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

History of Changes

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:

Drug Information available for: Antilymphocyte Serum

U.S. FDA Resources

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
The Christ Hospital
Cincinnati, Ohio, United States, 45202
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267

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 Immunosuppressive Agents Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 01, 2015

To Top