Kidney Cancer Clinical Trial
Effects of Inhibiting Early Inflammation in Kidney Transplant Patients
Summary
During transplant surgery, there is a period of time when a donated kidney is removed from a donor's body and stored until the time of the transplant surgery. The storage procedure results in buildup of various proteins within the kidney that can injure the donated kidney after it is transplanted. One of these proteins is tumor necrosis factor-alpha (TNF-alpha).
The purpose of this study is to evaluate whether taking infliximab, which blocks tumor necrosis factor alpha (TNF-alpha), just prior to transplant surgery, along with usual transplant medicines will protect the donated kidney from damage caused by TNF-alpha and help keep the transplanted kidney healthy for a longer period of time.
Full Description
This is a Phase 2, multicenter, randomized, double blind (masked), placebo-controlled, 2-arm clinical trial of 300 deceased donor kidney transplant recipients. Participants will be randomized (1:1) to the experimental or control arm (150 subjects per arm).
Eligibility Criteria
Inclusion Criteria:
Adult (>18 years of age) male and female recipients (all races and ethnicities)
Subject must be able to understand and provide consent
Recipients of deceased donor kidney transplants (including re-transplants)
Negative crossmatch, actual or virtual, or a PRA of 0% on historic and current sera as determined by each participating study center
Donor kidneys from deceased donors and donors after cardiac death (DCD) with Kidney Donor Profile Indices (KDPI) ranging from ≥20 to <95
Female participants of childbearing potential must have a negative pregnancy test upon study entry
Subjects must have a negative test result for latent tuberculosis (TB) infection (PPD, QuantiFERON, ELISPOT):
Subjects who have a negative test result for latent TB infection within 1 year of transplant date are eligible for enrollment and no further action is required
Subjects who have a negative test for latent TB infection that is greater than 1 year old are eligible for enrollment but are required to have a repeat test prior to transplantation.
Exclusion Criteria:
Inability or unwillingness of a participant to give written informed consent or comply with study protocol
Recipients of living donor transplants
Presence of other transplanted solid organ (heart, lung, liver, pancreas, small intestines) or co-transplanted organ
Human immunodeficiency virus positive (HIV+) recipients
Epstein-Barr virus Immunoglobulin G (EBV IgG) negative recipients
Hepatitis B surface antigen positive kidney transplant recipients
Hepatitis B core antibody positive kidney transplant recipients
Hepatitis B negative kidney transplant recipients that receive transplants from Hepatitis B core antibody positive donor
Hepatitis C Virus positive (HCV+) patients who are either untreated or have failed to demonstrate sustained viral remission for more than 12 months after anti-viral treatment
Recipients with a previous history of active TB
Recipients with a positive test for latent TB infection (PPD, QuantiFERON, ELISPOT), regardless of previous therapy
Any severe infection at the time of transplantation.
--Note: Severe infection determination will be made by the local site investigator.
Severe congestive heart failure (NYHA functional class III or higher)
Subjects with a known hypersensitivity to any murine/ mouse proteins
Subjects with any history of receiving any anti-tumor necrosis factor (anti- TNF) products
Subjects in whom rabbit anti-thymocyte globulin (Thymoglobulin®) or infliximab might not be tolerated
Subjects with a white blood cell count less than 3000/mm^3
Subjects with a platelet count less than 100,000/mm^3
Subjects with systolic blood pressure <100 mm/Hg
Subjects with symptomatic orthostatic hypotension or currently requiring Midodrine for blood pressure support
Subjects from, or who have traveled, to endemic areas with a history of active histoplasmosis or, with a chest x-ray consistent with previous active histoplasmosis (no serological testing required) :
--Endemic regions determined by site based on local standard of care.
Subjects currently or formerly residing in regions of the United States that are highly endemic for coccidioidomycosis, and who have a positive serologic test for coccidioidomycosis:
--Endemic regions determined by site based on local standard of care.
Recipients are excluded if the local site decides to treat the recipient with fluconazole because of diagnosis or suspicion of fungal infection the donor
Subjects that receive IVIG treatment within 3 months of transplant or planned intravenous immunoglobulin (IVIG) treatment peri-transplant
Use of an investigational agent within 4-weeks prior to study entry.
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There are 14 Locations for this study
Birmingham Alabama, 35294, United States
Los Angeles California, 90024, United States
San Francisco California, 94143, United States
New Haven Connecticut, 06511, United States
Atlanta Georgia, 30322, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21287, United States
Ann Arbor Michigan, 48109, United States
Saint Louis Missouri, 63110, United States
New York New York, 10029, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44106, United States
Madison Wisconsin, 53792, United States
Winnipeg Manitoba, R3A 1, Canada
Toronto Ontario, M5G 2, Canada
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