Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-02-25 @ 11:48 PM
Study NCT ID:
NCT02522104
Status:
COMPLETED
Last Update Posted:
2021-10-12
First Post:
2015-08-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Impact of Renal Function on the Pharmacokinetics of SIKLOS ® (DARH)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006918', 'term': 'Hydroxyurea'}], 'ancestors': [{'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'corinne.duguet@addmedica.com', 'phone': '+33 1 72 69 01 86', 'title': 'Medical director', 'organization': 'Addmedica'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From the signature of the informed consent form by the patient until 7 days after the end of the follow-up for the study. 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'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaso-occlusive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Measure of Plasmatic Data: Maximum Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal-renal 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[{'value': '3.9', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '0.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From 0 to 4 hours, 4 to 7.5 hours and 7.5 to 24 hours', 'description': 'Compare the pharmacokinetic parameters of hydroxyurea in normal-renal function sickle cell patients to those of patients with glomerular hyperfiltration or moderate renal failure', 'unitOfMeasure': 'Liter/Hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Normal-renal Function', 'description': 'Patients with normal-renal function defined by 90 ≤ GFR ≤ 130 mL/min/1.73m2 in women or 140 mL/min/1.73m2 in men'}, {'id': 'FG001', 'title': 'Glomerular Hyperfiltration', 'description': 'Patients with glomerular renal hyperfiltration defined by GFR \\> 130 mL/min/1.73m2 in women and GFR \\> 140 mL/min/1.73m2 in men'}, {'id': 'FG002', 'title': 'Moderate Renal Failure', 'description': 'Patients with moderate renal failure defined by 30 ≤ GFR ≤ 60 mL/min/1.73m2'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Normal-renal Function', 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Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2016-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-20', 'studyFirstSubmitDate': '2015-08-04', 'resultsFirstSubmitDate': '2021-08-03', 'studyFirstSubmitQcDate': '2015-08-11', 'lastUpdatePostDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-03', 'studyFirstPostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure of Plasmatic Data: Maximum Concentration (Cmax)', 'timeFrame': '0 hour, 0.75 hour, 1.5 hours, 3 hours, 4 hours, 6 hours, 7.5 hours , 24 hours', 'description': 'Compare the pharmacokinetic parameters of hydroxyurea in normal-renal function sickle cell patients to those of patients with glomerular hyperfiltration or moderate renal failure'}, {'measure': 'Measure of Plasmatic Data: Minimum Concentration (Cmin)', 'timeFrame': '0 hour, 0.75 hour, 1.5 hours, 3 hours, 4 hours, 6 hours, 7.5 hours , 24 hours', 'description': 'Compare the pharmacokinetic parameters of hydroxyurea in normal-renal function sickle cell patients to those of patients with glomerular hyperfiltration or moderate renal failure'}, {'measure': 'Measure of Plasmatic Data: Time to Obtain the Maximum Concentration (Tmax)', 'timeFrame': '0 hour, 0.75 hour, 1.5 hours, 3 hours, 4 hours, 6 hours, 7.5 hours , 24 hours', 'description': 'Compare the pharmacokinetic parameters of hydroxyurea in normal-renal function sickle cell patients to those of patients with glomerular hyperfiltration or moderate renal failure'}, {'measure': 'Measure of Plasmatic Data: Area Under the Curve (AUC0-24)', 'timeFrame': '0 hour, 0.75 hour, 1.5 hours, 3 hours, 4 hours, 6 hours, 7.5 hours , 24 hours', 'description': 'Compare the pharmacokinetic parameters of hydroxyurea in normal-renal function sickle cell patients to those of patients with glomerular hyperfiltration or moderate renal failure'}, {'measure': 'Measure of Plasmatic Data: Elimination Half-life (T½)', 'timeFrame': '0 hour, 0.75 hour, 1.5 hours, 3 hours, 4 hours, 6 hours, 7.5 hours , 24 hours', 'description': 'Compare the pharmacokinetic parameters of hydroxyurea in normal-renal function sickle cell patients to those of patients with glomerular hyperfiltration or moderate renal failure'}, {'measure': 'Measure of Plasmatic Data: Total Clearance (Cl Tot)', 'timeFrame': '0 hour, 0.75 hour, 1.5 hours, 3 hours, 4 hours, 6 hours, 7.5 hours , 24 hours', 'description': 'Compare the pharmacokinetic parameters of hydroxyurea in normal-renal function sickle cell patients to those of patients with glomerular hyperfiltration or moderate renal failure'}, {'measure': 'Measure of Plasmatic Data: Distribution Volume', 'timeFrame': '0 hour, 0.75 hour, 1.5 hours, 3 hours, 4 hours, 6 hours, 7.5 hours , 24 hours', 'description': 'Compare the pharmacokinetic parameters of hydroxyurea in normal-renal function sickle cell patients to those of patients with glomerular hyperfiltration or moderate renal failure'}, {'measure': 'Measure of Urinary Data: Hydroxyurea Urinary Fractions', 'timeFrame': 