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Randomized Trial of Induction Therapies in High Immunological Risk Kidney Transplant Recipients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Millennium Pharmaceuticals, Inc.
Genzyme
Information provided by (Responsible Party):
E. Steve Woodle, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00782821
First received: October 29, 2008
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Kidney Transplantation
 Drug: RATG/Rituxan
Drug: RATG/Velcade
Drug: RATG/Rituxan/Velcade
Drug: Rabbit Antithymocyte Globulin (RATG)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Incidence of acute rejection (Banff '97) or antibody mediated rejection by Banff criteria at 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rejection incidence and severity by Banff '97 Criteria (updated 2005) [ Time Frame: ongoing ] [ Designated as safety issue: No ]
  • Rejection incidence and severity by treatment and Banff grade [ Time Frame: ongoing ] [ Designated as safety issue: No ]
  • Patient and allograft survival at 6 and 12 months [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: September 2008
Estimated Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rabbit Antithymocyte Globulin (RATG)
Rabbit Antithymocyte Globulin (RATG)
 Drug: Rabbit Antithymocyte Globulin (RATG)
RATG
Other Names:
  • Thymoglobulin
  • Rabbit Antithymocyte Globulin
Experimental: RATG/Rituxan
Rabbit Antithymocyte Globulin (RATG)/Rituxan
 Drug: RATG/Rituxan
RATG/Rituxan
Other Names:
  • Thymoglobulin
  • Rituximab
Drug: RATG/Rituxan/Velcade
Rabbit Antithymocyte Globulin (RATG)/ Rituxan/ Velcade
Other Names:
  • Rabbit Antithymocyte Globulin
  • Thymoglobulin
  • Rituximab
  • Velcade
  • bortezomib
Experimental: RATG/Velcade
Rabbit Antithymocyte Globulin (RATG) /Velcade
 Drug: RATG/Rituxan/Velcade
Rabbit Antithymocyte Globulin (RATG)/ Rituxan/ Velcade
Other Names:
  • Rabbit Antithymocyte Globulin
  • Thymoglobulin
  • Rituximab
  • Velcade
  • bortezomib
Experimental: RATG/Rituxan/Velcade
Rabbit Antithymocyte Globulin (RATG) / Rituxan / Velcade
 Drug: RATG/Velcade
RATG/Velcade
Other Names:
  • Thymoglobulin
  • bortezomib

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00782821

Locations
United States, Ohio
The University Hospital
Cincinnati, Ohio, United States, 45219
The Christ Hospital
Cincinnati, Ohio, United States, 45202
Sponsors and Collaborators
University of Cincinnati
Millennium Pharmaceuticals, Inc.
Genzyme
Investigators
Principal Investigator: E. Steve Woodle, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: E. Steve Woodle, MD, FACS, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00782821     History of Changes
Other Study ID Numbers: X05274
Study First Received: October 29, 2008
Last Updated: January 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
Kidney
Renal
Rejection
High risk
Induction
 Immunology
Transplantation
B Cell
Allograft

Additional relevant MeSH terms:
Antilymphocyte Serum
Rituximab
Bortezomib
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
 Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013