Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT00328302
Status:
UNKNOWN
Last Update Posted:
2006-05-19
First Post:
2006-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diabetes Type 1, Treatment Study Atacand/Placebo After Kidney Biopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C081643', 'term': 'candesartan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 13}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2000-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2000-06', 'completionDateStruct': {'date': '2006-04'}, 'lastUpdateSubmitDate': '2006-05-18', 'studyFirstSubmitDate': '2006-05-18', 'studyFirstSubmitQcDate': '2006-05-18', 'lastUpdatePostDateStruct': {'date': '2006-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Basement membrane thickness'}, {'measure': 'Mesangial expansion'}], 'secondaryOutcomes': [{'measure': 'Hypertension'}, {'measure': 'Microalbuminuria'}, {'measure': 'Kidney Function'}, {'measure': '24 hour ambulatory blood pressure'}]}, 'conditionsModule': {'keywords': ['Diabetes', 'Kidney function', '24 ambulatory blood pressure', 'Kidney biopsy'], 'conditions': ['Diabetes, Type I']}, 'referencesModule': {'references': [{'pmid': '18270751', 'type': 'DERIVED', 'citation': 'Perrin NE, Jaremko GA, Berg UB. The effects of candesartan on diabetes glomerulopathy: a double-blind, placebo-controlled trial. Pediatr Nephrol. 2008 Jun;23(6):947-54. doi: 10.1007/s00467-008-0745-x.'}]}, 'descriptionModule': {'briefSummary': 'The type 1 diabetes patients who were still normoalbuminuric and normotensive, after 17 years duration and a second research kidney biopsy, could enter the double blind treatment study of Atacand or Placebo.\n\nThe treatment study continues for five years treatment and ends with a third kidney biopsy.\n\nThe study hypothesis is that the effect of ARB during 5 years on the histopathology are more pronounced than the effect on histopathology of placebo.', 'detailedDescription': '46 patients performed a first kidney biopsy between 1992-1994. After 6 years 29 accepted to perform a second biopsy. During the follow-up 10 patients developed complications i.e. hypertension or microalbuminuria. 7 of the patients got treatment during follow up and 3 started the treatment after the second biopsy. 19 patients with two kidney biopsies were still normoalbuminuric and normotensive. 13 of them entered the double-blind treatment study of Atacand or Placebo. 6 denied to participate in the treatment study.\n\nThe treatment study will continue for 5 years and will end with a third kidney biopsy. Also the rest of the patients that have done 2 kidney biopsies will be asked to perform a third biopsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetes type 1 patient\n* Normotensive\n* Normoalbuminuric\n* Signed informed consent\n* Female and male\n* Over 17 years of age\n* Diabetes duration over 10 years\n\nExclusion Criteria:\n\n* Hypertension\n* Microalbuminuria\n* Pregnancy\n* Lactation\n* Reduced kidney function\n* Artery stenosis\n* Kidney transplantation\n* Allergy to the medication in the study\n* Reduced liver function\n* Alcohol or drug abuse\n* Participation in another drug or clinical test during last 30 days\n* Severe diseases i.e. malignancy\n* Previously enrolment of the present study'}, 'identificationModule': {'nctId': 'NCT00328302', 'briefTitle': 'Diabetes Type 1, Treatment Study Atacand/Placebo After Kidney Biopsy', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Studies of Early Diabetic Glomerulopathy-the Relation Between Histopathology, Kidney Function and Metabolic Control. Natural History and Effect of ARB', 'orgStudyIdInfo': {'id': 'SH-AHM-0044-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Candesartan', 'type': 'DRUG'}, {'name': 'Placebo', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '141 86', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Childrens Hospital, Karolinska University Hospital, Huddinge', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Nina ES Perrin, PhD-student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska University Hospital, Huddinge, B57, Childrens Hospital, 141 86 Stockholm'}, {'name': 'Ulla B Berg, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Karolinska University Hospital, B57, Childrens Hospital, 141 86 Stockholm, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}]}}}