Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-26 @ 4:39 AM
Study NCT ID:
NCT01449266
Status:
COMPLETED
Last Update Posted:
2015-07-08
First Post:
2011-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Dialysability of Dotarem® in Dialysed Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C072417', 'term': 'gadoterate meglumine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pierre.desche@guerbet-group.com', 'phone': '+33 1 45 91 50 00', 'title': 'Dr. Pierre Desché, MD - VP Development, Medical and Regulatory Affairs', 'organization': 'Guerbet'}, 'certainAgreement': {'otherDetails': 'No unpublished data given to the investigator may be transmitted to a third party without approval by the sponsor. The data are the exclusive property of Guerbet.\n\nThe investigator undertakes to submit to Guerbet any articles or papers related to this study within 30 days of their submission to journals or congresses.\n\nAll publications must have the joint agreement of the investigator and the sponsor.\n\nThe investigator remains independent with no relationship of subordination with Guerbet.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Safety assessment was performed at the day 1, day 2, and day 4 after Dotarem® injection. Two safety follow-up visits were performed at 3 weeks (+/- 2 days) and at 3 months (+/- 4 days) after Dotarem® injection.', 'description': "Adverse events (AEs) were followed from the subject's screening to the first safety follow-up visit (3 weeks +/- 2 days after the Dotarem® injection). At the second safety follow-up visit (3 months +/- 4 days after the Dotarem® injection), only Serious Adverse Events (SAEs) were evaluated.", 'eventGroups': [{'id': 'EG000', 'title': 'Dotarem® Injected Patients', 'description': 'Male or female, aged ≥18 years\n\n• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)\n\nDotarem: Dotarem® was administered at a single dose of 0.1 mmoL/kg (0.2 mL/kg).', 'otherNumAtRisk': 10, 'otherNumAffected': 8, 'seriousNumAtRisk': 10, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Hypotension', 'notes': 'This adverse event was considered as not related to the Dotarem® injection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Headache', 'notes': 'This adverse event was considered as not related to the Dotarem® injection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Muscle spasms', 'notes': 'This adverse event was considered as not related to the Dotarem® injection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Anemia', 'notes': 'This adverse event was considered as not related to the Dotarem® injection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Abdominal pain', 'notes': 'This adverse event was considered as not related to the Dotarem® injection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'influenza-like illness', 'notes': 'This adverse event was considered as not related to the Dotarem® injection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'thirst', 'notes': 'This adverse event was considered as not related to the Dotarem® injection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Procedural pain', 'notes': 'This adverse event was considered as not related to the Dotarem® injection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Arthralgia', 'notes': 'This adverse event was considered as not related to the Dotarem® injection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Musculoskeletal pain', 'notes': 'This adverse event was considered as not related to the Dotarem® injection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Dizziness postural', 'notes': 'This adverse event was considered as not related to the Dotarem® injection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Presyncope', 'notes': 'This adverse event was considered as not related to the Dotarem® injection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hypertension', 'notes': 'This adverse event was considered as not related to the Dotarem® injection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}], 'seriousEvents': [{'term': 'moderate sepsis', 'notes': 'Five days after Dotarem® injection subject experienced moderate sepsis deemed not related. Subject was hospitalized and recovered after 15 days following antibiotic treatment.\n\nThis AE was considered as not related to the Dotarem® injection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'severe respiratory failure', 'notes': 'This adverse event was considered as not related to the Dotarem® injection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'severe peripheral ischemia', 'notes': 'This adverse event was considered as not related to the Dotarem® injection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'moderate thrombocytopenia', 'notes': 'This adverse event was considered as not related to the Dotarem® injection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'severe urosepsis', 'notes': 'This adverse event was considered as not related to the Dotarem® injection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Dialysis device insertion', 'notes': 'This adverse event was considered as not related to the Dotarem® injection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Nephrectomy', 'notes': 'This adverse event was considered as not related to the Dotarem® injection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dialysability of Dotarem® in Dialysed Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dotarem® Injected Patients', 'description': 'Male or female, aged ≥18 years\n\n• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)'}], 'classes': [{'title': 'Percent change at 0.5h after first hemodialysis', 'categories': [{'measurements': [{'value': '-88.2', 'groupId': 'OG000', 'lowerLimit': '-93.5', 'upperLimit': '-84.7'}]}]}, {'title': 'Percent change at 1.5h after first hemodialysis', 'categories': [{'measurements': [{'value': '-93.4', 'groupId': 'OG000', 'lowerLimit': '-95.7', 'upperLimit': '-90.3'}]}]}, {'title': 'Percent change at 4h after first hemodialysis', 'categories': [{'measurements': [{'value': '-97.1', 'groupId': 'OG000', 'lowerLimit': '-99.1', 'upperLimit': '-90.5'}]}]}, {'title': 'Percent change at 4h after second hemodialysis n=7', 'categories': [{'measurements': [{'value': '-94.8', 'groupId': 'OG000', 'lowerLimit': '-97.7', 'upperLimit': '-84.8'}]}]}, {'title': 'Percent change at 4h after third hemodialysis n=2', 'categories': [{'measurements': [{'value': '-89.9', 'groupId': 'OG000', 'lowerLimit': '-94.9', 'upperLimit': '-85.