Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-03-12 @ 6:54 AM
Study NCT ID:
NCT03102632
Status:
COMPLETED
Last Update Posted:
2023-10-19
First Post:
2017-03-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016891', 'term': 'Polycystic Kidney, Autosomal Dominant'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The radiologist measuring kidney volumes will be masked to the study condition.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Participants will have a period of usual fluid intake and a period of increased water intake over the course of the study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-17', 'studyFirstSubmitDate': '2017-03-27', 'studyFirstSubmitQcDate': '2017-03-30', 'lastUpdatePostDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in total kidney volume, as measured from magnetic resonance imaging', 'timeFrame': '18 months', 'description': 'Total kidney volumes will be measured before and after the period of high water intake. Kidney volume growth with high water intake will be compared to baseline kidney volume growth.'}], 'secondaryOutcomes': [{'measure': 'Kidney function change', 'timeFrame': '18 months', 'description': 'Blood creatinine levels will be measured and compared before and after the high water intake period.'}, {'measure': 'Change in urine and blood markers of response to high water intake', 'timeFrame': '18 months.', 'description': 'Blood and urine biomarkers of response to high water intake will be measured before and after the period of high water intake.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autosomal Dominant Polycystic Kidney']}, 'referencesModule': {'references': [{'pmid': '38556640', 'type': 'DERIVED', 'citation': 'Dev H, Zhu C, Barash I, Blumenfeld JD, He X, RoyChoudhury A, Wu A, Prince MR. Feasibility of Water Therapy for Slowing Autosomal Dominant Polycystic Kidney Disease Progression. Kidney360. 2024 May 1;5(5):698-706. doi: 10.34067/KID.0000000000000428. Epub 2024 Apr 1.'}]}, 'descriptionModule': {'briefSummary': 'Patients affected by Autosomal Dominant Polycystic Kidney Disease (ADPKD) need a safe and effective long-term treatment regimen. Unfortunately, there are still no disease-specific treatment for ADPKD approved in the US. A rational step towards identifying such agents is to test therapies that have a proven safety profile with mechanisms of action that can counter the disease progression.\n\nThe purpose of this study is to investigate whether drinking increased amounts of water (water loading) might slow down polycystic kidney growth or kidney function decline. Water loading can cause the suppression of a pathway that causes fluid buildup and cyst growth. High water intake has been safely used in the clinical setting, such as in the case of kidney stone therapy. New York State tap water is widely available and safe, making it highly cost-effective as well.', 'detailedDescription': 'The study will involve 11 visits to the study site over 19 months. Participants will need to follow specific dietary and fluid recommendations. There will be physical examinations and medical history assessments at each visit. Testing will include undergoing magnetic resonance imaging (MRI), blood and urine tests. Study participants will be compensated for their time. Detailed study procedures will be reviewed upon contact with the study team.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pre-existing diagnosis of Autosomal Dominant Polycystic Kidney Disease\n* estimated glomerular filtration rate of 40 ml/min or greater\n* urine osmolality \\> 400 mOsm/L\n\nExclusion Criteria:\n\n* estimated glomerular filtration rate less than 40 ml/min\n* low blood sodium levels\n* syndrome of inappropriate diuretic hormone\n* use of thiazide diuretics or selective serotonin reuptake inhibitors (SSRIs)\n* use of tolvaptan, another vasopressin receptor antagonist, vasopressin agonists or dDAVP\n* contraindications to magnetic resonance imaging (MRI) (pacemakers, defibrillators, implanted electronic devices, metallic foreign body)'}, 'identificationModule': {'nctId': 'NCT03102632', 'briefTitle': 'A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'The Rogosin Institute'}, 'officialTitle': 'A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney Disease', 'orgStudyIdInfo': {'id': '1701017921'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Water Intake', 'description': 'For the first 6 months of the study, the participants will continue their usual water intake.'}, {'type': 'EXPERIMENTAL', 'label': 'High Water Intake', 'description': 'After a 6 month period of usual water intake, a high water intake daily amount will be prescribed for 1 year.', 'interventionNames': ['Other: High Water Intake']}], 'interventions': [{'name': 'High Water Intake', 'type': 'OTHER', 'description': "After 6 months of usual, unchanged diet and fluid intake, participants will be asked to increase the daily fluid intake based on the principal investigator's prescription. The actual amount of extra water prescribed will depend on the results of the participant's 24 hour urine test.", 'armGroupLabels': ['High Water Intake']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'The Rogosin Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Martin Prince, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Rogosin Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}