Evaluating Safety and Efficacy of TOL101 Induction Versus Anti-Thymocyte Globulin to Prevent Kidney Transplant Rejection

Status unconfirmed · Phase 1/Phase 2

Conditions studied: End Stage Renal Disease, Renal Transplant

In brief

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 initial rejection response. In general, induction therapy is associated with better outcomes compared to the absence of induction therapy. However, currently used induction agents, some of which are not labeled or indicated for induction therapy in transplantation, have drawbacks related to long-term immune system suppression increasing susceptibility to opportunistic infections or malignancies, and other immune-mediated side effects. 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.

Key facts

Study ID

NCT01154387

Run by

Tolera Therapeutics, Inc

People needed

85

Starts

2010-07-01

Expected to finish

2013-06-01

Last updated by the study team

2013-06-11

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.