Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-31 @ 1:21 PM
Study NCT ID:
NCT01111266
Status:
COMPLETED
Last Update Posted:
2012-03-14
First Post:
2010-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determination of in Vivo Ultrafiltration Coefficient (KUF) in Patients With Chronic Kidney Disease (CKD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-13', 'studyFirstSubmitDate': '2010-04-15', 'studyFirstSubmitQcDate': '2010-04-26', 'lastUpdatePostDateStruct': {'date': '2012-03-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'in vivo KUF', 'timeFrame': '6 weeks', 'description': 'The objective of this study is to to determine in vivo KUF for three different sizes (1.2; 1.8 and 2.3 m\\^2) of xevonta High-Flux to compare obtained data with respective in vitro KUF data.'}], 'secondaryOutcomes': [{'measure': 'Determination of removal rates', 'timeFrame': '6 weeks', 'description': 'Removal rates for urea, phosphate, creatinine, albumin, leptin and Beta2-microglobulin will be determined.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['in vivo KUF', 'ß2M', 'leptin'], 'conditions': ['Kidney Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the in-vivo ultrafiltration coefficient for different sizes of xevonta High-Flux dialyzers following FDA guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent obtained from patient or parents/ guardian.\n* Subject age \\>= 18\n* Effective blood flow 350 ml/min and dialysate flow of 500 ml/min\n* On hemodialysis for a minimum of 3 months\n* Use of Cimino- or Gore-tex shunts\n* Routine dialysis-treatment for 240 min\n* Documented dialysis adequacy parameter that has been stable for past 3 months\n* Plan to dialyze at participating hemodialysis centre for at least 3-months duration.\n* Free from any currently known unusual clotting or access problems\n* Hepatitis B surface antigen (HbsAg) negative, documented within the past 90 days or Hepatitis B surface antibody (anti-HBs) positive.\n* Anti Hepatitis C Virus (Anti-HCV) negative, documented within the past 90 days\n* Anti Human Immunodeficiency Virus (Anti HIV) negative, documented within the past 90 days\n* Hematocrit (HCT) between 25 and 40% or haemoglobin (Hb) not less than 8 g/dL, as documented 14 days prior to the first treatment\n\nExclusion Criteria:\n\n* Patients who are unable to tolerate an effective blood flow of 350 ml/min\n* Patients using catheter for dialysis\n* Pregnant or nursing woman. Women of childbearing potential must agree to avoid pregnancy during the study period by use of hormonal contraception (implantable; patch; oral) and/ or double-barrier methods (any double combination of: IUD; condom with spermicidal gel; diaphragm; sponge; cervical cap)\n* Previous plan for extended absences from the participating hemodialysis centre\n* Expected to be transplanted (living related donor) within the maximum of 3 months for the study period\n* Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of the study'}, 'identificationModule': {'nctId': 'NCT01111266', 'briefTitle': 'Determination of in Vivo Ultrafiltration Coefficient (KUF) in Patients With Chronic Kidney Disease (CKD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'B.Braun Avitum AG'}, 'officialTitle': 'Evaluation of Performance and Safety Profile of Xevonta High Flux Dialyzer With Special Focus on Determination of in Vivo Ultrafiltration Coefficient in Patients With CKD', 'orgStudyIdInfo': {'id': 'BA-I-H-09-02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'xevonta', 'type': 'DEVICE', 'description': 'Patients will be treated with 3 different sizes of xevonta (2 weeks each size) for determination of in vivo KUF following "FDA Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers". In addition blood samples will be collected for determination of removal rates of different small molecules and protein.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35392', 'city': 'Giessen', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Georg-Haas Dialysezentrum der PHV', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}], 'overallOfficials': [{'name': 'Jürgen Wagner, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'B.Braun Avitum AG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'B.Braun Avitum AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Labor Limbach, Heidelberg, Germany', 'class': 'UNKNOWN'}, {'name': 'Clin-Sol, Würzburg, Germany', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}