Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT04799067
Status:
COMPLETED
Last Update Posted:
2023-07-06
First Post:
2021-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hyperkalaemia Prevalence, Recurrence and Treatment in Haemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006947', 'term': 'Hyperkalemia'}, {'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-05', 'studyFirstSubmitDate': '2021-02-24', 'studyFirstSubmitQcDate': '2021-03-11', 'lastUpdatePostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients experiencing any HK at the study enrolment or during a 24-week follow-up', 'timeFrame': 'up to 24 weeks', 'description': 'Proportion of patients experiencing any HK (defined as serum potassium \\> 5.0 mmol/L) at the study enrolment or during a 24-week follow-up'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients experiencing HK recurrence within 1, 2, 3, 4, 5 or 6 months (if applicable) during a 24-week follow-up including enrolment assessment', 'timeFrame': 'up to 24 weeks', 'description': 'Proportion of patients experiencing HK recurrence (defined as any HK event after the first HK event) within 1, 2, 3, 4, 5 or 6 months (if applicable) during a 24-week follow-up including enrolment assessment. A HK event is defined as any serum K+\\> 5.0 mmol/L within an interdialytic interval, which is usually two to three days.'}, {'measure': 'Proportion of patients with 2, 3, 4, 5, 6 or more than 6 events of HK during a 24-week follow-up including enrolment assessment', 'timeFrame': 'up to 24 weeks', 'description': 'Proportion of patients with 2, 3, 4, 5, 6 or more than 6 events of HK during a 24-week follow-up including enrolment assessment'}, {'measure': 'Intradialytic potassium shift at LIDI during the first week after patient enrolment', 'timeFrame': 'up to 1 week', 'description': 'Intradialytic potassium shift (defined as the difference between pre- and post-dialysis K+)at LIDI during the first week after patient enrolment'}, {'measure': 'Serum K+ at LIDI and SIDI in patients receiving HD thrice a week during the first week after patient enrolment', 'timeFrame': 'up to 1 week', 'description': 'Serum K+ at LIDI and SIDI in patients receiving HD thrice a week during the first week after patient enrolment'}, {'measure': 'Proportion of HK patients treated with any potassium binders and specific proportion of each potassium binder respectively during the 24-week follow up period', 'timeFrame': 'up to 24 weeks', 'description': 'Proportion of HK patients treated with any potassium binders including sodium polystyrene sulfonate ( calcium polystyrene sulfonate (CPS) or sodium zirconium cyclosilicate (SZC), and specific proportion of each potassium binder respectively during the 24-week follow up period'}, {'measure': 'Proportion of HK events treated with any potassium binders including SPS, CPS or SZC among total number of HK events during the 24-week follow up period', 'timeFrame': 'up to 24 weeks', 'description': 'Proportion of HK events treated with any potassium binders among total number of HK events during the 24-week follow up period'}, {'measure': 'Mean daily dose of SPS, CPS or SZC in patients treated with any potassium binder', 'timeFrame': 'up to 24 weeks', 'description': 'Mean daily dose of SPS, CPS or SZC in patients treated with any potassium binder'}, {'measure': 'Duration of the treatment of SPS, CPS or SZC in patients treated with any potassium binders', 'timeFrame': 'up to 24 weeks', 'description': 'Duration of the treatment of SPS, CPS or SZC in patients treated with any potassium binders'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hyperkalemia'], 'conditions': ['Hyperkalemia', 'Hemodialysis', 'Water-Electrolyte Imbalance']}, 'referencesModule': {'references': [{'pmid': '39252179', 'type': 'DERIVED', 'citation': 'Jin H, Lu R, Zhang L, Yao L, Shao G, Zuo L, Qin S, Zhang X, Zhang Q, Yu W, Luo Q, Ren Y, Peng H, Xiao J, Yang Q, Chen Q, Shi Y, Ni Z. Hyperkalemia burden and treatment patterns in Chinese patients on hemodialysis: final analysis of a prospective multicenter cohort study (PRECEDE-K). Ren Fail. 2024 Dec;46(2):2384585. doi: 10.1080/0886022X.2024.2384585. Epub 2024 Sep 9.'