Clinical trial

Randomized, Double-blind, Placebo-controlled, Parallel-group Pilot Study to Assess Efficacy, Safety and Pharmacokinetics of 2 Schedules of Reparixin in the Prevention of Delayed Graft Function After Kidney Transplant in High Risk Patients

Name

REP0204

Description

The chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear neutrophils in post-ischemia reperfusion injury after solid organ transplantation. Reparixin is a novel, specific inhibitor of CXCL8. This study is configured to explore the safety and efficacy of reparixin in preventing the delayed graft function (DGF) after kidney transplantation.

Trial arms

Trial start

2005-10-01

Estimated PCD

2008-05-01

Trial end

2008-06-01

Status

Completed

Phase

Early phase I

Treatment

Reparixin continuous infusion

The Investigational Product was administered as an intravenous infusion into a (high flow) central vein or through an arterio-venous fistula, by an infusion pump adequate to provide reliable infusion rates, as per treatment schedule. Total infusion volume did not exceed 500 mL/24 hours. A dose of 2.772 mg/kg body weight/hour was to be administered for 12 hours. Placebo was volume/schedule matched saline.

Arms:

reparixin group - continuous infusion

Other names:

REP

reparixin intermittent infusion

A dose of 2.244 mg/kg body weight was to be administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were to be administered over a total period of 22.5 hours. Placebo was volume/schedule matched saline.

Arms:

reparixin group - intermittent infusion

Other names:

REP

placebo infusion

placebo was volume/schedule matched saline

Arms:

placebo infusion

Size

Primary endpoint

Creatinine Clearance (CrCl) in the Immediate Post-transplant Period

1-3 and 10-12 hours post allograft reperfusion

Eligibility criteria

Inclusion Criteria: * Male and female patients accepted and listed for renal transplantation due to end stage renal disease (ESRD) * Planned isolated single kidney transplant from a non-living donor with brain death * Recipients of a kidney maintained in cold storage * Recipients at risk of developing DGF * Planned induction with steroids + mycophenolate mofetil (MMF) or mycophenolic acid + biological induction * Patient willing and able to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations * Patient given written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care Exclusion Criteria: * Recipients of an intended multiple organ transplant * Recipients of a kidney from a living donor * Recipients of a kidney from a non-heart beating donor * Recipients of double kidney transplant * Re-transplant \>2 * Recipients of a kidney maintained by pulsatile machine perfusion * Concurrent sepsis * Recipients with hepatic dysfunction at the time of transplant * Clinical contraindications to central line access, or arteriovenous fistula, if any, not suitable for infusion of investigational product * Hypersensitivity to non steroidal anti-inflammatory drugs (NSAIDs) * Patients simultaneously participating in any other clinical trials involving an investigational drug not yet authorized for use in kidney transplant * Pregnant or breast-feeding women

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ACTUAL'}}

Updated at

2024-01-10

1 organization

1 product

2 indications

Organization

Dompé Farmaceutici

Product

Reparixin

Indication

Ischemia/Reperfusion Injury

Indication

Kidney Diseases