Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-03-01 @ 1:26 PM
Study NCT ID:
NCT01744067
Status:
COMPLETED
Last Update Posted:
2015-12-08
First Post:
2012-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Omega-3 Fatty Acids in Renal Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011507', 'term': 'Proteinuria'}, {'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'C405603', 'term': 'Omacor'}, {'id': 'D000069463', 'term': 'Olive Oil'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-06', 'studyFirstSubmitDate': '2012-12-04', 'studyFirstSubmitQcDate': '2012-12-04', 'lastUpdatePostDateStruct': {'date': '2015-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of post-transplant complications', 'timeFrame': '44 weeks + 8 weeks'}, {'measure': 'Adverse events', 'timeFrame': '44 weeks + 8 weeks'}, {'measure': 'Adverse reactions', 'timeFrame': '44 weeks'}, {'measure': 'Frequency of clinically significant safety laboratory variables', 'timeFrame': '44 weeks', 'description': 'Especially INR and tacrolimus trough concentrations. Follow-up by local nephrologist plus five Telephone Controls during follow-up.'}, {'measure': 'Quality of life', 'timeFrame': '44 weeks', 'description': 'The participants fill out SF-36 at baseline and the 1 year post transplant control for both safety reasons and measurement of differences between the groups with regards to quality of life.'}, {'measure': 'Food questionnaire', 'timeFrame': '44 weeks', 'description': 'Two specially designed food questionnaires to obtain data on dietary habits in general and type and amount of fish consumed'}, {'measure': 'Comorbidity, concomitant medication and life-style factor interview', 'timeFrame': '44 weeks'}], 'primaryOutcomes': [{'measure': 'Glomerular filtration rate', 'timeFrame': '44 weeks', 'description': 'Iohexol clearance'}], 'secondaryOutcomes': [{'measure': 'Proteinuria', 'timeFrame': '44 weeks', 'description': 'Both ACR and FEPR'}, {'measure': 'Inflammation in the renal transplant', 'timeFrame': '44 weeks', 'description': 'Degree of total inflammation in renal transplant biopsies, scores by PI and rescored by two pathologists.'}, {'measure': 'Fibrosis in the renal transplant', 'timeFrame': '44 weeks', 'description': 'As for inflammation'}, {'measure': 'Blood pressure', 'timeFrame': '44 weeks'}, {'measure': 'Heart rate variability', 'timeFrame': '44 weeks'}, {'measure': 'Flow mediated dilation', 'timeFrame': '44 weeks'}, {'measure': 'Pulse wave velocity and augmentation index', 'timeFrame': '44 weeks'}, {'measure': 'Blood glucose', 'timeFrame': '44 weeks', 'description': 'HbA1c and oral glucose tolerance test'}, {'measure': 'Lipids', 'timeFrame': '44 weeks', 'description': 'Total, LDL and HDL cholesterol, triglycerid and ratios'}, {'measure': 'Body composition', 'timeFrame': '44 weeks', 'description': 'Visceral fat volume and weight, visceral to subcutaneous fat ratio.'}, {'measure': 'Bone mineral density', 'timeFrame': '44 weeks', 'description': 'Regular BMD in the lumbar spine, hips, femur and arms and also selected to trabecular bone.'}, {'measure': 'Body mass index', 'timeFrame': '44 weeks'}, {'measure': 'Vitamin D levels', 'timeFrame': '44 weeks'}, {'measure': 'Fatty acid composition in plasma and renal tissue', 'timeFrame': '44 weeks'}, {'measure': 'Tacrolimus pharmacokinetics', 'timeFrame': '12 weeks', 'description': 'Substudy of 15 patients, where we study tacrolimus trough levels, Tmax and AUC at the end of the ORENTRA trial, after a minimum of 4 weeks wash-out and again after 4 weeks of 2.7 g omega-3 fatty acid supplementation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Renal transplantation', 'Interventional study', 'Glomerular filtration rate', 'Renal function', 'Proteinuria', 'Cardiovascular risk markers', 'Blood pressure', 'Flow mediated vasodilation', 'Heart rate variability', 'Pulse wave velocity', 'Lipids', 'Blood glucose', 'Bone mineral density', 'Body composition', 'Fat distribution', 'Body mass index', 'Fatty acid composition', 'Tacrolimus pharmacokinetics', 'Omega-3 fatty acids', 'Marine n-3 fatty acids', 'Fatty acids', 'Gas chromatography', 'Interstitial fibrosis', 'Inflammation'], 'conditions': ['Disorder Related to Renal Transplantation']}, 'referencesModule': {'references': [{'pmid': '34939013', 'type': 'DERIVED', 'citation': 'Chan J, Eide IA, Tannaes TM, Waldum-Grevbo B, Jenssen T, Svensson M. Marine n-3 Polyunsaturated Fatty Acids and Cellular Senescence Markers in Incident Kidney Transplant Recipients: The Omega-3 Fatty Acids in Renal Transplantation (ORENTRA) Randomized Clinical Trial. Kidney Med. 2021 Oct 4;3(6):1041-1049. doi: 10.1016/j.xkme.2021.07.010. eCollection 2021 Nov-Dec.'