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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-08-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Graft Failure Ischemia-reperfusion Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Heme arginate (Normosang)

This arm will receive 2 doses of Heme Arginate (trade name Normosang); 1 dose prior to transplant and another on day 2. This is a product derived from human hemin and has been used for over 20 years in clinical practice with few side-effects.

Group Type ACTIVE_COMPARATOR

Heme arginate (Normosang)

Intervention Type 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.

0.9% saline

The saline will be given as an IV infusion in the same manner as the Heme Arginate (active comparator) infusion.

Group Type PLACEBO_COMPARATOR

0.9% sodium chloride

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Heme Arginate Hemin Normal saline

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No