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Dotarem® dialysability assessed up to 4 days after Dotarem® administration', 'description': 'To evaluate the decrease in seric concentration of gadolinium, after each hemodialysis session of patients injected with 0.1 mmol/kg of Dotarem® . The percent change of gadolinium concentration is calculated by estimating the amount of serum gadolinium before and after each hemodialysis session. Calculations are performed only for subjects with concentration above the lower limit of quantification (LLQ)', 'unitOfMeasure': 'percent change in Gd concentration', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'After second hemodialysis, 3 subjects had Gd concentration\\<LLQ and are not included in the analysis; after third hemodialysis, 8 subjects had Gd concentration\\<LLQ and are not included in the analysis'}, {'type': 'SECONDARY', 'title': 'Safety of Dotarem® in Dialysed Patients Evaluated by the Number of Patients Experiencing Adverse Events.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dotarem® Injected Patients', 'description': 'Male or female, aged ≥18 years\n\n• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Safety assessed from patients inclusion until the last follow-up visit 3 months after Dotarem® administration', 'description': 'To evaluate the biological and clinical safety of Dotarem® by assessing vital signs, biological parameters, injection-site tolerance, through a 4-day post injection follow-up, adverse events through a 3-week post injection period and serious adverse events through a 3-month post injection period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Percent Change in Gadolinium Serum Concentration 4h After Second Hemodialysis Session, Estimated From Subjects With Concentration Data Above the Limit of Detection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dotarem® Injected Patients', 'description': 'Male or female, aged ≥18 years\n\n• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)'}], 'classes': [{'categories': [{'measurements': [{'value': '-99.5', 'groupId': 'OG000', 'lowerLimit': '-99.8', 'upperLimit': '-98.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Dotarem® dialysability assessed 4h after second hemodialysis session which took place 2 days after Dotarem® administration', 'description': 'Evaluation of the decrease in seric concentration of gadolinium, 4h after the second hemodialysis session of patients injected with 0.1 mmol/kg of Dotarem®. The percent change of gadolinium concentration was estimated from the concentration of gadolinium after Dotarem® injection. Only subjects with gadolinium concentration above the lower limit of quantification (LLQ) were kept for analysis.', 'unitOfMeasure': 'Percent change in Gd concentration', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '3 subjects had a gadolinium concentration \\<LLQ after the second hemodialysis session'}, {'type': 'POST_HOC', 'title': 'Percent Change in Gadolinium Serum Concentration 4h After Third Hemodialysis Session, Estimated From Subjects With Concentration Data Above the Limit of Detection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dotarem® Injected Patients', 'description': 'Male or female, aged ≥18 years\n\n• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)'}], 'classes': [{'categories': [{'measurements': [{'value': '-99.7', 'groupId': 'OG000', 'lowerLimit': '-99.8', 'upperLimit': '-99.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Dotarem® dialysability assessed 4h after third hemodialysis session which took place 4 days after Dotarem® administration', 'description': 'The evaluation of the decrease in seric concentration of gadolinium, 4h after the third hemodialysis session of patients injected with 0.1 mmol/kg of Dotarem®. The percent change of gadolinium concentration was estimated from the concentration of gadolinium after Dotarem® injection. Only subjects with gadolinium concentration above the lower limit of detection were kept for analysis.', 'unitOfMeasure': 'percent change in Gd concentration', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '8 subjects had a gadolinium concentration \\<LLQ after third hemodialysis session'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dotarem® Injected Patients', 'description': 'Male or female, aged ≥18 years\n\n• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)\n\nDotarem®: Dotarem® was administered at a dose of 0.1 mmoL/kg (0.2 mL/kg).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Dotarem®-Injected Patients', 'description': 'Male or female, aged ≥18 years\n\n• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)\n\nDotarem®: Dotarem® was administered at a dose of 0.1 mmoL/kg (0.2 mL/kg).'