Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-02-28 @ 9:04 PM
Study NCT ID:
NCT02092194
Status:
UNKNOWN
Last Update Posted:
2014-03-20
First Post:
2014-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Versus Standard Volume Hemodiafiltration in Asia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-19', 'studyFirstSubmitDate': '2014-03-17', 'studyFirstSubmitQcDate': '2014-03-19', 'lastUpdatePostDateStruct': {'date': '2014-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in the serum concentration of β2 microglobulin', 'timeFrame': 'between baseline and 24 weeks after treatment'}], 'secondaryOutcomes': [{'measure': 'Dialysis Adequacy', 'timeFrame': '24 weeks', 'description': 'Kt/V by the single pool variable volume formula.'}, {'measure': 'Inflammatory markers', 'timeFrame': '24 weeks', 'description': 'C-reactive protein (CRP), interleukin-6, tumor necrosis factor-α.'}, {'measure': 'Nutritional status', 'timeFrame': '24 weeks', 'description': 'normalized protein nitrogen appearance rate, serum albumin, serum protein, subjective global assessment (SGA)'}, {'measure': 'Intradialytic hypotension', 'timeFrame': '24 weeks', 'description': 'Number of episode of symptomatic hypotension'}, {'measure': 'Quality of Life', 'timeFrame': 'baseline and 24 weeks after treatment', 'description': 'SF-36-K (Korean version)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['beta 2-Microglobulin', 'Hemodiafiltration', 'convective volume'], 'conditions': ['End-stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'Online hemodiafiltration (HDF) may improve clinical outcome in end-stage renal disease. The supported mechanism is the improved clearance of uremic toxins by convective transporter. However, It has not been elucidated which convection volume is optimal, especially in Asia. A total of 60 participants receiving conventional hemodialysis will be randomly assigned to receive either high dose convective volume (33-43 L/treatment) post-dilution online HDF or standard dose (16.8-21.5 L/treatment) for 24 weeks. The primary outcome is the change of serum β2 microglobulin levels between baseline and after 24 weeks. The secondary outcomes will include changes in the nutritional markers, inflammatory markers, and blood pressure from baseline to after treatment.\n\nThis would be the first multicenter prospective, randomized controlled trial to determine whether large convective volume improves the treatment efficacy in Korean patients undergoing post-dilution online HDF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients on thrice-weekly standard hemodialysis for \\> 3 months\n* Patients with a vascular access capable of delivering consistently a high blood flow rates ( ≥ 300 mL/min)\n* Patients willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Patients with active infectious or uncontrolled inflammatory disorders\n* Patients with any uncontrolled malignant disease\n* Patients with recent major cardiovascular disease during the last 6 months\n* Patients who are likely to receive kidney transplant within the following 1 year\n* Patients whose life expectancy \\< 12 months\n* Patients considered by investigator to have difficulty in participation'}, 'identificationModule': {'nctId': 'NCT02092194', 'briefTitle': 'High Versus Standard Volume Hemodiafiltration in Asia', 'organization': {'class': 'OTHER', 'fullName': 'Korean Hemodialysis Study Group'}, 'officialTitle': 'Effectiveness of High-volume Online Hemodiafiltration Compared to Standard Volume Online Hemodiafiltration. A Prospective, Multicenter, Randomized, Open-labelled Interventional Study.', 'orgStudyIdInfo': {'id': 'KHSG-201301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Dose online HDF', 'description': 'Proposed target convection volume; 16.8-21.5 L/treatment (70-90 mL/min)', 'interventionNames': ['Procedure: Standard Dose Online HDF']}, {'type': 'EXPERIMENTAL', 'label': 'High Dose online HDF', 'description': 'Proposed target convection volume; 33-43 L/treatment (140-180 mL/min).', 'interventionNames': ['Procedure: High Dose Online HDF']}], 'interventions': [{'name': 'High Dose Online HDF', 'type': 'PROCEDURE', 'otherNames': ['High Volume online hemodiafiltration'], 'description': 'Convection volume; 33-43 L/treatment (140-180 mL/min)', 'armGroupLabels': ['High Dose online HDF']}, {'name': 'Standard Dose Online HDF', 'type': 'PROCEDURE', 'otherNames': ['Standard Volume online hemodiafiltration'], 'description': 'convection volume; 16.8-21.5 L/treatment (70-90 mL/min)', 'armGroupLabels': ['Standard Dose online HDF']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'contacts': [{'name': 'Sung Gyun Kim, MD', 'role': 'CONTACT', 'email': 'imnksk@gmail.com', 'phone': '+82-31-380-3976'}, {'name': 'Soo Jin Kim, MD', 'role': 'CONTACT', 'email': 'dongangagy@lycos.co.kr', 'phone': '+82-10-8722-8078'}, {'name': 'Sung Gyun Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Soo Jin Kim, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hallym University Sacred Heart Hospital', 'geoPoint': {'lat': 37.3925, 'lon': 126.92694}}, {'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Su-Hyun Kim, MD', 'role': 'CONTACT', 'email': 'sh76so@cau.ac.kr'}, {'name': 'Su-Hyun Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chung-Ang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Won-Yong Cho, MD', 'role': 'CONTACT', 'email': 'wonyong@korea.ac.kr'}, {'name': 'Won-Yong Cho, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Kwon Wook Joo, MD', 'role': 'CONTACT', 'email': 'junephro@snu.ac.kr'}, {'name': 'Kwon Wook Joo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Sun Ryoung Choi, MD', 'role': 'CONTACT', 'email': 'ryounge@hanmail.net'}, {'name': 'Sun-Ryoung Choi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shamyook Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Hyeong Cheon Park, MD', 'role': 'CONTACT', 'email': 'amp97@yuhs.ac'}, {'name': 'Hyeong Cheon Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yonsei University Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Sung Gyun Kim, MD', 'role': 'CONTACT', 'email': 'imnksk@gmail.com', 'phone': '+82-10-3586-8561'}, {'name': 'Soo Jin Kim, MD', 'role': 'CONTACT', 'email': 'dongangagy@lycos.co.kr', 'phone': '+82-10-8722-8078'}], 'overallOfficials': [{'name': 'Won-Yong Cho, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Korea University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korean Hemodialysis Study Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boryung Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sung Gyun Kim', 'investigatorAffiliation': 'Korean Hemodialysis Study Group'}}}}