Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-25 @ 7:59 PM
Study NCT ID:
NCT01133795
Status:
COMPLETED
Last Update Posted:
2016-08-18
First Post:
2010-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Midodrine and Albumin for Cirrhotic Patients With Functional Renal Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D006530', 'term': 'Hepatorenal Syndrome'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'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': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008879', 'term': 'Midodrine'}, {'id': 'D000418', 'term': 'Albumins'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-17', 'studyFirstSubmitDate': '2010-05-19', 'studyFirstSubmitQcDate': '2010-05-28', 'lastUpdatePostDateStruct': {'date': '2016-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in glomerular filtration rate assessed by isotopic methods', 'timeFrame': 'at 12 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'changes in arterial pressure as assessed by continuous ambulatory arterial pressure', 'timeFrame': 'at 12 weeks of treatment'}, {'measure': 'changes in plasma renin activity', 'timeFrame': 'at 12 weeks of treatment'}, {'measure': 'changes in aldosterone concentration', 'timeFrame': 'at 12 weeks of treatment'}, {'measure': 'changes in norepinephrine concentration', 'timeFrame': 'at 12 weeks of treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cirrhosis', 'renal failure', 'hepatorenal syndrome', 'albumine', 'midodrine'], 'conditions': ['Cirrhosis', 'Renal Failure']}, 'descriptionModule': {'briefSummary': 'The objective of the study was evaluate the effect of administration of midodrine and albumin on renal function in patients with cirrhosis and creatinine greater than 1,2mg/dl.', 'detailedDescription': 'Twenty patients with cirrhosis and functional renal impairment, defined by a serum creatinine greater than 1,2mg/dl, will be included. Patients will receive daily midodrine at a dose of 10mg tid and 40g of albumin at 15-day interval. The follow-up period will be of 12 weeks. In all patients, liver and renal function, and vasoactive hormones (plasma renin activity, aldosterone, noradrenaline, ADH, endothelin and anf)will be determined at baseline conditions. At this moment, glomerular filtration rate and renal plasma flow determined by isotopic techniques as ambulatory blood pressure monitoring through a 24-hour period will be performed too. All these determinations will be repeated at 4 and 12 weeks. During the study period, just before the albumin infusions, blood will be drawn for creatinine and electrolytes determinations and these will be recorded as well physical examination performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Liver Cirrhosis\n* Serum Creatinine greater than 1,2 mg/dL\n* to have given written informed consent\n\nExclusion Criteria:\n\n* pregnancy\n* Systolic blood pressure above 150mmHg and/or diastolic blood pressure above 90mmHg\n* Previous treatment with transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunts\n* Antibiotic treatment in the previous 7 days before inclusion, except for prophylaxis of spontaneous bacterial peritonitis\n* infection by HIV\n* contraindications for albumin and/or midodrine use'}, 'identificationModule': {'nctId': 'NCT01133795', 'acronym': 'MAFRI', 'briefTitle': 'Midodrine and Albumin for Cirrhotic Patients With Functional Renal Impairment', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Effect of Administration of Intravenous Albumin and Oral Midodrine on Renal Function in Patients With Cirrhosis and Functional Renal Impairment', 'orgStudyIdInfo': {'id': 'MAFRI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Midodrine, Albumin', 'description': 'Midodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks', 'interventionNames': ['Drug: Midodrine plus Albumin']}], 'interventions': [{'name': 'Midodrine plus Albumin', 'type': 'DRUG', 'otherNames': ['Albumin Grifols', 'Gutron'], 'description': 'MIdodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks', 'armGroupLabels': ['Midodrine, Albumin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Villarroel 170,Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Pere Ginès, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinic of Barcelona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief of hepatology unit', 'investigatorFullName': 'Pere Gines', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}