Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-01-04 @ 8:40 AM
Study NCT ID:
NCT00264368
Status:
TERMINATED
Last Update Posted:
2007-06-28
First Post:
2005-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D003586', 'term': 'Cytomegalovirus Infections'}, {'id': 'D009102', 'term': 'Multiple Organ Failure'}], 'ancestors': [{'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': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015774', 'term': 'Ganciclovir'}], 'ancestors': [{'id': 'D000212', 'term': 'Acyclovir'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-06-27', 'studyFirstSubmitDate': '2005-12-09', 'studyFirstSubmitQcDate': '2005-12-09', 'lastUpdatePostDateStruct': {'date': '2007-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparing the total clearance with the RRT derived clearance of GCV'}, {'measure': 'comparing the volume of distribution with historic controls of non Intensive Care Unit (ICU) patients'}], 'secondaryOutcomes': [{'measure': 'comparing GCV plasma concentration and population model derived estimates of these concentrations when including different relevant clinical co-factors such as: weight, S-creatinine, CL-creatinine, hydration, albumin, rest function of native kidneys etc.'}, {'measure': 'determine RRT derived GCV clearance during the different filtration/dialysis settings of the RRT machine'}]}, 'conditionsModule': {'keywords': ['Renal replacement therapy', 'CMV disease'], 'conditions': ['Acute Renal Failure', 'Cytomegalovirus Infections', 'Multi Organ Failure']}, 'descriptionModule': {'briefSummary': 'In order to optimize anti-cytomegalovirus (CMV) treatment with ganciclovir (GCV), in patients with multi organ failure treated with continuous renal replacement therapy (RRT), more information about ganciclovir pharmacokinetics in this setting is needed.\n\nThe primary objective is to describe the pharmacokinetics of ganciclovir in critically ill patients with acute renal failure treated with continuous renal replacement therapy, with a special emphasis on the extra-renal clearance and distribution volume.\n\nSecondary objectives are to investigate if any co-factors, such as serum creatinine, weight, general hydration status, rest function of the native kidneys, etc. can help to describe the pharmacokinetics of GCV in these patients on continuous RRT as well as the relative influence of filtrations and dialysis on GCV elimination during different modalities of the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in need of continuous RRT and GCV treatment\n* 18 years of age or older.\n\nExclusion Criteria:\n\n* Concomitant treatment with acyclovir or valacyclovir.\n* Patient does not give informed consent.'}, 'identificationModule': {'nctId': 'NCT00264368', 'briefTitle': 'Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Oslo School of Pharmacy'}, 'officialTitle': 'Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy', 'orgStudyIdInfo': {'id': 'GCV-PRISMA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'intravenous (IV) ganciclovir', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '0027', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Rikshospitalet, Section of Nephrology', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Anders Åsberg, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Oslo School of Pharmacy'}, {'name': 'Anders Hartmann, MD, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rikshospitalet, Medical Department'}, {'name': 'Jan F Bugge, MD, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Rikshospitalet, Department of Anaesthesiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oslo School of Pharmacy', 'class': 'OTHER'}}}}