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Effects of Inhibiting Early Inflammation in Kidney Transplant Patients

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Transplant

Intervention: Infliximab (Biological); Methylprednisolone (Drug); Mycophenolate Mofetil (Drug); Tacrolimus (Drug); Thymoglobulin (Biological); Acetaminophen (Drug); Loratadine (Drug); Placebo for Infliximab (Biological); Prednisone (Drug); Diphenhydramine (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: The difference between the mean eGFR (modified MDRD) in the experimental vs. control groups.

Secondary outcome:

Proportion of subjects with biopsy proven acute cellular rejection (BPAR)

Proportion of subjects with biopsy proven acute cellular rejection (BPAR).

BANFF grades of first Acute Cellular Rejections (ACR).

Proportion of subjects with biopsy proven acute cellular rejection (BPAR) or borderline rejection.

Proportion of subjects with biopsy proven acute cellular rejection (BPAR) or borderline rejection

Proportion of subjects with biopsy proven acute antibody mediated rejection (AMR)

Proportion of subjects with biopsy proven acute antibody mediated rejection (AMR).

Proportion of subjects with biopsy proven acute antibody mediated rejection AMR or suspicious for AMR

Proportion of subjects with biopsy proven acute antibody mediated rejection AMR or suspicious for AMR.

BANFF grades of first AMR.

Proportion of subjects with BANFF chronicity scores > or equal 2.

Change in BANFF chronicity scores Change Between implantation and 24 month biopsies.

Change in eGFR between 3 months and 24 months

Change in eGFR between post-transplant nadir and 24 months

eGFR Values

Proportion of subjects with death or graft failure.

Proportion of subjects with only graft failure.

Proportion of subjects that required at least one dialysis treatment.

Number of dialysis sessions.

Duration of delayed graft function (DGF) defined from transplantation to the last required dialysis treatment.

The incidence of primary non-function (PNF), defined as for dialysis-dependency for more than 3 months.

Change from baseline (immediately after surgery) in serum creatinine and serum creatinine concentration.

Event (ACR, AMR, or hospitalization for infection and or malignancy)

Proportion of Slow Graft Function (SGF)

Ratio of Slow Graft Function (SGF)

Proportion of Slow Graft Function (SGF)

Proportion of Slow Graft Function (SGF)

Proportion of Slow Graft Function

Proportion of subjects with any infection requiring hospitalization or resulting in death.

Proportion of subjects with Mycobacterial or fungal infections

Proportion of subjects with CMV viremia require a change in immunosuppression or anti-viral treatment as per standard of care at the site

Proportion of subjects with BK viremia that require a change in immunosuppression or anti-viral treatment as per standard of care at the site.

Proportion of subjects with malignancy.

Proportion of subjects with impaired wound healing manifested by wound dehiscence, wound infection, or hernia at the site of the transplant incision

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 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 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 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 and Contacts

Additional Information

Starting date: August 2015
Last updated: July 8, 2015

Page last updated: August 23, 2015

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