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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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 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.

Official Title

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

Keywords

Kidney Transplant Kidney Transplantation infliximab Tissue Donors Remicade Induction Therapy Deceased Donor Kidney Transplant Recipients Prednisolone acetate Methylprednisolone acetate Prednisone Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone Prednisolone hemisuccinate Prednisolone phosphate Mycophenolic Acid Tacrolimus Thymoglobulin Antilymphocyte Serum Acetaminophen Diphenhydramine Promethazine Loratadine

Eligibility

You can join if…

Open to people ages 18 years and up

  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 >35 to <95
  6. Female participants of childbearing potential must have a negative pregnancy test upon study entry

You CAN'T join if...

  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. HIV+ recipients
  5. EBV 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 treatment
  10. . Recipients with a previous history of active TB
  11. . Patients with a positive test for TB exposure (PPD, QuantiFERON, ELISPOT) without history of active infection who have NOT completed a full course of INH therapy.Subjects must have TB test within 1 year prior to transplant. (Refer to Section 8 for additional information)
  12. . Any infection at the time of transplantation
  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-TNF products
  16. . Subjects in whom rATG or infliximab might not be tolerated
  17. . Subjects with less than 3000/mm3 WBC

  18. . Subjects with less than 100,000/mm3 platelets counts

  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 CXR 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 US 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.
  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 IVIG treatment peritransplant.
  25. . Use of an investigational agent within 4-weeks prior to study entry.

Locations

  • University of California, San Francisco accepting new patients
    San Francisco, California, 94143, United States
  • University of California, Los Angeles accepting new patients
    Los Angeles, California, 90024, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Links
National Institute of Allergy and Infectious Diseases (NIAID)
Clinical Trials in Organ Transplantation (CTOT)
ID
NCT02495077
Phase
Phase 2
Lead Scientist
Flavio Vincenti
Study Type
Interventional
Last Updated
September 21, 2017
I’m interested in this study!