NCT01430156

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 7, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

1.4 years

First QC Date

August 30, 2011

Last Update Submit

May 26, 2015

Conditions

Graft FailureIschemia-reperfusion Injury

Keywords

Renal TransplantationIschemia-reperfusion injuryHeme-oxygenase 1Heme arginate

Outcome Measures

Primary Outcomes (1)

  • Macrophage/monocyte HO-1 protein levels

    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

    24 hours

Secondary Outcomes (4)

  • Macrophage/monocyte HO-1 mRNA levels

    24 hours

  • HO-1 protein in kidney transplant

    5 days

  • Effect on transplanted kidney function

    daily for 5 days

  • Urinary biomarkers as markers of injury

    daily for 5 days

Study Arms (2)

Heme arginate (Normosang)

ACTIVE COMPARATOR

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.

Drug: Heme arginate (Normosang)

0.9% saline

PLACEBO COMPARATOR

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

Drug: 0.9% sodium chloride

Interventions

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.

Also known as: Heme Arginate, Hemin
Heme arginate (Normosang)
0.9% sodium chlorideDRUG

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

Also known as: Normal saline
0.9% saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Infirmary of Edinburgh/ University of Edinburgh

Edinburgh, Lothian, EH16 4TJ, United Kingdom

Location

Related Publications (1)

  • Thomas RA, Czopek A, Bellamy CO, McNally SJ, Kluth DC, Marson LP. Hemin Preconditioning Upregulates Heme Oxygenase-1 in Deceased Donor Renal Transplant Recipients: A Randomized, Controlled, Phase IIB Trial. Transplantation. 2016 Jan;100(1):176-83. doi: 10.1097/TP.0000000000000770.

    PMID: 26680374DERIVED

MeSH Terms

Conditions

Reperfusion Injury

Interventions

heme arginateHeminSodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HemeMetalloporphyrinsPorphyrinsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic CompoundsPigments, BiologicalBiological FactorsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Lorna Marson, MD

    Senior Lecturer, Transplant Surgery, University of Edinburgh

    STUDY DIRECTOR

  • Rachel Thomas, MBChB

    Clinical Research Fellow, University of Edinburgh

    PRINCIPAL INVESTIGATOR

  • Stephen McNally, PhD

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

  • David Kluth, PhD

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2011

First Posted

September 7, 2011

Study Start

January 1, 2012

Primary Completion

June 1, 2013

Study Completion

August 1, 2013

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

GB(1)