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Induction of HO-1; a Therapeutic Approach to Reduce Ischaemia Reperfusion Injury (IRI) Following Deceased Donor Renal Transplantation

NCT01430156 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-05-27

No results posted yet for this study

Summary

This is a blinded, placebo-controlled, randomised controlled trial looking at the effects of Heme arginate (HA) on cadaveric renal transplantation. The investigators know that HA can upregulate HO-1, which has been shown to have a protective effect on animal transplants.

The investigators will be giving HA/placebo to participants prior to transplant and repeat again on day 2 post-transplant and compare outcomes.

Conditions

  • Graft Failure
  • Ischemia-reperfusion Injury

Interventions

DRUG

Heme arginate (Normosang)

3mg/kg as a single IV infusion prior to transplant over 30 mins and same dose repeated on day 2 post-transplantation. Each drug infusion will be followed by 100ml saline IV to flush the line.

DRUG

0.9% sodium chloride

Solution for infusion, this will be given prior to transplantation and again on day 2; the same as active drug.

Sponsors & Collaborators

  • NHS Lothian

    collaborator OTHER_GOV

  • University of Edinburgh

    lead OTHER

Principal Investigators

  • Lorna Marson, MD · Senior Lecturer, Transplant Surgery, University of Edinburgh

  • Rachel Thomas, MBChB · Clinical Research Fellow, University of Edinburgh

  • Stephen McNally, PhD · University of Edinburgh

  • David Kluth, PhD · University of Edinburgh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-06-30
Completion
2013-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01430156 on ClinicalTrials.gov