'From 0 to 4 hours, 4 to 7.5 hours and 7.5 to 24 hours', 'description': 'Compare the pharmacokinetic parameters of hydroxyurea in normal-renal function sickle cell patients to those of patients with glomerular hyperfiltration or moderate renal failure'}, {'measure': 'Measure of Urinary Data: Renal Clearance (Cl Renal).', 'timeFrame': 'From 0 to 4 hours, 4 to 7.5 hours and 7.5 to 24 hours', 'description': 'Compare the pharmacokinetic parameters of hydroxyurea in normal-renal function sickle cell patients to those of patients with glomerular hyperfiltration or moderate renal failure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pharmacokinetics of Hydroxyurea'], 'conditions': ['Sickle Cell Disease', 'Renal Function Disorder']}, 'descriptionModule': {'briefSummary': 'The use of hydroxyurea in sickle cell disease patients with glomerular hyperfiltration and renal failure requires a specific monitoring and dose adjustment in order to remain within the therapeutic interval while limiting the risk of toxicity or therapeutic failure. For this reason the investigators propose to compare the pharmacokinetic parameters of hydroxyurea in normal-renal function sickle cell patients to those of patients with glomerular hyperfiltration or moderate renal failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Male or female.\n* Sickle cell disease (SS or S-β0thal) confirmed by haemoglobin electrophoresis and genotyping by deoxyribonucleic acid (DNA) analysis.\n* Affiliation to a social security system.\n* Having freely consented in writing after being informed of the objective, programme and potential risks incurred.\n\nThese criteria will apply to the 3 groups of sickle cell disease patients according to the renal function stage defined by the glomerular filtration rate (GFR) estimated by the formula of the Chronic Kidney Disease EPIdemiology (CKD EPI) collaboration without ethnic criterion during the last 6 months before inclusion:\n\n* Normal-renal function: 90 ≤ GFR ≤ 130 mL/min/1.73m2 in women or 140 mL/min/1.73m2 in men.\n* Moderate renal failure: 30 ≤ GFR ≤ 60 mL/min/1.73m2.\n* Glomerular renal hyperfiltration: GFR \\> 130 mL/min/1.73m2 in women and GFR \\> 140 mL/min/1.73m2 in men.\n\n * Treated with hydroxyurea (Siklos®) with a stable dosage for at least one week ± 2 days before inclusion in the study and dose administered in the morning at 9:00 ± 15 minutes.\n\nExclusion Criteria:\n\n* Refusal to consent.\n* Patients that do not comply.\n* Occurrence of vaso-occlusive crisis in the month prior to the inclusion in the study.\n* Patients having had an exchange transfusion in the 15 days before inclusion in the study.\n* Patients participating in another clinical trial or in the exclusion period of a previous clinical trial.\n* Patients treated with a diuretic.\n* Dialysis patient.\n* Patients with an intercurrent disorder, especially inflammatory, that has not recovered for at least one month.\n* Pregnant or breast-feeding women.\n* Patients deprived of liberty or under legal protection.\n* Patients who cannot understand the objective and the course of the study, incapable of giving their consent.\n* In the event of severe hepatic failure.\n* In the event of severe renal failure (creatinine clearance \\< 30 ml/min).\n* Patients who show toxic signs of bone marrow suppression.'}, 'identificationModule': {'nctId': 'NCT02522104', 'briefTitle': 'Evaluation of the Impact of Renal Function on the Pharmacokinetics of SIKLOS ® (DARH)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Theravia'}, 'officialTitle': 'Evaluation of the Impact of Renal Function on the Pharmacokinetics of Hydroxyurea (SIKLOS ®) in Normal-renal Function, Hyperfiltrating and Renal Failure Sickle Cell Disease Patients (DARH)', 'orgStudyIdInfo': {'id': 'SIK-FR 14-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Normal-renal function', 'description': 'Normal-renal function: 90 ≤ GFR ≤ 130 mL/min/1.73m2 in women or 140 mL/min/1.73m2 in men', 'interventionNames': ['Drug: Siklos']}, {'type': 'EXPERIMENTAL', 'label': 'Glomerular hyperfiltration', 'description': 'Glomerular renal hyperfiltration: GFR \\> 130 mL/min/1.73m2 in women and GFR \\> 140 mL/min/1.73m2 in men.', 'interventionNames': ['Drug: Siklos']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate renal failure', 'description': 'Moderate renal failure: 30 ≤ GFR ≤ 60 mL/min/1.73m2', 'interventionNames': ['Drug: Siklos']}], 'interventions': [{'name': 'Siklos', 'type': 'DRUG', 'otherNames': ['hydroxyurea'], 'armGroupLabels': ['Glomerular hyperfiltration', 'Moderate renal failure', 'Normal-renal function']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Créteil', 'country': 'France', 'facility': 'Centre de Référence des Syndromes Drépanocytaires Majeurs, Hôpital Henri-Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'overallOfficials': [{'name': 'BARTOLUCCI Pablo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre de Référence des Syndromes Drépanocytaires Majeurs, Hôpital Henri-Mondor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Theravia', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}