Status:
UNKNOWN
Evaluating Safety and Efficacy of TOL101 Induction Versus Anti-Thymocyte Globulin to Prevent Kidney Transplant Rejection
Lead Sponsor:
Tolera Therapeutics, Inc
Conditions:
End Stage Renal Disease
Renal Transplant
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
Induction therapy with antibodies is administered during transplant surgery and for a short period of time following transplant surgery in an effort to render the immune system less able to mount an i...
Eligibility Criteria
Inclusion
- Recipient of a primary renal transplant from a living or standard criteria cadaveric donor
- Male or female 18-60 years of age
- Recipient with a PRA \< 20%
Exclusion
- Previous solid organ transplant
- Recipient of HLA-identical kidney allograft transplant
- Recipient of an ABO incompatible donor kidney
- Known HIV infection or other major infection
- History of malignancy within 3 years (excluding treated basal cell or squamous cell carcinoma of the skin) prior to enrollment
- History of tuberculosis
- Recipient with cardiovascular disease
- Treatment with immunosuppressive medications within 1 month prior to enrollment
- Known or suspected allergy to mice
- Pregnant or lactating
- Unable or unwilling to participate in all required study activities for the duration of the study (6 months)
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT01154387
Start Date
July 1 2010
End Date
June 1 2013
Last Update
June 11 2013
Active Locations (12)
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1
University of Colorado Denver
Aurora, Colorado, United States, 80045
2
University of Kentucky
Lexington, Kentucky, United States, 40536
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
4
St Barnabas Medical Center
Livingston, New Jersey, United States, 07039