Ignite Creation Date:
2025-12-25 @ 12:11 AM
Ignite Modification Date:
2026-02-22 @ 10:36 PM
Study NCT ID:
NCT06435858
Status:
RECRUITING
Last Update Posted:
2025-09-12
First Post:
2024-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-term Effects of an SGLT2 Inhibitor on Divalent Ions in 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570240', 'term': 'empagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Investigator-initiated randomised, single-blind, placebo-controlled, cross-over study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2024-05-24', 'studyFirstSubmitQcDate': '2024-05-24', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Outcome', 'timeFrame': 'After a two week intervention', 'description': '\\- Calcium, phosphate, magnesium excretion'}], 'secondaryOutcomes': [{'measure': 'Secondary Outcome', 'timeFrame': 'After a two week intervention', 'description': '\\- diuresis (24-hour urine volume, 24-hour creatinine, ketonuria, osmolarity, urinary pH) - tubular handling of other electrolytes (Na, K, Cl) - inflammation metabolism (CRP, hemoglobin?) - kidney function (creatinine, uric acid, urea, hemoglobin?) - effect on standardized blood pressure (assessed every two weeks) - bone metabolism (FGF23, PTH, 25-(OH)-D3) - tolerability (patient-reported side effects (nycturia, urinary urgency, lightheadedness, syncope) - safety (bacteriuria, urinary tract infection requiring antibiotic treatment, genital mycosis)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['phosphate', 'calcium', 'magnesium', 'Empagliflozin', 'ADPKD'], 'conditions': ['Autosomal Dominant Polycystic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '39356039', 'type': 'DERIVED', 'citation': 'St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to better understand electrolyte handling in patients with autosomal dominant polycystic kidney disease treated with the SGLT2 inhibitor Empagliflozin.\n\nPatients will be randomized into two groups and take Empagliflozin or a Placebo for 2 weeks with a wash-out period of 2 weeks. The primary outcome is tubular handling of the divalent ions calcium, phosphate and magnesium. Secondary outcomes include diuresis, safety and tolerability.', 'detailedDescription': 'This investigator-initiated randomised, single-blind, placebo-controlled cross-over study aims to better understand tubular electrolyte handling of divalent ions in patients with autosomal dominant polycystic kidney disease treated with the SGLT2 inhibitor Empagliflozin.\n\nAfter randomization, at week 0, participants collect 24-hour urine sample and a patient visit to assess vitals and blood tests takes place. After this visit, period 1 starts with a 2-week treatment of either Empagliflozin 10mg or Placebo.\n\nAt week 2, the second 24-hour-urine sample and 2. patient visit and blood test take place. After this visit, wash-out period for 2 weeks starts where no study drug will be administered At week 4, the period 2, the crossover-period starts for an additional 2 weeks. At week 6; a final and third 24-hour urine sample, clinical visit and blood test takes place.\n\nAt week 3 \\& 7, a phone consultation will assess safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Patients 18-75 years old with ADPKD, defined according to international diagnostic and classification criteria14, treated at Cantonal Hospital Graubünden (KSGR) and the University Hospital Zürich (USZ) independent of baseline treatment with the vasopressin receptor antagonist Tolvaptan\n* Informed consent as documented by signature\n\nExclusion Criteria:\n\n* \\- renal replacement therapy or kidney allograft recipient\n* chronic kidney disease CKD KDIGO Stage G4 (eGFR under 30ml/min/1.73m2)\n* patients younger 18 years of age\n* Diabetes mellitus type 1\n* recurrent urinary tract infections (UTI) defined as more than 3 infections requiring antibiotic treatment or over 1 requiring hospitalization/year.\n* Patients with uncontrolled hypertension (defined as ambulatory systolic BP over 180mmHg), liver cirrhosis (Child Pugh B and C)\n* Patients not able or not willing to stop the following medications during the study period of participation in the trial:\n* Thiazide diuretics\n* Carbonic anhydrase inhibitors\n* Sodium bicarbonate\n* 1, 25 (OH) vitamin D (calcitriol)\n* Bisphosphonate, denosumab, teriparatide\n* Pregnant or lactating women\n* Known allergy to study drug\n* Inability to understand and follow the protocol'}, 'identificationModule': {'nctId': 'NCT06435858', 'acronym': 'SIDIA', 'briefTitle': 'Short-term Effects of an SGLT2 Inhibitor on Divalent Ions in Autosomal Dominant Polycystic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Cantonal Hospital Graubuenden'}, 'officialTitle': 'Short-term Effects of an SGLT2 Inhibitor on Divalent Ions in Autosomal Dominant Polycystic Kidney Disease', 'orgStudyIdInfo': {'id': '2024-00070'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Empagliflozin 10mg', 'interventionNames': ['Drug: Empagliflozin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Empagliflozin', 'type': 'DRUG', 'description': 'Empagliflozin 10mg', 'armGroupLabels': ['Intervention']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo capsule', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Thomas Schachtner, MD', 'role': 'CONTACT'}], 'facility': 'University Hospital Zurich, Division of Nephrology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': '7000', 'city': 'Chur', 'state': 'Kanton Graubünden', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Patrick Hofmann, MD', 'role': 'CONTACT', 'email': 'medizin@ksgr.ch'}, {'name': 'Lorena Roth, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cantonal Hospital Graubuenden', 'geoPoint': {'lat': 46.84986, 'lon': 9.53287}}], 'centralContacts': [{'name': 'Patrick Hofmann, MD', 'role': 'CONTACT', 'email': 'hofmannpatrick@bluewin.ch', 'phone': '+4181 256 6305'}, {'name': 'Thomas Fehr, MD', 'role': 'CONTACT', 'email': 'medizin@ksgr.ch', 'phone': '+4181 256 6305'}], 'overallOfficials': [{'name': 'Thomas Fehr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cantonal Hospital Graubuenden'}, {'name': 'Patrick Hofmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cantonal Hospital Graubuenden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The local ethics committee approval does not include individual participant data sharing.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cantonal Hospital Graubuenden', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Zurich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Patrick Hofmann', 'investigatorAffiliation': 'Cantonal Hospital Graubuenden'}}}}