Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT07271420
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Blood Pressure Control With Thiazide Diuretics in Peritoneal Dialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006852', 'term': 'Hydrochlorothiazide'}], 'ancestors': [{'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Following written informed consent, participants entered the treatment arm, receiving oral hydrochlorothiazide once daily on top of their standard of treatment for 90 days. This was followed by a 14-day washout period, after which participants entered a 90-day control period.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-11-26', 'studyFirstSubmitQcDate': '2025-11-26', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in systolic and diastolic blood pressure', 'timeFrame': '90 days'}], 'secondaryOutcomes': [{'measure': 'Changes in body weight', 'timeFrame': '90 days'}, {'measure': 'Changes in body composition measured by bio impedance spectroscopy', 'timeFrame': '90 days'}, {'measure': 'Change in urinary fractional excretion of sodium', 'timeFrame': '90 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Thiazides diuretics', 'End stage kidney disease', 'Peritoneal dialysis'], 'conditions': ['Hypertension', 'Peritoneal Dialysis', 'End Stage Kidney Disease (ESRD)']}, 'referencesModule': {'references': [{'pmid': '34739197', 'type': 'BACKGROUND', 'citation': 'Agarwal R, Sinha AD, Cramer AE, Balmes-Fenwick M, Dickinson JH, Ouyang F, Tu W. Chlorthalidone for Hypertension in Advanced Chronic Kidney Disease. N Engl J Med. 2021 Dec 30;385(27):2507-2519. doi: 10.1056/NEJMoa2110730. Epub 2021 Nov 5.'}, {'pmid': '35894274', 'type': 'BACKGROUND', 'citation': 'Ali S, Navaneethan SD, Virani SS, Gregg LP. Revisiting diuretic choice in chronic kidney disease. Curr Opin Nephrol Hypertens. 2022 Sep 1;31(5):406-413. doi: 10.1097/MNH.0000000000000814. Epub 2022 Jul 11.'}, {'pmid': '36400564', 'type': 'BACKGROUND', 'citation': 'An J, Kurella Tamura M, Odden MC, Ni L, Thomas IC, Montez-Rath ME, Sim JJ. Prevalence of Apparent Treatment-Resistant Hypertension in Chronic Kidney Disease in Two Large US Health Care Systems. Clin J Am Soc Nephrol. 2022 Oct;17(10):1457-1466. doi: 10.2215/CJN.04110422. Epub 2022 Sep 9.'}, {'pmid': '36519768', 'type': 'BACKGROUND', 'citation': 'Chan GC, Ng JK, Chow KM, Cheng PM, Law MC, Leung CB, Li PK, Szeto CC. Polypharmacy Predicts Onset and Transition of Frailty, Malnutrition, and Adverse Outcomes in Peritoneal Dialysis Patient. J Nutr Health Aging. 2022;26(12):1054-1060. doi: 10.1007/s12603-022-1859-8.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the blood pressure lowering effects of thiazide diuretics in patients on peritoneal dialysis', 'detailedDescription': 'This prospective, single-center treatment-withdrawal crossover study enrolled 10 patients on chronic peritoneal dialysis (PD) and uncontrolled hypertension (SBP \\>140 mmHg and/or DBP \\>90 mmHg).\n\nFollowing written informed consent, participants entered the treatment arm, receiving oral hydrochlorothiazide once daily on top of their standard of treatment for 90 days. This was followed by a 14-day washout period, after which participants entered a 90-day control period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients on chronic peritoneal dialysis, with uncontrolled hypertension (SBP \\>140 mmHg and/or DBP \\>90 mmHg)\n\nExclusion Criteria:\n\n* Patients with a life expectancy of less than 3 months, planned conversion to hemodialysis, or scheduled kidney transplantation within 3 months'}, 'identificationModule': {'nctId': 'NCT07271420', 'briefTitle': 'Blood Pressure Control With Thiazide Diuretics in Peritoneal Dialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Blood Pressure Control With Thiazide Diuretics in Peritoneal Dialysis Patients', 'orgStudyIdInfo': {'id': 'CREC2019.580'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Thiazides treatment arm', 'interventionNames': ['Drug: Hydrochlorothiazide 25mg once per day']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm'}], 'interventions': [{'name': 'Hydrochlorothiazide 25mg once per day', 'type': 'DRUG', 'description': 'Thiazides diuretics', 'armGroupLabels': ['Thiazides treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'CC Szeto, MD, FRCP', 'role': 'CONTACT', 'email': 'ccszeto@cuhk.edu.hk', 'phone': '0085235052211'}], 'facility': 'Prince of Wales Hospital. The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Gordon Chan, MD, MRCP', 'role': 'CONTACT', 'email': 'cck295@ha.org.hk', 'phone': '0085235052211'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Additional consent will need to be obtained from the participants'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Chan Chun Kau Gordon', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}