Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-02-20 @ 10:44 PM
Study NCT ID:
NCT01430156
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2011-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Induction of HO-1; a Therapeutic Approach to Reduce Ischaemia Reperfusion Injury (IRI) Following Deceased Donor Renal Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015427', 'term': 'Reperfusion Injury'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C048849', 'term': 'heme arginate'}, {'id': 'D006427', 'term': 'Hemin'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D006418', 'term': 'Heme'}, {'id': 'D008665', 'term': 'Metalloporphyrins'}, {'id': 'D011166', 'term': 'Porphyrins'}, {'id': 'D045725', 'term': 'Tetrapyrroles'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-26', 'studyFirstSubmitDate': '2011-08-30', 'studyFirstSubmitQcDate': '2011-09-06', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Macrophage/monocyte HO-1 protein levels', 'timeFrame': '24 hours', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Macrophage/monocyte HO-1 mRNA levels', 'timeFrame': '24 hours', 'description': 'We will measure HO-1 mRNA levels in macrophages/monocytes from a peripheral blood sample taken at 24 hours.'}, {'measure': 'HO-1 protein in kidney transplant', 'timeFrame': '5 days', 'description': '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'}, {'measure': 'Effect on transplanted kidney function', 'timeFrame': 'daily for 5 days', 'description': 'We will record how the kidney functions by determining presence or absence of delayed graft function.'}, {'measure': 'Urinary biomarkers as markers of injury', 'timeFrame': 'daily for 5 days', 'description': 'We will collect urine to measure the presence of specific urinary biomarkers and correlate with renal function.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Renal Transplantation', 'Ischemia-reperfusion injury', 'Heme-oxygenase 1', 'Heme arginate'], 'conditions': ['Graft Failure', 'Ischemia-reperfusion Injury']}, 'referencesModule': {'references': [{'pmid': '26680374', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe investigators will be giving HA/placebo to participants prior to transplant and repeat again on day 2 post-transplant and compare outcomes.', 'detailedDescription': '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.\n\nA 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.\n\nPatients 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients receiving a cadaveric single kidney transplant\n* patients on a standard immunosuppressive regime\n\nExclusion Criteria:\n\n* patients on different immunosuppressives\n* patients receiving 3rd or subsequent kidney transplant\n* patients are fully anti-coagulated\n* patients unable to take Heme Arginate\n* patients unable to give informed consent\n* patients on combined anti-platelet agents'}, 'identificationModule': {'nctId': 'NCT01430156', 'acronym': 'HOT', 'briefTitle': 'Induction of HO-1; a Therapeutic Approach to Reduce Ischaemia Reperfusion Injury (IRI) Following Deceased Donor Renal Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'University of Edinburgh'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'HOT-2011'}, 'secondaryIdInfos': [{'id': '2011-004311-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Heme arginate (Normosang)', 'description': '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.', 'interventionNames': ['Drug: Heme arginate (Normosang)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '0.9% saline', 'description': 'The saline will be given as an IV infusion in the same manner as the Heme Arginate (active comparator) infusion.', 'interventionNames': ['Drug: 0.9% sodium chloride']}], 'interventions': [{'name': 'Heme arginate (Normosang)', 'type': 'DRUG', 'otherNames': ['Heme Arginate', 'Hemin'], 'description': '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.', 'armGroupLabels': ['Heme arginate (Normosang)']}, {'name': '0.9% sodium chloride', 'type': 'DRUG', 'otherNames': ['Normal saline'], 'description': 'Solution for infusion, this will be given prior to transplantation and again on day 2; the same as active drug.', 'armGroupLabels': ['0.9% saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EH16 4TJ', 'city': 'Edinburgh', 'state': 'Lothian', 'country': 'United Kingdom', 'facility': 'Royal Infirmary of Edinburgh/ University of Edinburgh', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}], 'overallOfficials': [{'name': 'Lorna Marson, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Senior Lecturer, Transplant Surgery, University of Edinburgh'}, {'name': 'Rachel Thomas, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research Fellow, University of Edinburgh'}, {'name': 'Stephen McNally, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Edinburgh'}, {'name': 'David Kluth, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Edinburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Edinburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'NHS Lothian', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}