[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100467937":3},{"organization":4,"outcomesModule":7,"designInfo":58,"detailedDescription":70,"studyPopulation":57,"armGroups":71,"interventions":84,"overallOfficials":93,"centralContacts":97,"locations":106,"responsibleParty":396,"collaborators":57,"id":398,"slug":399,"hasResults":400,"nctId":401,"briefTitle":402,"officialTitle":402,"acronym":403,"eligibilityCriteria":404,"healthyVolunteers":400,"sex":405,"minAge":406,"maxAge":407,"enrollmentInfo":408,"targetDuration":57,"studyType":411,"phases":412,"briefSummary":414,"conditions":415,"keywords":417,"overallStatus":109,"whyStopped":57,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":431},{"fullName":5,"class":6},"University Medical Center Groningen","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":57},[9],{"measure":10,"description":11,"timeFrame":12},"Changes in kidney function decline","The primary outcome is the change in kidney function decline (assessed as eGFR slope, in ml\u002Fmin\u002F1.73 m2 per year), calculated with linear mixed models, using all available creatinine values from week 12 until end of treatment between the tolvaptan\u002Fplacebo and tolvaptan\u002FHCT group.","156 weeks",[14,18,21,24,27,30,33,36,39,42,45,48,51,54],{"measure":15,"description":16,"timeFrame":17},"Changes in eGFR from baseline compared to end of study (12 weeks after End of Treatment)","A secondary outcome is the change in eGFR from baseline compared to end of study (12 weeks after end of treatment)","168 weeks",{"measure":19,"description":20,"timeFrame":17},"Incidence of 30% decrease in eGFR, end stage kidney disease (EKSD) or renal death","A secondary outcome is the incidence of a 30% decrease in eGFR, occurrence of end stage kidney disease (EKSD) or renal death during the entire study period (until the end of study (12 weeks after end of treatment)",{"measure":22,"description":23,"timeFrame":12},"Changes in 24-hour urine volume","A secondary outcome is the change in 24-hour urine volume, measured at baseline, week 12, week 48, week 96 and week 156 (end of treatment)",{"measure":25,"description":26,"timeFrame":12},"Quality of life, assessed by the TIPS questionnaire","Changes in Quality of Life measured by the Tolvaptan Impact of Polyuria Scale questionnaire (TIPS) at baseline, week 12, week 48, week 96 and week 156 (end of treatment)",{"measure":28,"description":29,"timeFrame":12},"Quality of life, assessed by the ADPKD-UIS questionnaire","Changes in Quality of Life measured by the ADPKD-Urinary Impact Scale questionnaire (ADPKD-UIS) at baseline, week 12, week 48, week 96 and week 156 (end of treatment)",{"measure":31,"description":32,"timeFrame":12},"Quality of life, assessed by the SF-12 questionnaire","Changes in Quality of Life measured by the Short Form 12 questionnaire (SF-12) at baseline, week 12, week 48, week 96 and week 156 (end of treatment)",{"measure":34,"description":35,"timeFrame":12},"Quality of life, assessed by the EQ-5D questionnaire","Changes in Quality of Life measured by the EuroQol-5 Dimension questionnaire (EQ-5D) at baseline, week 12, week 48, week 96 and week 156 (end of treatment)",{"measure":37,"description":38,"timeFrame":17},"Change in V2RA dose","V2RA dose during each study visit and compared at the end of study visit (12 weeks after end of treatment) between tolvaptan\u002Fplacebo and tolvaptan\u002Fhydrochlorothiazide group",{"measure":40,"description":41,"timeFrame":17},"Change in V2RA discontinuation rate","The V2RA discontinuation rate will be compared at the end of study visit (12 weeks after end of treatment) between tolvaptan\u002Fplacebo and tolvaptan\u002Fhydrochlorothiazide group",{"measure":43,"description":44,"timeFrame":17},"Changes