Randomized Trial for Mixed Acute Rejection
This study has been completed.
Sponsor:
University of Cincinnati
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
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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
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 Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013