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Regulatory T Cell Modulation in Kidney Transplantation with Biologic Blockade of Dual Effector Pathways, CD28 and IL-6 (CTOT-24)

Primary Objective

Primary Objective: This study will evaluate the safety of the investigational agent lulizumab pegol (BMS-931699), administered with an immunosuppressive regimen that includes tocilizumab, in adult living-donor kidney transplant recipients in the first 6 months after transplantation. Secondary Objective: This study will also evaluate the safety of the study therapy regimen in adult living donor kidney transplant recipients 6 to 12 months after transplantation.

Study category: Kidney Disease & Hypertension

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Description

CTOT-24 is a multi-center, open-label, single arm clinical trial for kidney transplant recipients. This study will evaluate a new combination of 4 anti-rejection drugs to determine if it is safe and will prevent rejection of the transplanted kidney with fewer side effects than the standard treatment. Study participants will be enrolled prior to transplantation, will receive study drugs for one year after the transplant and will be followed for health status and kidney function for an additional year.

Details
Age

Adult

Eligibility

INCLUSION CRITERIA - Male or female, 18 to 70 years - Recipient of primary, non-HLA identical living donor kidney transplant - EBV positive serology - CMV positive serology, unless donor-recipient pair are both CMV negative - Negative testing for latent TB infection within 3 months prior to transplant. - In the absence of contraindication, vaccinations should be up to date for hepatitis B, influenza, pneumococcal, varicella and herpes zoster, and MMR. EXCLUSION CRITERIA - Candidate for a multiple solid organ or tissue transplants - Prior history of organ or cellular transplantation - Known to have idiopathic FSGS as the underlying cause of ESRD - Requirement for uninterrupted anticoagulation therapy, including Plavix - HIV infected subjects, including those who are well controlled on anti-retrovirals - Positive HBsAg or HBcAb serology - Hepatitis C virus positive (HCV+) subjects who have failed to demonstrate sustained viral remission for more than 12 months (after anti-viral treatment) - Subjects with a previous history of active Tuberculosis (TB) - Known active current viral, fungal, mycobacterial or other infections (including, but not limited to tuberculosis and atypical mycobacterial disease, Hepatitis B and C, and herpes zoster) - Donor or recipient residing in areas which are moderately or highly endemic (annual incidence &#8805;21 cases/100,000) for coccidioidomycosis according to current CDC map (https://www.cdc.gov/fungal/diseases/coccidioidomycosis/causes.html). Donor or recipients residing in low risk zones (annual <21 cases/100,000) will not require additional screening. - History of malignancy except treated basal cell cancer of the skin - History of hemolytic-uremic syndrome/ thrombotic thrombocytopenia purpura - History of gastrointestinal perforations, active inflammatory bowel disease or diverticulitis - Severe hyperlipidemia (total cholesterol >350 mg/dL, LDL >190 mg/dL, or triglycerides >500 mg/dL) - Participation in any other studies with investigational drugs or regimens in the preceding year

Phase

I/II - A combination of phases: (1) Research Studies that focus on the safety of a drug. The goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These studies usually involve a small number of participants; and (2) Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Type of Study

Treatment

Scope

National

Locations

Pathology - SOM
University of Colorado Hospital

Principal Investigator
Alexander Wiseman

Alexander Wiseman

Study ID

Protocol Number: 19-2362

ClinicalTrials.gov: NCT04066114

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