in serum sodium concentration","Changes in serum sodium concentration between tolvaptan\u002Fplacebo and tolvaptan\u002Fhydrochlorothiazide group, measured from baseline until the end of study (12 weeks after end of treatment)",{"measure":46,"description":47,"timeFrame":17},"Changes in serum potassium concentration","Changes in serum potassium concentration between tolvaptan\u002Fplacebo and tolvaptan\u002Fhydrochlorothiazide group, measured from baseline until the end of study (12 weeks after end of treatment)",{"measure":49,"description":50,"timeFrame":17},"Changes in plasma serum calcium concentration","Changes in plasma serum calcium concentration between tolvaptan\u002Fplacebo and tolvaptan\u002Fhydrochlorothiazide group, measured from baseline until the end of study (12 weeks after end of treatment)",{"measure":52,"description":53,"timeFrame":17},"Changes in serum phosphate concentration","Changes in serum phosphate concentration between tolvaptan\u002Fplacebo and tolvaptan\u002Fhydrochlorothiazide group, measured from baseline until the end of study (12 weeks after end of treatment)",{"measure":55,"description":56,"timeFrame":17},"Incidence of (serious) adverse events","Incidence of (serious) adverse events from baseline until the end of study (12 weeks after end of treatment)",null,{"allocation":59,"interventionModel":60,"interventionModelDescription":61,"primaryPurpose":62,"observationalModel":57,"timePerspective":57,"maskingInfo":63},"RANDOMIZED","PARALLEL","An investigator driven, multicenter, placebo-controlled, randomized clinical trial.","TREATMENT",{"masking":64,"maskingDescription":57,"whoMasked":65},"QUADRUPLE",[66,67,68,69],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Aims: The main objectives of the current study are to prospectively test whether HCT co-treatment can improve V2RA efficacy (slowing kidney function decline) and tolerability (quality of life) in PKD.\n\nStudy design: Investigator driven randomized placebo-controlled multicenter trial\n\nStudy population: 300 ADPKD patients of ≥18 years, with an eGFR of \\> 25 mL\u002Fmin\u002F1.73m2, on stable treatment with the highest tolerated dose of V2RA\n\nIntervention: Oral HCT 25 mg once daily or matching placebo for a total of 156 weeks. The randomization ratio will be 1:1.\n\nStudy visit schedule: study measurements will be performed during 12-weekly visits (which is routine care for V2RA treated patients), except for one additional study visit (or telephone call) 2 weeks after the start of treatment\n\nPrimary study outcome: Slope of kidney function decline (measured by eGFR)",[72,78],{"label":73,"type":74,"description":75,"interventionNames":76},"Hydrochlorothiazide","ACTIVE_COMPARATOR","Oral hydrochlorothiazide 25mg, once daily, for a total of 156 weeks",[77],"Drug: Hydrochlorothiazide 25 mg",{"label":79,"type":80,"description":81,"interventionNames":82},"Placebo","PLACEBO_COMPARATOR","Matching oral placebo, once daily, for a total of 156 weeks. The placebo is inert.",[83],"Drug: Placebo",[85,90],{"type":86,"name":87,"description":88,"armGroupLabels":89,"otherNames":57},"DRUG","Hydrochlorothiazide 25 mg","An oral capsule containing 25mg of hydrochlorothiazide",[73],{"type":86,"name":79,"description":91,"armGroupLabels":92,"otherNames":57},"A matching oral capsule containing placebo",[79],[94],{"name":95,"affiliation":5,"role":96},"Prof. dr. R.T. Gansevoort","PRINCIPAL_INVESTIGATOR",[98,103],{"name":99,"role":100,"phone":101,"phoneExt":57,"email":102},"Dr. E Meijer","CONTACT","+31 50 