Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-27 @ 11:14 PM
Study NCT ID:
NCT00375635
Status:
UNKNOWN
Last Update Posted:
2006-09-13
First Post:
2006-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Removal of Protein Bound Uremic Toxins by Modified Plasma Separation and Adsorption Combined With Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014511', 'term': 'Uremia'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2006-10'}, 'lastUpdateSubmitDate': '2006-09-12', 'studyFirstSubmitDate': '2006-09-12', 'studyFirstSubmitQcDate': '2006-09-12', 'lastUpdatePostDateStruct': {'date': '2006-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure'}, {'measure': 'Safety serological parameters'}, {'measure': 'Concentrations of protein bound uremic toxins'}], 'secondaryOutcomes': [{'measure': 'Bleeding episodes'}]}, 'conditionsModule': {'keywords': ['mFPSA', 'Uremic toxins', 'Protein bound toxins', 'Uremia', 'Chronic hemodialysis'], 'conditions': ['Uremia']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine removal of protein bound uremic substances by mFPSA in chronic hemodialysis patients. mFPSA is an extracorporal blood purification system developed for detoxification in acute liver failure by removal of protein bound as well as water soluble substances.', 'detailedDescription': 'Measurements of uremic protein bound substances before and after mFPSA and a preceding routine hemodialysis session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over the age of 18\n* Anuria\n* Chronic hemodialysis dependence\n\nExclusion Criteria:\n\n* No present history of bleeding episodes\n* Cardiac diseases'}, 'identificationModule': {'nctId': 'NCT00375635', 'briefTitle': 'Removal of Protein Bound Uremic Toxins by Modified Plasma Separation and Adsorption Combined With Hemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Removal of Protein Bound Uremic Toxins in Chronic Hemodialysis Patients by Modified Plasma Separation and Adsorption Combined With Hemodialysis', 'orgStudyIdInfo': {'id': 'MBD2006'}}, 'armsInterventionsModule': {'interventions': [{'name': 'mFPSA treatment', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2200', 'city': 'Copenhagen', 'state': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Mette B Damholt, MD,Ph.d.', 'role': 'CONTACT', 'email': 'damholt@dadlnet.dk', 'phone': '+45 35450589'}, {'name': 'Mette B Damholt, MD,Ph.d.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Mette B Damholt, MD,Ph.d.', 'role': 'CONTACT', 'email': 'damholt@dadlnet.dk', 'phone': '+45 35453545', 'phoneExt': '50589'}, {'name': 'Soren D Ladefoged, MD', 'role': 'CONTACT', 'email': 'SOERENRH04736LADEFOGED@rh.dk', 'phone': '+45 35453545', 'phoneExt': '51020'}], 'overallOfficials': [{'name': 'Mette B Damholt, MD,Ph.d.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet P2132'}, {'name': 'Soren D Ladefoged, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}}}}