Effects of Inhibiting Early Inflammation in Kidney Transplant Patients

Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Age Range:18 - Any
Start Date:November 2, 2015
End Date:June 2021

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Randomized Controlled Trial of Infliximab (Remicade®) Induction Therapy for Deceased Donor Kidney Transplant Recipients (CTOT-19)

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.

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).

Inclusion Criteria:

1. Adult (>18 years of age) male and female recipients (all races and ethnicities)

2. Subject must be able to understand and provide consent

3. Recipients of deceased donor kidney transplants (including re-transplants)

4. Negative crossmatch, actual or virtual, or a PRA of 0% on historic and current sera as
determined by each participating study center

5. Donor kidneys from deceased donors and donors after cardiac death (DCD) with Kidney
Donor Profile Indices (KDPI) ranging from ≥20 to <95

6. Female participants of childbearing potential must have a negative pregnancy test upon
study entry

7. Subjects must have a negative test result for latent tuberculosis (TB) infection (PPD,

- 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:

1. Inability or unwillingness of a participant to give written informed consent or comply
with study protocol

2. Recipients of living donor transplants

3. Presence of other transplanted solid organ (heart, lung, liver, pancreas, small
intestines) or co-transplanted organ

4. Human immunodeficiency virus positive (HIV+) recipients

5. Epstein-Barr virus Immunoglobulin G (EBV IgG) negative recipients

6. Hepatitis B surface antigen positive kidney transplant recipients

7. Hepatitis B core antibody positive kidney transplant recipients

8. Hepatitis B negative kidney transplant recipients that receive transplants from
Hepatitis B core antibody positive donor

9. 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

10. Recipients with a previous history of active TB

11. Recipients with a positive test for latent TB infection (PPD, QuantiFERON, ELISPOT),
regardless of previous therapy

12. Any severe infection at the time of transplantation.

--Note: Severe infection determination will be made by the local site investigator.

13. Severe congestive heart failure (NYHA functional class III or higher)

14. Subjects with a known hypersensitivity to any murine/ mouse proteins

15. Subjects with any history of receiving any anti-tumor necrosis factor (anti- TNF)

16. Subjects in whom rabbit anti-thymocyte globulin (Thymoglobulin®) or infliximab might
not be tolerated

17. Subjects with a white blood cell count less than 3000/mm^3

18. Subjects with a platelet count less than 100,000/mm^3

19. Subjects with systolic blood pressure <100 mm/Hg

20. Subjects with symptomatic orthostatic hypotension or currently requiring Midodrine for
blood pressure support

21. 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.

22. 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

--Endemic regions determined by site based on local standard of care.

23. Recipients are excluded if the local site decides to treat the recipient with
fluconazole because of diagnosis or suspicion of fungal infection the donor

24. Subjects that receive IVIG treatment within 3 months of transplant or planned
intravenous immunoglobulin (IVIG) treatment peri-transplant

25. Use of an investigational agent within 4-weeks prior to study entry.
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