Randomized Trial for Mixed Acute Rejection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
E. Steve Woodle, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00771875
First received: October 14, 2008
Last updated: March 15, 2013
Last verified: March 2013
  Purpose

This study is being conducted to determine how safe and effective using an immune cell (b cell) depleting therapy and/or Thymoglobulin is in patients with a kidney transplant who are experiencing certain types of rejection.


Condition Intervention Phase
Graft Rejection
Drug: Rabbit Antithymocyte Globulin (RATG)
Drug: Rabbit Antithymocyte Globulin (RATG)/B cell depletion
Drug: Rabbit Antithymocyte Globulin (RATG)/ASC depletion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: B-Cell Targeted Therapy for Acute Renal Allograft Rejection With an Antibody Mediated Component: A Prospective, Randomized, Open-Label Study

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Proportion of patients in each group with any of the following: Rejection reversal or Recurrent rejection [ Time Frame: undefined ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of allografts that lack C4d deposition in peritubular capillary on follow-up biopsy [ Time Frame: undefined ] [ Designated as safety issue: No ]
  • Renal allograft function as determined by change (∆) in Serum creatinine at 7, 14, 28, 60, and 90 days post therapy initiation [ Time Frame: 7, 14, 28, 60, 90 days ] [ Designated as safety issue: No ]
  • Renal allograft function as determined by change (∆) in Calculated creatinine clearance by Cockcroft-Gault at 7, 14, 28, 60, and 90 days post therapy initiation [ Time Frame: 7, 14, 28, 60, 90 days ] [ Designated as safety issue: No ]
  • Renal allograft function as determined by change (∆) in Urine protein: Urine Creatinine ratio at 28 and 90 days post therapy initiation [ Time Frame: 28, 90 days ] [ Designated as safety issue: No ]
  • Incidence of acute rejection, graft loss, hospitalization due to infection, and death at 3 months (90 days) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: September 2008
Study Completion Date: March 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rabbit Antithymocyte Globulin (RATG)
RATG
Drug: Rabbit Antithymocyte Globulin (RATG)
RATG
Experimental: Rabbit Antithymocyte Globulin (RATG)/B cell depletion
RATG/B cell depletion
Drug: Rabbit Antithymocyte Globulin (RATG)/B cell depletion
RATG/B cell depletion
Experimental: Rabbit Antithymocyte Globulin (RATG)/ASC depletion
RATG/ASC depletion
Drug: Rabbit Antithymocyte Globulin (RATG)/ASC depletion
RATG/ASC depletion

Detailed Description:

The purpose of the study is to determine safety and efficacy of treatment if mixed (cellular and antibody) mediated acute rejection with addition of B-cell depleting therapy to Thymoglobulin in kidney and simultaneous kidney pancreas allograft recipients.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Deceased or living donor transplant recipients with mixed acute rejection.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771875

Locations
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
The Christ Hospital
Cincinnati, Ohio, United States, 45202
Sponsors and Collaborators
University of Cincinnati
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: NCT00771875     History of Changes
Other Study ID Numbers: X05273
Study First Received: October 14, 2008
Last Updated: March 15, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Antilymphocyte Serum
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

ClinicalTrials.gov processed this record on August 18, 2014