Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-01-05 @ 6:06 PM
Study NCT ID:
NCT06390592
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-17
First Post:
2024-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Performance of the Therapy Option FlexPoint of the PD Cycler Sleep•Safe Harmony
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Interventional, prospective, multi-centric, controlled, randomized, crossover'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2024-04-25', 'studyFirstSubmitQcDate': '2024-04-25', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Kt/V urea', 'timeFrame': 'every 2 weeks, during the 6 weeks treatment', 'description': 'Measurement of solute removal during peritoneal dialysis focuses on urea'}], 'secondaryOutcomes': [{'measure': 'Mean daily ultrafiltration (UF)', 'timeFrame': 'every day, during the 6 weeks treatment', 'description': 'Daily ultrafiltration reached by the patient during peritoneal dialysis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Renal replacement therapy', 'Peritoneal dialysis', 'Automated peritoneal dialysis', 'PD cycler'], 'conditions': ['Renal Failure', 'Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'Analysis and comparison of treatments with and without the FlexPoint technology (flexible volume and dwell time management) of the PD cycler sleep•safe harmony', 'detailedDescription': 'The primary objective of this study are:\n\n* to investigate and compare the clinical performance of standard (default) FlexPoint settings to minimum FlexPoint settings and to the maximum value for permitted peritoneal residual volume of FlexPoint settings of the PD cycler sleep•safe harmony in the treatment of PD patients.\n* to assess whether usage of the settings of the therapy option FlexPoint (flexible volume and dwell time management) of the PD cycler sleep•safe harmony that deviate from the system default and from former sleep•safe settings, influences the efficacy of APD treatments as well as the hydration status (by using BCM) of PD patients.\n\nThe secondary objectives of this study are:\n\n* Patients´ Quality of Life (QoL)\n* Number of alarms\n* To investigate the effects on solute removal\n* To investigate the tolerability of the FlexPoint therapy options\n* Adverse events / SAE'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Informed consent signed and dated by study patient and investigator/ authorised physician\n* Minimum age of 18 years\n* CKD patients with indication for renal replacement therapy\n* Patients being treated with APD for at least 3 months\n* Patients using the sleep•safe harmony PD cycler (version 3.1)\n* Fluid status regularly monitored with Body Composition Monitor (BCM)\n* Proper functioning catheter\n* Intraperitoneal Pressure (IPP) ≤ 18 cm H2O\n* Ability to understand the nature and requirements of the study\n\nExclusion Criteria:\n\n* Any conditions which could interference with the patient's ability to comply with the study\n* Previous participation in the same study\n* Patients who have any condition prohibiting the use of BCM, like patients with major amputations (e.g. lower leg)\n* Patients receiving polyglucose containing PD solution\n* Respiratory or abdominal wall disease deemed to contraindicate intraperitoneal fill volume (FV) manipulation\n* Patients who suffer from peritonitis/exit site infection during the last 4 weeks\n* Women of childbearing age without effective means of contraception, pregnancy (pregnancy test will be conducted at start and end of study) or lactation period\n* Life expectancy \\<3 months\n* Participation in an interventional clinical study during the preceding 90 days"}, 'identificationModule': {'nctId': 'NCT06390592', 'acronym': 'FlexPoint', 'briefTitle': 'Clinical Performance of the Therapy Option FlexPoint of the PD Cycler Sleep•Safe Harmony', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Medical Care Deutschland GmbH'}, 'officialTitle': 'Clinical Performance of the Therapy Option FlexPoint (Flexible Volume and Dwell Time Management) of the PD Cycler Sleep•Safe Harmony', 'orgStudyIdInfo': {'id': 'PD-SSH-01-INT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Peritoneal dialysis (PD)', 'description': 'During the clinical phase, patients are treated continuously with the PD cycler sleep•safe harmony.\n\nThe total duration of the clinical phase is six weeks and is divided into 3 Phases à 2 weeks (Clinical phase I, II, and III) which only differ in the FlexPoint settings.\n\nAccording to their randomization the patients are treated with Treatment A, B or C in a different order:\n\n* standard (default) FlexPoint settings (Treatment A)\n* minimum value FlexPoint settings (Treatment B)\n* maximum value for permitted peritoneal residual volume (50%) of FlexPoint settings (Treatment C)', 'interventionNames': ['Device: PD cycler']}], 'interventions': [{'name': 'PD cycler', 'type': 'DEVICE', 'description': 'Patients are treated continuously during Peritoneal dialysis with the PD cycler sleep•safe harmony with different FlexPoint settings.\n\nAccording to their randomization the patients are treated with Treatment A, B or C in a different order:\n\n* standard (default) FlexPoint settings (Treatment A)\n* minimum value FlexPoint settings (Treatment B)\n* maximum value for permitted peritoneal residual volume (50%) of FlexPoint settings (Treatment C)', 'armGroupLabels': ['Peritoneal dialysis (PD)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Manuela Stauss-Grabo, Dr.', 'role': 'CONTACT', 'email': 'Manuela.Stauss-Grabo1@freseniusmedicalcare.com', 'phone': '+4961726085248'}, {'name': 'Tatiana De los Rios', 'role': 'CONTACT', 'email': 'tatiana.de-los-rios@freseniusmedicalcare.com', 'phone': '+4961722688876'}], 'overallOfficials': [{'name': 'Maite Rivera Gorrín, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Ramón y Cajal'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fresenius Medical Care Deutschland GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Alcedis GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}