}, {'pmid': '30125457', 'type': 'DERIVED', 'citation': 'Eide IA, Reinholt FP, Jenssen T, Hartmann A, Schmidt EB, Asberg A, Bergan S, Brabrand K, Svensson M. Effects of marine n-3 fatty acid supplementation in renal transplantation: A randomized controlled trial. Am J Transplant. 2019 Mar;19(3):790-800. doi: 10.1111/ajt.15080. Epub 2018 Sep 22.'}]}, 'descriptionModule': {'briefSummary': 'Omega-3 fatty acids are provided through dietary intake of fish and seafood. Several dietary supplements containing omega-3 fatty acids are also commercially available. Some studies have described beneficial effects from omega-3 fatty acids, among them are anti-inflammatory, anti-thrombotic, anti-atherosclerotic, anti-arrhythmic, anti-hypertensive and lipid-modulating effects. Other studies have not confirmed these findings. This study will investigate the effects of omega-3 fatty acids on renal function and cardiovascular risk markers in renal transplant recipients.', 'detailedDescription': 'There have been few interventional studies regarding the clinical effect of omega-3 fatty acids in renal transplantation. The aim of this study is to investigate the effects of omega-3 fatty acids on renal function and cardiovascular risk markers in renal transplant recipients.\n\nThis study is a randomized double blinded placebo controlled interventional study of 132 Norwegian renal transplant recipients. It will investigate, on the one hand, the effect of omega-3 fatty acids on renal function and, on the other, the effect of omega-3 fatty acids on cardiovascular risk markers in renal transplant recipients.\n\n8 weeks after transplantation, if renal function has stabilized, patients with a eGFR\\>30 will be randomized to receive either 2,7 g eicosapentaenoic plus docosahexaenoic acid (3 capsules of Omacor a 1 g) daily or placebo. Baseline measurements will be performed before they start taking the study medication. The same measurements will performed again1 year after transplantation and the patients stops taking the study medication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over the age of 18 who have received a kidney transplant. Patients with a functioning kidney transplant, defined as eGFR\\>30 ml/min. Signed informed consent.\n\nExclusion Criteria:\n\n* Patients participating in clinical trials with other investigational drugs. Patients who received a deceased donor kidney from a donor \\>75 years. Patients with a history of an allergic reaction or significant sensitivity to the study drug or drugs similar to the study drug.'}, 'identificationModule': {'nctId': 'NCT01744067', 'acronym': 'ORENTRA', 'briefTitle': 'The Effects of Omega-3 Fatty Acids in Renal Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'The Effects of n-3 Polyunsaturated Fatty Acids on Renal and Cardiovascular Risk Markers in Renal Transplant Recipients: a Randomized Double Blinded Placebo Controlled Intervention Study.', 'orgStudyIdInfo': {'id': '2012/1419'}, 'secondaryIdInfos': [{'id': '2012-004992-37', 'type': 'EUDRACT_NUMBER'}, {'id': '2012033', 'type': 'OTHER_GRANT', 'domain': 'Norway: Regional Health Authority'}, {'id': '2012/1419', 'type': 'OTHER', 'domain': 'Norway: REK'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Omega-3 fatty acids', 'description': '2,7 g omega-3 fatty acids / day: Omacor 1 g 1 capsule by mouth 3 times a day for 44 weeks.', 'interventionNames': ['Drug: Omega-3 fatty acids']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo: 1 capsule containing 1 g of olive oil by mouth 3 times a day for 44 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Omega-3 fatty acids', 'type': 'DRUG', 'otherNames': ['Omacor'], 'description': '2,7 g omega-3 fatty acids / day (1 capsule 3 times a day / oral administration)', 'armGroupLabels': ['Omega-3 fatty acids']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Olive oil'], 'description': 'Placebo capsules 3 times a day (oral administration)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0424', 'city': 'Oslo', 'state': '* Other', 'country': 'Norway', 'facility': 'Oslo University Hospital Rikshospitalet', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '0027', 'city': 'Oslo', 'state': 'Oslo County', 'country': 'Norway', 'facility': 'Oslo University Hospital, Rikshospitalet', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Ivar A Eide, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'Pronova BioPharma', 'class': 'INDUSTRY'}, {'name': 'South-Eastern Norway Regional Health Authority', 'class': 'OTHER'}, {'name': 'Aalborg University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Ivar Eide', 'investigatorAffiliation': 'Oslo University Hospital'}}}}