Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-25 @ 4:32 PM
Study NCT ID:
NCT03596957
Status:
UNKNOWN
Last Update Posted:
2018-11-26
First Post:
2018-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With 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': 'D000077602', 'term': 'Tolvaptan'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The endpoint blinding will be assured since all the MRI scans will be forwarded to the Comparative Medicine Laboratory in Aarhus for evaluation'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomised in a 1:1 ration either to treatment with tolvaptan for six weeks followed by six weeks observation without trial medicaion or to the Control group receiving no tolvaptan treatment for 12 weeks'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-22', 'studyFirstSubmitDate': '2018-02-14', 'studyFirstSubmitQcDate': '2018-07-13', 'lastUpdatePostDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in total Kidney Volume (tKV) measured by MRI scanning', 'timeFrame': 'Between baseline and six weeks and between six and 12 weeks', 'description': 'The change in the total Kidney Volume after six and 12 weeks participation in the trial'}], 'secondaryOutcomes': [{'measure': 'Changes in GFR', 'timeFrame': 'Between baseline and six weeks and between baseline and 12 weeks', 'description': 'The changes in GFR measured by Cr-EDTA clearance'}, {'measure': 'Changes in relevant genetic and non-genetic biomarkers associated with CKD and ESRD', 'timeFrame': 'Between baseline and six weeks and between baseline and 12 weeks', 'description': 'Prediction of change in progression of the disease over time in the genes PKD1, PKD2, PKHD1 and HNF1B. The following biomarkers will be determined: NGAL, UMOD, MCP-1, KIM-1, cystatin-C and copeptin'}, {'measure': 'Changes in Quality of Life', 'timeFrame': 'Between baseline and six weeks and between baseline and 12 weeks', 'description': "Questionnaire SF36 Health Survey - with 36 questions to subject's health and wellbeing"}, {'measure': 'Subject estimation of own health', 'timeFrame': 'Between baseline and six weeks and between baseline and 12 weeks', 'description': 'Estimated by a Visual Analogue Scale from 0 (worth wellbeing) to 100 (best wellbeing'}, {'measure': 'Changes in ASAT and ALAT', 'timeFrame': 'Between baseline and six weeks and between baseline and 12 weeks', 'description': 'Changes estimated from laboratory results'}, {'measure': 'Incidence of Adverse Events', 'timeFrame': 'Between baseline and six weeks and between baseline and 12 weeks', 'description': 'Evaluation of Adverse Events including severity, causality, outcome and seriousness assessments'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autosomal Dominant Polycystic Kidney']}, 'descriptionModule': {'briefSummary': 'Investigator initiated controlled multi-centre trial in a Prospective, Randomised, Open, Blinded Endpoint (PROBE) design.\n\nPatients will be randomised in a 1:1 ratio either to treatment with tolvaptan for six weeks followed by six weeks observation without trial medication or no tolvaptan treatment, but following the same visit and investigation plan as the subjects taking tolvaptan.', 'detailedDescription': 'Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common genetic kidney disease and the fourth leading cause of end-stage renal disease in adults Worldwide.\n\nThe tolvaptan tablet has been approved by EMA (European Medicines Agency) with the indication of slowing the progression of cysts development and renal insufficiency in adults with ADPKD. It is the newest and only possible treatment for this patient group and could be initiated in patients with evidence for rapidly progressive disease Development.\n\nThere is however in Denmark and other countries both scientific and financial reluctance to initiate this expensive treatment for several reasons e.g. selection of patients who might benefit, effect on progression of kidney disease, side effects and tolerability.\n\nBefore deciding on implementation in Denmark, more knowledge is needed. The results of the PoCKET trial will contribute with guidance on this decision.