3616161","esther.meijer@umcg.nl",{"name":104,"role":100,"phone":57,"phoneExt":57,"email":105},"T. Bais, MD","t.bais@umcg.nl",[107,122,133,148,159,170,183,194,205,216,227,240,251,262,273,286,296,307,320,331,339,350,363,374,385],{"facility":108,"status":109,"city":110,"state":57,"zip":57,"country":111,"countryCode":112,"cosmosGeoPoint":113,"geoPoint":118,"contacts":119},"Uniklinikum Graz","RECRUITING","Graz","Austria","AT",{"type":114,"coordinates":115},"Point",[116,117],15.44197,47.06733,{"lat":117,"lon":116},[120],{"name":121,"role":100,"phone":57,"phoneExt":57,"email":57},"Werner Ribitsch, dr.",{"facility":123,"status":109,"city":124,"state":57,"zip":57,"country":111,"countryCode":112,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Medizinische Universität Innsbruck","Innsbruck",{"type":114,"coordinates":126},[127,128],11.39454,47.26266,{"lat":128,"lon":127},[131],{"name":132,"role":100,"phone":57,"phoneExt":57,"email":57},"Michael Rudnicki, prof.",{"facility":134,"status":109,"city":135,"state":57,"zip":57,"country":136,"countryCode":137,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Universitair Ziekenhuis Antwerpen (UZA)","Antwerp","Belgium","BE",{"type":114,"coordinates":139},[140,141],4.40026,51.22047,{"lat":141,"lon":140},[144,146],{"name":145,"role":100,"phone":57,"phoneExt":57,"email":57},"Paulien Lievens",{"name":147,"role":96,"phone":57,"phoneExt":57,"email":57},"Rowena Vleut",{"facility":149,"status":109,"city":150,"state":57,"zip":57,"country":136,"countryCode":137,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Cliniques Universitaires Saint-Luc","Brussels",{"type":114,"coordinates":152},[153,154],4.34878,50.85045,{"lat":154,"lon":153},[157],{"name":158,"role":100,"phone":57,"phoneExt":57,"email":57},"Prof. Nathalie Demoulin",{"facility":160,"status":109,"city":161,"state":57,"zip":57,"country":136,"countryCode":137,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"University Hospital Leuven","Leuven",{"type":114,"coordinates":163},[164,165],4.70093,50.87959,{"lat":165,"lon":164},[168],{"name":169,"role":100,"phone":57,"phoneExt":57,"email":57},"Prof dr. B. Bammens",{"facility":171,"status":109,"city":172,"state":57,"zip":57,"country":173,"countryCode":174,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"Hôpital Pellegrin (CHU Bordeaux)","Bordeaux","France","FR",{"type":114,"coordinates":176},[177,178],-0.58046,44.84124,{"lat":178,"lon":177},[181],{"name":182,"role":100,"phone":57,"phoneExt":57,"email":57},"Claire Rigothier",{"facility":184,"status":109,"city":185,"state":57,"zip":57,"country":173,"countryCode":174,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"Hospital La Cavale Blanche","Brest",{"type":114,"coordinates":187},[188,189],-4.48628,48.39029,{"lat":189,"lon":188},[192],{"name":193,"role":100,"phone":57,"phoneExt":57,"email":57},"Prof. dr. E. Cornec-Le Gall",{"facility":195,"status":109,"city":196,"state":57,"zip":57,"country":173,"countryCode":174,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"Centre Hôpital Universitaire de Lyon","Lyon",{"type":114,"coordinates":198},[199,200],4.84789,45.74906,{"lat":200,"lon":199},[203],{"name":204,"role":100,"phone":57,"phoneExt":57,"email":57},"Sandrine Lemoine",{"facility":206,"status":109,"city":207,"state":57,"zip":57,"country":173,"countryCode":174,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"Hôpitaux de Brabois (CHRU)","Nancy",{"type":114,"coordinates":209},[210,211],6.18496,48.68439,{"lat":211,"lon":210},[214],{"name":215,"role":100,"phone":57,"phoneExt":57,"email":57},"Adrien Flahault",{"facility":217,"status":109,"city":218,"state":57,"zip":57,"country":173,"countryCode":174,"cosmosGeoPoint":219,"geoPoint":223,"contacts":224},"Necker-Enfants Malades Hospital","Paris",{"type":114,"coordinates":220},[221,222],2.3488,48.85341,{"lat":222,"lon":221},[225],{"name":226,"role":100,"phone":57,"phoneExt":57,"email":57},"Prof