Evaluating Safety and Efficacy of TOL101 Induction Versus Anti-Thymocyte Globulin to Prevent Kidney Transplant Rejection
NCT ID: NCT01154387
Last Updated: 2013-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
85 participants
INTERVENTIONAL
2010-07-31
2013-06-30
Brief Summary
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An unmet medical need exists for a more specific approach to prevent acute organ rejection, without unnecessarily exposing the patient to non-specific or open-ended immune suppression, which may exacerbate the risks of infections and malignancies. TOL101 is a novel antibody that targets a very specific immune cell type that is critical in the acute organ rejection response. In this two-part study, TOL101 will be evaluated for the prophylaxis of acute organ rejection when used as part of an immunosuppressive regimen that includes steroids, MMF, and tacrolimus in first time kidney transplant recipients.
This study will test the hypothesis that a more specific approach (with TOL101) to prevention of acute organ rejection may provide similar or better efficacy than the currently used induction antibodies (such as Anti-Thymocyte Globulin or Thymoglobulin) while carrying fewer risks in terms of opportunistic infections, malignancies and adverse effects.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Anti-Thymocyte Globulin
Anti-Thymocyte Globulin induction as part of an immunosuppressive regimen that includes steroids, MMF, and tacrolimus.
Anti-Thymocyte Globulin
1.5mg/kg IV on Day of Transplant and 1.0-1.5 mg/kg IV once daily for a minimum of 4.5mg/kg and a maximum of 7.5mg/kg total cumulative dose
Steroids
IV methylprednisolone prior to first 3 doses of study drug; oral prednisone tapered to 5-10 mg over 6 months
Tacrolimus
Oral administration started by 6 days post-transplantation and continued for 6 months
Mycophenolate mofetil (MMF)
Oral administration started by Day 1 post-transplantation and continued for 6 months
TOL101 (Dose A)
TOL101 induction as part of an immunosuppressive regimen that includes steroids, MMF, and tacrolimus.
TOL101
Potential Therapeutic Dose (PTD)-A (0.28-56 mg to be determined in Phase 1/Part A ) IV once daily x 6-10 doses starting on Day of Transplant
Steroids
IV methylprednisolone prior to first 3 doses of study drug; oral prednisone tapered to 5-10 mg over 6 months
Tacrolimus
Oral administration started by 6 days post-transplantation and continued for 6 months
Mycophenolate mofetil (MMF)
Oral administration started by Day 1 post-transplantation and continued for 6 months
TOL101 (Dose B)
TOL101 induction as part of an immunosuppressive regimen that includes steroids, MMF, and tacrolimus.
TOL101
Potential Therapeutic Dose (PTD)-B (0.28-56 mg to be determined in Phase 1/Part A ) IV once daily x 6-10 doses starting on Day of Transplant
Steroids
IV methylprednisolone prior to first 3 doses of study drug; oral prednisone tapered to 5-10 mg over 6 months
Tacrolimus
Oral administration started by 6 days post-transplantation and continued for 6 months
Mycophenolate mofetil (MMF)
Oral administration started by Day 1 post-transplantation and continued for 6 months
Interventions
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Anti-Thymocyte Globulin
1.5mg/kg IV on Day of Transplant and 1.0-1.5 mg/kg IV once daily for a minimum of 4.5mg/kg and a maximum of 7.5mg/kg total cumulative dose
TOL101
Potential Therapeutic Dose (PTD)-A (0.28-56 mg to be determined in Phase 1/Part A ) IV once daily x 6-10 doses starting on Day of Transplant
TOL101
Potential Therapeutic Dose (PTD)-B (0.28-56 mg to be determined in Phase 1/Part A ) IV once daily x 6-10 doses starting on Day of Transplant
Steroids
IV methylprednisolone prior to first 3 doses of study drug; oral prednisone tapered to 5-10 mg over 6 months
Tacrolimus
Oral administration started by 6 days post-transplantation and continued for 6 months
Mycophenolate mofetil (MMF)
Oral administration started by Day 1 post-transplantation and continued for 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female 18-60 years of age
* Recipient with a PRA \< 20%
Exclusion Criteria
* 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)
18 Years
60 Years
ALL
No
Sponsors
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Tolera Therapeutics, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Stuart Flechner, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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University of Colorado Denver
Aurora, Colorado, United States
University of Kentucky
Lexington, Kentucky, United States
University of Michigan
Ann Arbor, Michigan, United States
St Barnabas Medical Center
Livingston, New Jersey, United States
Buffalo General Hospital
Buffalo, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baylor University Medical Center
Dallas, Texas, United States
Baylor All Saints
Fort Worth, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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TTI-121
Identifier Type: -
Identifier Source: org_study_id
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