
E. Steve Woodle, MD, Principal Investigator
Additional Information
Starting date: September 2008
Last updated: November 5, 2010
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