dr. B. Knebelmann",{"facility":228,"status":109,"city":229,"state":57,"zip":57,"country":230,"countryCode":231,"cosmosGeoPoint":232,"geoPoint":236,"contacts":237},"Charité University Hospital","Berlin","Germany","DE",{"type":114,"coordinates":233},[234,235],13.41053,52.52437,{"lat":235,"lon":234},[238],{"name":239,"role":100,"phone":57,"phoneExt":57,"email":57},"Prof J. Halbritter",{"facility":241,"status":109,"city":242,"state":57,"zip":57,"country":230,"countryCode":231,"cosmosGeoPoint":243,"geoPoint":247,"contacts":248},"University Hospital Cologne","Cologne",{"type":114,"coordinates":244},[245,246],6.95,50.93333,{"lat":246,"lon":245},[249],{"name":250,"role":100,"phone":57,"phoneExt":57,"email":57},"Prof. dr. R.U. Müller",{"facility":252,"status":109,"city":253,"state":57,"zip":57,"country":230,"countryCode":231,"cosmosGeoPoint":254,"geoPoint":258,"contacts":259},"Med. Klinik und Poliklinik III, Universitätsklinikum Dresden.","Dresden",{"type":114,"coordinates":255},[256,257],13.73832,51.05089,{"lat":257,"lon":256},[260],{"name":261,"role":100,"phone":57,"phoneExt":57,"email":57},"Alexander Paliege",{"facility":263,"status":109,"city":264,"state":57,"zip":57,"country":230,"countryCode":231,"cosmosGeoPoint":265,"geoPoint":269,"contacts":270},"Universitätsklinikum Leipzig","Leipzig",{"type":114,"coordinates":266},[267,268],12.37129,51.33962,{"lat":268,"lon":267},[271],{"name":272,"role":100,"phone":57,"phoneExt":57,"email":57},"Friederike Petzold, dr.",{"facility":274,"status":109,"city":275,"state":57,"zip":57,"country":276,"countryCode":277,"cosmosGeoPoint":278,"geoPoint":282,"contacts":283},"Amsterdam University Medical Center","Amsterdam","Netherlands","NL",{"type":114,"coordinates":279},[280,281],4.88969,52.37403,{"lat":281,"lon":280},[284],{"name":285,"role":100,"phone":57,"phoneExt":57,"email":57},"Prof dr. M. van Ittersum",{"facility":5,"status":109,"city":287,"state":57,"zip":57,"country":276,"countryCode":277,"cosmosGeoPoint":288,"geoPoint":292,"contacts":293},"Groningen",{"type":114,"coordinates":289},[290,291],6.56667,53.21917,{"lat":291,"lon":290},[294],{"name":295,"role":100,"phone":57,"phoneExt":57,"email":105},"dr. T Bais",{"facility":297,"status":109,"city":298,"state":57,"zip":57,"country":276,"countryCode":277,"cosmosGeoPoint":299,"geoPoint":303,"contacts":304},"Erasmus University Medical Center","Rotterdam",{"type":114,"coordinates":300},[301,302],4.47917,51.9225,{"lat":302,"lon":301},[305],{"name":306,"role":100,"phone":57,"phoneExt":57,"email":57},"dr. M. Salih",{"facility":308,"status":109,"city":309,"state":57,"zip":57,"country":310,"countryCode":311,"cosmosGeoPoint":312,"geoPoint":316,"contacts":317},"Hospital Universitario Mancha Centro","Alcázar de San Juan","Spain","ES",{"type":114,"coordinates":313},[314,315],-3.20827,39.39011,{"lat":315,"lon":314},[318],{"name":319,"role":100,"phone":57,"phoneExt":57,"email":57},"Rebeca Garcia",{"facility":321,"status":109,"city":322,"state":57,"zip":57,"country":310,"countryCode":311,"cosmosGeoPoint":323,"geoPoint":327,"contacts":328},"Fundación Puigvert","Barcelona",{"type":114,"coordinates":324},[325,326],2.15899,41.38879,{"lat":326,"lon":325},[329],{"name":330,"role":100,"phone":57,"phoneExt":57,"email":57},"Prof. dr. R. Torra",{"facility":332,"status":109,"city":322,"state":57,"zip":57,"country":310,"countryCode":311,"cosmosGeoPoint":333,"geoPoint":335,"contacts":336},"Hospital Universitario Vall D'Hebron",{"type":114,"coordinates":334},[325,326],{"lat":326,"lon":325},[337],{"name":338,"role":100,"phone":57,"phoneExt":57,"email":57},"Laia Sans",{"facility":340,"status":109,"city":341,"state":57,"zip":57,"country":310,"countryCode":311,"cosmosGeoPoint":342,"geoPoint":346,"contacts":347},"La