Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-28 @ 6:01 AM
Study NCT ID:
NCT01348035
Status:
COMPLETED
Last Update Posted:
2018-03-15
First Post:
2011-05-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Water Drinking on PKD Progression.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016891', 'term': 'Polycystic Kidney, Autosomal Dominant'}, {'id': 'D018450', 'term': 'Disease Progression'}, {'id': 'D003919', 'term': 'Diabetes Insipidus'}], 'ancestors': [{'id': 'D007690', 'term': 'Polycystic Kidney Diseases'}, {'id': 'D052177', 'term': 'Kidney Diseases, Cystic'}, {'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': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D000072661', 'term': 'Ciliopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-14', 'studyFirstSubmitDate': '2011-05-03', 'studyFirstSubmitQcDate': '2011-05-04', 'lastUpdatePostDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total kidney volume (TKV) measured by magnetic resonance imaging (MRI).', 'timeFrame': 'One year (12 months) and pre-study period.', 'description': 'The relationship between urine volume (and urine osmolality) and change of TKV. TKV slopes are compared between pre-study and study period.'}], 'secondaryOutcomes': [{'measure': 'Glomerular filtration rate (GFR) estimated by plasma creatinine and cystatin C.', 'timeFrame': 'One year (12 months)', 'description': 'The relationship between urine volume (and urine osmolality) and change of GFR.'}, {'measure': 'Plasma arginine vasopressin (AVP, Copeptin) level.', 'timeFrame': '4-8-12 months', 'description': 'The relationship between urine volume (osmolality) and plasma AVP.'}, {'measure': 'Quality of life (QOL) questionnaire.', 'timeFrame': '4-8-12 months', 'description': 'The relationship between QOL and urine volume.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Autosomal Dominant Polycystic Kidney Disease.', 'Arginine vasopressin', 'Total Kidney Volume', 'Glomerular Filtration Rate'], 'conditions': ['Autosomal Dominant Polycystic Kidney Disease', 'Disease Progression']}, 'descriptionModule': {'briefSummary': 'This is a prospective 5-year study to compare the change in total kidney volume (TKV) before and after tolvaptan therapy, as the primary endpoint, in patients with ADPKD.', 'detailedDescription': 'Tolvaptan was approved in Japan for the treatment of autosomal dominant polycystic kidney disease (ADPKD) in March 2014. This is a prospective 5-year study to compare the change in total kidney volume (TKV) before and after tolvaptan therapy, as the primary endpoint, in patients with ADPKD. Study results will be summarized, analyzed, and compiled into a research paper at 3 years (data cut-off, March 31, 2018) and at 5 years (data cut-off, March 31, 2020)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients who visit Kyorin University Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients with ADPKD\n* The patients who consent to the study protocol\n* Estimated glomerular filtration rate (eGFR) or Creatinine Clearance greater than 50ml/min/1.73m2\n\nExclusion Criteria:\n\n* Patients who might be danger to drink large amount of water such as having heart failure or past history of cerebrovascular or cardiovascular disorders.\n* The patients who take habitual medication which affects the AVP action such as selective serotonin reuptake inhibitors (SSRI ), tricyclic antidepressants or diuretics.\n* The patients who is considered inappropriate by physicians.'}, 'identificationModule': {'nctId': 'NCT01348035', 'acronym': 'ESWP', 'briefTitle': 'Efficacy Study of Water Drinking on PKD Progression.', 'organization': {'class': 'OTHER', 'fullName': 'Kyorin University'}, 'officialTitle': 'Efficacy Study of Long-term Water Intake on the Progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD).', 'orgStudyIdInfo': {'id': 'KYR-003-PKD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Water Load Group', 'description': 'Water load group: 2.5 \\~ 3 L water intake daily for 12 months (50ml/Kg body weight/day). When large amount water intake is not sustainable, patients can reduce the amount of water intake to the levels as much as large he or she can sustain.'}, {'label': 'Non-Water Loaded Group', 'description': 'Non-water load group: The patients are free to access water intake, as they like.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '181-8611', 'city': 'Mitaka', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Department of Urology, Kyorin University Hospital', 'geoPoint': {'lat': 35.68361, 'lon': 139.56002}}], 'overallOfficials': [{'name': 'Eiji Higashihara, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyorin University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyorin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Eiji Higashihara, MD', 'investigatorAffiliation': 'Kyorin University'}}}}