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.0', 'groupId': 'BG000', 'lowerLimit': '31', 'upperLimit': '79'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belgium', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'No statistical calculation of sample size was done. According to the literature, a sample of 10 patients was judged sufficient to evaluate the dialysability of Dotarem®.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-09', 'studyFirstSubmitDate': '2011-10-03', 'resultsFirstSubmitDate': '2015-02-19', 'studyFirstSubmitQcDate': '2011-10-06', 'lastUpdatePostDateStruct': {'date': '2015-07-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-05-21', 'studyFirstPostDateStruct': {'date': '2011-10-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dialysability of Dotarem® in Dialysed Patients', 'timeFrame': 'Dotarem® dialysability assessed up to 4 days after Dotarem® administration', 'description': 'To evaluate the decrease in seric concentration of gadolinium, after each hemodialysis session of patients injected with 0.1 mmol/kg of Dotarem® . The percent change of gadolinium concentration is calculated by estimating the amount of serum gadolinium before and after each hemodialysis session. Calculations are performed only for subjects with concentration above the lower limit of quantification (LLQ)'}], 'secondaryOutcomes': [{'measure': 'Safety of Dotarem® in Dialysed Patients Evaluated by the Number of Patients Experiencing Adverse Events.', 'timeFrame': 'Safety assessed from patients inclusion until the last follow-up visit 3 months after Dotarem® administration', 'description': 'To evaluate the biological and clinical safety of Dotarem® by assessing vital signs, biological parameters, injection-site tolerance, through a 4-day post injection follow-up, adverse events through a 3-week post injection period and serious adverse events through a 3-month post injection period.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dotarem', 'Dialyses', 'Dialysed', 'Safety', 'Safety and dialysability of Dotarem in dialysed patients'], 'conditions': ['End-stage Renal Failure']}, 'descriptionModule': {'briefSummary': 'To evaluate the dialysability of Dotarem®, after an IV injection of 0.1 mmol/kg in patients with chronic renal failure who require hemodialysis treatment.', 'detailedDescription': 'Ten adult patients suffering from end stage renal failure and requiring hemodialysis treatment for 3 times were enrolled. Patients received a single dose of Dotarem® at 0.1 mmol/kg before being submitted to hemodialysis to assess the dialysability of Dotarem® . After injection of Dotarem®, 3 sessions of hemodialysis were performed as follows:\n\nThe first hemodialysis session started between 1 to 2 h after the injection; The second hemodialysis session occurred 2 days (i.e., 48 ± 2 h) after the Dotarem® injection; The third hemodialysis session occurred 4 days (i.e., 96 ± 4 h) after the Dotarem® injection.\n\nThe decrease in serum Dotarem® concentration was assessed after each hemodialysis session. Safety assessments included adverse events (AEs), vital signs, injection-site tolerance, and laboratory assessments.Two safety follow-up visits were performed: one 3 weeks (± 2 days) and one 3 months (± 4 days) after the Dotarem® injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale or female, aged ≥18 years\n\n* Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)\n* Female Subjects with effective contraception (contraceptive pill or Intra-Uterine Device), or surgically sterilized or post-menopausal (minimum 12 months amenorrhea)\n* Subjects having provided their written informed consent to participate in the trial\n\nExclusion Criteria:\n\n* Known allergy to gadolinium chelates\n* Pregnant, breast feeding, or planning to become pregnant during the trial\n* Having received or scheduled to be injected with any contrast agent within 7 days before or after the Dotarem® injection\n* Schedule to receive erythropoietin (EPO) or iron therapy during 1 week after the Dotarem® injection\n* Evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies\n* Evidence of hepatitis C and/or positive hepatitis C antibody and/or positive hepatitis B surface antigen\n* History of hypersensitivity to drugs with a similar chemical structure'}, 'identificationModule': {'nctId': 'NCT01449266', 'briefTitle': 'Safety and Dialysability of Dotarem® in Dialysed Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guerbet'}, 'officialTitle': 'Safety and Dialysability of Dotarem® in Dialysed Patients - Phase 1 Clinical Study', 'orgStudyIdInfo': {'id': 'DGD-44-054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Dotarem®-injected patients', 'description': 'Male or female subjects, aged ≥18 years,suffering from end-stage renal failure and requiring hemodialysis treatment 3 times per week, were submitted to a single Dotarem® IV injection at 0.1 mmol/kg before being submitted to 3 hemodialysis sessions to assess the decrease of Dotarem® concentration in the blood.', 'interventionNames': ['Drug: Dotarem® IV injection at 0.1 mmol/kg']}], 'interventions': [{'name': 'Dotarem® IV injection at 0.1 mmol/kg', 'type': 'DRUG', 'otherNames': ['gadoterate meglumine', 'gadoteric acid'], 'description': 'Dotarem® was IV administered at a dose of 0.1 mmoL/kg (0.2 mL/kg).', 'armGroupLabels': ['Dotarem®-injected patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Clinical Pharmacology Unit Antwerp', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}], 'overallOfficials': [{'name': 'Sofie Mesens, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Pharmacology Unit Antwerp, Belgium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guerbet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}