\n\nForemost the trial is designed to address not only the change in kidney volume, but the change in kidney function, which is what matters to the patients and their prognosis in terms of postponing time to end stage renal disease. Furthermore, important data on side effects and tolerability will be generated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients between 18 and 65 years\n* Diagnosis of typical ADPKD\n* tKV above or equal to 750 ml by MRI scanning\n* Estimated GFR (e-GFR) by CKD-EPI formula of above or equal to 45 mL/min/1.73 m2\n\nExclusion Criteria:\n\n* Kidney transplant recipient\n* Known liver disease except for liver cysts relating to ADPKD\n* ASAT and ALAT above upper normal level\n* Current treatment with thiazide and thiazide-line diuretics, mineral corticoid receptor antagonists, amiloride or loop diuretics\n* Evidence of urinary tract obstruction\n* Current treatment with CYP3A4 inhibitors\n* Active malignant disease\n* Current or previous treatment with tolvaptan'}, 'identificationModule': {'nctId': 'NCT03596957', 'acronym': 'PoCKET', 'briefTitle': 'Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Nordsjaellands Hospital'}, 'officialTitle': 'Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney Disease', 'orgStudyIdInfo': {'id': 'PoCKET'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tolvaptan group', 'description': 'Treatment with tolvaptan for six weeks followed by six weeks observation without trial medication', 'interventionNames': ['Drug: Tolvaptan']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No tolvaptan treatment but following the same visit and investigation plan as the subjects in the tolvaptan group'}], 'interventions': [{'name': 'Tolvaptan', 'type': 'DRUG', 'otherNames': ['Jinarc'], 'description': 'At baseline the tolvaptan dosing will start with daily morning and afternoon doses of 45 mg and 15 mg respectively, with weekly increases to 60 mg and 30 mg and then to 90 mg and 30 mg according to subject tolerability', 'armGroupLabels': ['Tolvaptan group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Skejby', 'state': 'Aarhus N', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Henrik Birn, MD', 'role': 'CONTACT', 'email': 'hb@biomed.au.dk', 'phone': '+45 6171 7870'}, {'name': 'Karin Hansen', 'role': 'CONTACT', 'email': 'Karin.hansen@skejby.rm.dk', 'phone': '+45 4046 0831'}], 'facility': 'Aarhus University Hospital - Site 43', 'geoPoint': {'lat': 56.19966, 'lon': 10.17587}}, {'zip': '5000', 'city': 'Odense', 'state': 'Odense C', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Helle Thiesson, MD', 'role': 'CONTACT', 'email': 'helle.thiesson@rsyd.dk', 'phone': '+45 6541 1642'}, {'name': 'Kristian Bergholt Buhl, MD', 'role': 'CONTACT', 'email': 'kristian.bergholt.buhl@rsyd.dk', 'phone': '+456541 1642'}], 'facility': 'Odense University Hospital - Site 45', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '2100', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Bo Feldt-Rasmussen, MD', 'role': 'CONTACT', 'email': 'Bo.Feldt-Rasmussen@regionh.dk', 'phone': '+45 3545 2135'}, {'name': 'Tobias Bomholt, MD', 'role': 'CONTACT', 'email': 'tobias.bomholt@regionh.dk', 'phone': '+45 35451838'}], 'facility': 'Rigshospitalet - Site 42', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '2730', 'city': 'Herlev', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Ditte Hansen, MD', 'role': 'CONTACT', 'email': 'ditte.hansen@regionh.dk', 'phone': '+45 3868 2056'}, {'name': 'Marie Moeller, MD', 'role': 'CONTACT', 'email': 'marie.moeller@regioh.dk', 'phone': '+45 6169 5364'}], 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': '3400', 'city': 'Hillerød', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Lisbet Brandi, MD', 'role': 'CONTACT', 'email': 'lisbet.brandi@regionh.dk', 'phone': '+45 48295993'}, {'name': 'Charlotte Bjernved Nielsen', 'role': 'CONTACT', 'email': 'charlotte.bjernved.nielsen@regionh.dk', 'phone': '+45 49294714'}], 'facility': 'Nordsjaellands Hospital - Site 41', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}, {'zip': '4000', 'city': 'Roskilde', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Bjarne Ørskov, MD', 'role': 'CONTACT', 'email': 'bjaoe@regionsjalelland.dk', 'phone': '+45 2966 2426'}], 'facility': 'Sjællands University Hospital Roskilde', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}], 'centralContacts': [{'name': 'Lisbet Brandi, MD DMSc MHM', 'role': 'CONTACT', 'email': 'lisbet.brandi@regionh.dk', 'phone': '+45 48295993'}, {'name': 'Clinical Project Manager', 'role': 'CONTACT', 'email': 'charlotte.bjernved.nielsen@regionh.dk', 'phone': '+45 48294714'}], 'overallOfficials': [{'name': 'Lisbet Brandi, MD DMSc MHM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KNEA, Nordsjaellands Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lisbet Brandi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Department for Endrocrinology and Nephrology, MD, DMSc, MHM', 'investigatorFullName': 'Lisbet Brandi', 'investigatorAffiliation': 'Nordsjaellands Hospital'}}}}