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Completed

NCT Number: NCT01430156

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

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.

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Key information

Conditions

Graft Failure Cardiovascular Diseases Ischemia-Reperfusion Injury Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal Infirmary of Edinburgh/ University of Edinburgh

Edinburgh, Lothian, EH16 4TJ, United Kingdom

About this study

Patients will be recruited from the East of Scotland transplant waiting list and consent when they arrive in the hospital. The investigators will randomise them to drug or placebo and give the infusion prior to induction for their transplant.

A blood sample will be taken prior to infusion and a renal biopsy will be taken before the graft is implanted. These will be used as baseline values.

Patients will receive standard care from our unit. The investigators will use the routine blood test results (urea and creatinine) to determine the function of the graft.

The investigators will take blood samples 24 hours after infusion of drug/placebo and use this to determine the primary outcome. Blood tests will be taken daily and a renal biopsy taken on day 5 to fulfil secondary objectives.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all patients receiving a cadaveric single kidney transplant
  • patients on a standard immunosuppressive regime

Exclusion criteria

  • patients on different immunosuppressives
  • patients receiving 3rd or subsequent kidney transplant
  • patients are fully anti-coagulated
  • patients unable to take Heme Arginate
  • patients unable to give informed consent
  • patients on combined anti-platelet agents

Treatment and study plan

Heme arginate (Normosang)

Drug

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.

Other names: Heme Arginate, Hemin

0.9% Sodium Chloride

Drug

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

Other names: Normal saline

Primary outcomes

  1. Macrophage/monocyte HO-1 protein levels

    Time frame: 24 hours

    We will measure the level of HO-1 protein in isolated macrophages/ monocytes in a peripheral blood sample taken at 24 hours after drug infusion

Secondary outcomes

  1. Macrophage/monocyte HO-1 mRNA levels

    Time frame: 24 hours

    We will measure HO-1 mRNA levels in macrophages/monocytes from a peripheral blood sample taken at 24 hours.

  2. HO-1 protein in kidney transplant

    Time frame: 5 days

    We will measure the level of HO-1 protein in kidney tissue from a biopsy sample taken 5 days after drug infusion. This will be compared to baseline

  3. Effect on transplanted kidney function

    Time frame: daily for 5 days

    We will record how the kidney functions by determining presence or absence of delayed graft function.

  4. Urinary biomarkers as markers of injury

    Time frame: daily for 5 days

    We will collect urine to measure the presence of specific urinary biomarkers and correlate with renal function.

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • NHS Lothian

Registry information

Official study title

A Randomised Placebo-Controlled Trial to Investigate the Effect of Pre-treatment With Haem Arginate (Normosang) on Heme-Oxygenase 1 (HO-1) Upregulation in Recipients of Deceased Donor Kidneys

Acronym: HOT

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 7, 2011
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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