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.

Conditions

• Kidney Transplant

Interventions

BIOLOGICAL

Infliximab

A single dose, of 3mg/kg infusion

DRUG

Methylprednisolone

500mg will be Initiated just prior to or at the initiation of transplant surgery and prior to Infliximab and thymoglobulin infusion

DRUG

Mycophenolate Mofetil

Administered at a target dose of 2000mg daily, as tolerated, until study closure

DRUG

Tacrolimus

Administered at a target dose of 0.1mg/kg BID, post-op, then adjusted to target trough levels of 8-12ng/ml during 1st 3-months post-op and finally adjusted to target trough levels of 5-8ng/ml until study closure

BIOLOGICAL

Thymoglobulin®

Administered daily for 5 days with the intention of achieving a total dose of 4.5 to 6.0 mg/kg, as tolerated

DRUG

Acetaminophen

30 to 60 minutes prior to the start of the infusion * Tylenol, 600 to 1000mg by mouth or * Suppository form

DRUG

Loratadine

30 to 60 minutes prior to the start of the infusion * Claritin (Loratadine) 10mg by mouth or * Benadryl (Diphenhydramine) 25 or 50 mg by mouth

BIOLOGICAL

Placebo for Infliximab

A single dose is volume matched to Infliximab (250mL) infusion

DRUG

Prednisone

Prednisone will be administered peri-operatively according to center practice. Prednisone should be gradually tapered to no less than 5 mg/day or 10 mg every other day by 3 months post-transplant thereafter until study closure.

DRUG

Diphenhydramine

30 to 60 minutes prior to the start of the infusion * Claritin (Loratadine) 10mg by mouth or * Benadryl (Diphenhydramine) 25 or 50 mg by mouth

Sponsors & Collaborators

• Clinical Trials in Organ Transplantation

  collaborator NETWORK

• Rho Federal Systems Division, Inc.

  collaborator INDUSTRY

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Peter S. Heeger, MD · Icahn School of Medicine at Mount Sinai, Recanati Miller Transplant Institute

• Donald E Hricik, MD · University Hospitals of Cleveland, Division of Nephrology & Hypertension

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-11-02

Primary Completion

2021-07-23

Completion

2021-07-23

Countries

• United States
• Canada

Study Locations