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Summary

for people ages 18 years and up
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 Mycophenolate mofetil Antilymphocyte Serum Acetaminophen Diphenhydramine Promethazine Loratadine

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Subject must be able to understand and provide consent
  2. Recipients of deceased donor kidney transplants
  3. Recipients of HLA mismatched kidneys
  4. Recipients who are virtual cross match negative as determined by local HLA lab
  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 organ or co-transplanted organ
  4. Recipients of kidneys with zero HLA mismatches
  5. HIV+ recipients
  6. EBV negative recipients
  7. Hepatitis B surface antigen positive kidney transplant recipients
  8. Hepatitis B core antibody positive kidney transplant recipients
  9. Hepatitis B negative kidney transplant recipients that receive transplants from Hepatitis B core antibody positive donor
  10. 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
  11. Recipients with a previous history of active TB
  12. 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
  13. Recipients with a positive virtual cross match as determined by the local HLA lab
  14. Any infection at the time of transplantation
  15. Severe congestive heart failure (NYHA functional class III or higher)
  16. Subjects with a known hypersensitivity to any murine/ mouse proteins.
  17. Subjects with any history of receiving any anti-TNF products
  18. Subjects in whom rATG or infliximab might not be tolerated
  19. Subjects with less than 3000/mm^3 WBC
  20. Subjects with less than 100,000/mm^3 platelets counts
  21. Subjects with systolic blood pressure < 100 mm/Hg
  22. Subjects with symptomatic orthostatic hypotension or currently requiring Midodrine for blood pressure support
  23. 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).
  24. 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.

Locations

  • University of California, Los Angeles not yet accepting 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 1, 2016
I’m interested in this study!