Fundación Jiménez Díaz","Madrid",{"type":114,"coordinates":343},[344,345],-3.70256,40.4165,{"lat":345,"lon":344},[348],{"name":349,"role":100,"phone":57,"phoneExt":57,"email":57},"María Vanessa Pérez Gómez",{"facility":351,"status":109,"city":352,"state":57,"zip":57,"country":353,"countryCode":354,"cosmosGeoPoint":355,"geoPoint":359,"contacts":360},"Universitätsspital Bern (Inselsspital)","Bern","Switzerland","CH",{"type":114,"coordinates":356},[357,358],7.44744,46.94809,{"lat":358,"lon":357},[361],{"name":362,"role":100,"phone":57,"phoneExt":57,"email":57},"Daniel Fuster",{"facility":364,"status":109,"city":365,"state":57,"zip":57,"country":353,"countryCode":354,"cosmosGeoPoint":366,"geoPoint":370,"contacts":371},"Hôpital Fribourgeois (HFR)","Fribourg",{"type":114,"coordinates":367},[368,369],7.15128,46.80237,{"lat":369,"lon":368},[372],{"name":373,"role":100,"phone":57,"phoneExt":57,"email":57},"Olivier Bonny",{"facility":375,"status":109,"city":376,"state":57,"zip":57,"country":353,"countryCode":354,"cosmosGeoPoint":377,"geoPoint":381,"contacts":382},"Hôpitaux Universitaires de Genève (HUG)","Geneva",{"type":114,"coordinates":378},[379,380],6.14569,46.20222,{"lat":380,"lon":379},[383],{"name":384,"role":100,"phone":57,"phoneExt":57,"email":57},"Fadi Haidar",{"facility":386,"status":109,"city":387,"state":57,"zip":57,"country":353,"countryCode":354,"cosmosGeoPoint":388,"geoPoint":392,"contacts":393},"Universitätsspital Zürich (USZ)","Zurich",{"type":114,"coordinates":389},[390,391],8.55,47.36667,{"lat":391,"lon":390},[394],{"name":395,"role":100,"phone":57,"phoneExt":57,"email":57},"Andrea Viecelli",{"type":397,"investigatorFullName":57,"investigatorTitle":57,"investigatorAffiliation":57,"oldNameTitle":57,"oldOrganization":57},"SPONSOR","100467937","phase-3-hydrochlorothiazide-to-protect-polycystic-kidney-disease-patients-and-improve-their-quality-of-life-100467937",false,"NCT05373264","HYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of Life","HYDRO-PROTECT","Inclusion Criteria:\n\n* ADPKD diagnosis (modified Ravine criteria)\n* ≥18 years old\n* eGFR \\> 25 mL\u002Fmin\u002F1.73m2\n* On stable treatment with the highest tolerated dose of V2RA for a minimum of 3 months\n\nExclusion Criteria:\n\n* Known intolerance to hydrochlorothiazide\n* Use of any diuretic\n* Orthostatic hypotension complaints or blood pressure \\\u003C105\u002F65mmHg during screening visit\n* Uncontrolled hypertension (blood pressure \\>160\u002F100mmHg)\n* Hypokalemia (\\\u003C3.5 mmol\u002FL)\n* History of active gout on maintenance preventive treatment for gout (allopurinol, desuric and\u002For colchicine), defined as ≥2 episodes during the last year\n* History of skin cancer (basal cell, squamous cell and melanoma)","ALL","18 Years","80 Years",{"count":409,"type":410},300,"ESTIMATED","INTERVENTIONAL",[413],"PHASE3","Autosomal dominant polycystic kidney disease (ADPKD) is characterized by progressive formation of renal cysts which ultimately lead to a loss of renal function.\n\nTolvaptan (a V2R antagonist) is currently the only effective treatment for preserving renal function in ADPKD. However, side-effects such as polyuria limit its tolerability and thereby the therapeutic potential. This study will test whether co-administration with hydochlorothiazide can improve V2RA efficacy (slowing kidney function decline) and tolerability (quality of life) in ADPKD. Approximately 300 patients will be enrolled.",[416],"ADPKD",[416,418,73,419,420,421],"Tolvaptan","Quality of Life","Side effects","Polyuria","2026-08-21",{"date":424,"type":425},"2026-08-25","ACTUAL",{"date":427,"type":425},"2024-07-31",{"date":429,"type":410},"2031-07",{"name":5,"class":6},25]