Renaparin® in Kidney Transplantation

Status Completed

Clinical Trial Summary

This study evaluates the safety and tolerability of Renaparin in adult patients receiving a deceased donor kidney treated ex-vivo with Renaparin prior to transplantation. Half the patient group will receive a kidney treated with Renaparin, while the other half of the patient group will receive a kidney treated with placebo.

Clinical Trial Description

Kidney transplantation is the last resort for end-stage renal disease (ESRD). A key problem after transplantation is Delayed Graft Function (DGF). Short term, DGF will result in patients being put on dialysis in the immediate time-period after transplantation. In the longer perspective DGF is associated with increased risk of graft failure, thus decreasing the efficacy of the kidney transplantation.

Renaparin is a new product under development for the prevention of DGF in association with kidney transplantation. The product binds to the kidney vascular endothelium and its pharmacological effect is based on a local and effective presentation of heparin. Renaparin is administered ex vivo to the kidney by adding it to the preservation solution during Hypothermic Machine Perfusion (HMP) prior to transplantation. ;

Study Design

Related Conditions & MeSH terms

Delayed Graft Function

Clinical Trial Details

NCT number	NCT03773211
Study type	Interventional
Source	Corline Biomedical AB
Contact
Status	Completed
Phase	Phase 1
Start date	February 14, 2019
Completion date	April 21, 2020

View Details

See also
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