Effects of Inhibiting Early Inflammation in Kidney Transplant Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

290

Participants

Timeline

Start Date

November 2, 2015

Primary Completion Date

July 23, 2021

Study Completion Date

July 23, 2021

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"

Trial Locations (15)

10029

Mount Sinai Medical Center, New York

21201

University of Maryland, Baltimore

21287

Johns Hopkins University, Baltimore

30322

Emory University, Atlanta

35294

University of Alabama at Birmingham, Birmingham

44106

Cleveland Clinic, Cleveland

University Hospitals of Cleveland, Cleveland

48109

University of Michigan, Ann Arbor

53792

University of Wisconsin, Madison

63110

Washington University School of Medicine in St. Louis, St Louis

90024

University of California, Los Angeles, Los Angeles

94143

University of California, San Francisco, San Francisco

06511

Yale University, New Haven

R3A 1R9

University of Manitoba, Winnipeg

M5G 2C4

Toronto General Hospital, Toronto

All Listed Sponsors
collaborator

Clinical Trials in Organ Transplantation

NETWORK

collaborator

Rho Federal Systems Division, Inc.

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT02495077 - Effects of Inhibiting Early Inflammation in Kidney Transplant Patients | Biotech Hunter | Biotech Hunter