}, {'pmid': '37559023', 'type': 'DERIVED', 'citation': 'Ni Z, Jin H, Lu R, Zhang L, Yao L, Shao G, Zuo L, Qin S, Zhang X, Zhang Q, Yu W, Luo Q, Ren Y, Peng H, Xiao J, Yang Q, Chen Q, Shi Y; PRECEDE-K study group. Hyperkalaemia prevalence and dialysis patterns in Chinese patients on haemodialysis: an interim analysis of a prospective cohort study (PRECEDE-K). BMC Nephrol. 2023 Aug 9;24(1):233. doi: 10.1186/s12882-023-03261-8.'}, {'pmid': '34937724', 'type': 'DERIVED', 'citation': 'Ni Z, Jin H, Lu R, Zuo L, Yu W, Ren Y, Yang Q, Xiao J, Zhang Q, Zhang L, Zhang X, Chen Q, Chen C, Shao G, Luo Q, Yao L, Qin S, Peng H, Zhao Q; PRECEDE-K Study group. Hyperkalaemia prevalence, recurrence and treatment in patients on haemodialysis in China: protocol for a prospective multicentre cohort study (PRECEDE-K). BMJ Open. 2021 Dec 22;11(12):e055770. doi: 10.1136/bmjopen-2021-055770.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9480R00033&attachmentIdentifier=68e349a6-0176-4b00-b137-4af8956d8d35&fileName=D9480R00033_redacted_CSR_Synopsis.pdf&versionIdentifier=', 'label': 'redacted CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the prevalence and recurrence of Hyperkalaemia (HK) in Chinese HD patients and to understand the treatment pattern of HK in China.', 'detailedDescription': 'This is a prospective, cohort study. This study will include approximate 600 End Stage Renal Disease (ESRD) patients receiving Haemodialysis (HD) treatment twice a week or thrice a week.\n\nThe assessments at enrolment and in follow-up are summarized as follow:\n\nEnrolment - Patients will be in Long Interdialytic interval (LIDI) at enrolment (V1). Demographic characteristics, medical history, etiology of ESRD, concomitant medications, dialysis vintage, an electrocardiogram (ECG), a pre-dialysis serum potassium measurement and a post- dialysis serum potassium measurement, blood routine, blood gas analysis and other blood biochemistry measurements, etc., will be obtained.\n\nFollow-up - Potassium measurements, including pre-dialysis potassium measurements at LIDI once every month (V3-V8), pre-dialysis potassium at SIDI during the first week (V2) for patients in HD thrice a week specifically, will be obtained. Concomitant medications, blood routine, blood gas analysis and other blood biochemistry measurements, etc., will be obtained'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ESRD patients receiving HD treatment twice a week or thrice a week.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient aged ≥ 18 years at the time of signing the informed consent.\n2. Patients with ESRD and on haemodialysis (HD)\n3. The HD treatment frequency is ≥2 sessions per week\n4. Capable of giving signed informed consent\n\nExclusion Criteria:\n\n1. Acute kidney injury\n2. Expected to receive renal transplantation within 6 months\n3. Intracranial haemorrhage or elevated intracranial pressure within one month before enrolment\n4. Shock that cannot be corrected by drugs within one month before enrolment\n5. Failure to establish vascular access\n6. Has been receiving peritoneal dialysis\n7. Not suitable for this study judged by investigators'}, 'identificationModule': {'nctId': 'NCT04799067', 'acronym': 'PRECEDE-K', 'briefTitle': 'Hyperkalaemia Prevalence, Recurrence and Treatment in Haemodialysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Hyperkalaemia Prevalence, Recurrence and Treatment in Haemodialysis: A Prospective Multi-centre Cohort Study', 'orgStudyIdInfo': {'id': 'D9480R00033'}, 'secondaryIdInfos': [{'id': 'No secondary ID yet', 'type': 'OTHER', 'domain': 'No secondary ID yet'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'observational study', 'type': 'OTHER', 'description': 'no study drug involved, observational study.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Taihe', 'state': 'Hubei', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.86832, 'lon': 112.9882}}, {'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '2000127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'city': 'Yangquan', 'state': 'Shanxi', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 37.8575, 'lon': 113.56333}}, {'city': 'Ningbo', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}, {'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}