NCT02495077

Effects of Inhibiting Early Inflammation in Kidney Transplant Patients

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 290 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• Kidney Transplant

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-11-02
• Primary completion: 2021-07-23
• Completion: 2021-07-23
• First posted: 2015-07-13
• Last updated: 2022-08-16
• Results posted: 2022-08-16

Locations

15 sites across 2 countries: United States, Canada