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, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Study Primary Completion Date: September 2010

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

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

Secondary Measures

• Rejection incidence and severity by Banff '97 Criteria (updated 2005)
  • Time Frame: ongoing
    Safety Issue?: No
• Rejection incidence and severity by treatment and Banff grade
  • Time Frame: ongoing
    Safety Issue?: No
• Patient and allograft survival at 6 and 12 months
  • Time Frame: 6 and 12 months
    Safety Issue?: Yes

• 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

Lead Sponsor: University of Cincinnati

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

Information obtained from ClinicalTrials.gov on September 01, 2010

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