Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2026-01-07 @ 2:12 AM
Study NCT ID:
NCT04072432
Status:
COMPLETED
Last Update Posted:
2024-11-19
First Post:
2019-08-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of RBT-3 in Healthy Volunteers and Volunteers With Stage 3/4 Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], '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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sruiz@renibus.com', 'phone': '424-209-2734', 'title': 'Stacey Ruiz, PhD / VP, Drug Development', 'organization': 'Renibus Therapeutics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '8 days', 'eventGroups': [{'id': 'EG000', 'title': '120 mg', 'description': 'Single IV infusion', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '240 mg', 'description': 'Single IV infusion', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '360 mg', 'description': 'Single IV infusion', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Mild Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Effect of RBT-3 on Plasma Ferritin Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg', 'description': 'Single IV infusion'}, {'id': 'OG001', 'title': '240 mg', 'description': 'Single IV infusion'}, {'id': 'OG002', 'title': '360 mg', 'description': 'Single IV infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '2.49', 'groupId': 'OG000', 'lowerLimit': '1.94', 'upperLimit': '3.19'}, {'value': '4.42', 'groupId': 'OG001', 'lowerLimit': '3.45', 'upperLimit': '5.66'}, {'value': '4.90', 'groupId': 'OG002', 'lowerLimit': '3.82', 'upperLimit': '6.28'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 hours post-infusion', 'unitOfMeasure': 'Ratio (24 h post-infusion over baseline)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Effect of RBT-3 on Plasma HO-1 Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg', 'description': 'Single IV infusion'}, {'id': 'OG001', 'title': '240 mg', 'description': 'Single IV infusion'}, {'id': 'OG002', 'title': '360 mg', 'description': 'Single IV infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0171', 'groupId': 'OG000', 'lowerLimit': '-0.694', 'upperLimit': '0.728'}, {'value': '-0.7086', 'groupId': 'OG001', 'lowerLimit': '-1.419', 'upperLimit': '0.002'}, {'value': '-0.0641', 'groupId': 'OG002', 'lowerLimit': '-0.775', 'upperLimit': '0.646'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 hours post-infusion', 'unitOfMeasure': 'Ratio (24 h post-infusion over baseline)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '120 mg', 'description': 'Single IV infusion'}, {'id': 'FG001', 'title': '240 mg', 'description': 'Single IV infusion'}, {'id': 'FG002', 'title': '360 mg', 'description': 'Single IV infusion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '120 mg', 'description': 'Single IV infusion'}, {'id': 'BG001', 'title': '240 mg', 'description': 'Single IV infusion'}, {'id': 'BG002', 'title': '360 mg', 'description': 'Single IV infusion'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'spread': '7.32', 'groupId': 'BG000'}, {'value': '57.7', 'spread': '14.87', 'groupId': 'BG001'}, {'value': '63.3', 'spread': '11.83', 'groupId': 'BG002'}, {'value': '60.3', 'spread': '11.30', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-05', 'size': 8634437, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_004.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-12-01T22:05', 'hasProtocol': True}, {'date': '2019-04-25', 'size': 799344, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_005.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-12-01T22:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-14', 'studyFirstSubmitDate': '2019-08-26', 'resultsFirstSubmitDate': '2020-01-31', 'studyFirstSubmitQcDate': '2019-08-26', 'lastUpdatePostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-18', 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of RBT-3 on Plasma Ferritin Levels', 'timeFrame': '24 hours post-infusion'}, {'measure': 'Effect of RBT-3 on Plasma HO-1 Levels', 'timeFrame': '24 hours post-infusion'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers', 'Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1b, single center, dose-escalating study evaluating the safety, tolerability, and pharmacodynamic effect of RBT-3 in healthy volunteers and in subjects with stage 3-4 chronic kidney disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male and female subjects age 18 to 80 years (inclusive, at time of ICF).\n2. Body weight \\<125 kg.\n3. Able and willing to comply with all study procedures.\n4. Female subjects must be either post-menopausal for at least 1 year or surgically sterile (tubal ligation, hysterectomy or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use dual methods of contraception, or abstain from sexual activity from Screening until 8 days after study drug administration.\n\n Male subjects with female partners of childbearing potential must agree to use a highly effective method of contraception from screening until 8 days after study drug administration. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant (e.g., missed or late menstrual period) at any time during study participation.\n5. CKD as determined by estimated glomerular filtration rate (eGFR) between 15-59 ml/min as estimated using the CKD-EPI equation (CKD class 3-4).\n\nExclusion Criteria:\n\n1. History of malignancy except carcinoma in situ in the cervix, early stage prostate cancer or non-melanoma skin cancers.\n2. Use of investigational drugs or participation in another clinical trial within 30 days or 5 half-lives prior to screening, whichever is longer.\n3. Serum ferritin \\> 500 ng/ml or who have received IV iron within 28 days of screening.\n4. Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.\n5. Any significant acute or chronic diseases, excluding CKD (eGFR ≥15 ml/min).\n6. Regular use of drugs of abuse and/or positive findings on urinary drug screening.\n7. Current tobacco use and/or positive findings on urinary cotinine screening.\n8. Subjects who are severely physically or mentally incapacitated and who, in the opinion of investigator, are unable to perform the subjects' tasks associated with the protocol.\n9. Presence of any condition which, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated.\n10. Known hypersensitivity or previous anaphylaxis to FeS."}, 'identificationModule': {'nctId': 'NCT04072432', 'briefTitle': 'A Study of RBT-3 in Healthy Volunteers and Volunteers With Stage 3/4 Chronic Kidney Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Renibus Therapeutics, Inc.'}, 'officialTitle': 'A Phase 1b Dose-escalating Study With RBT-3 in Healthy Volunteers and Volunteers With Chronic Kidney Disease Stage 3/4', 'orgStudyIdInfo': {'id': 'REN-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '120 mg', 'interventionNames': ['Drug: RBT-3']}, {'type': 'EXPERIMENTAL', 'label': '240 mg', 'interventionNames': ['Drug: RBT-3']}, {'type': 'EXPERIMENTAL', 'label': '360 mg', 'interventionNames': ['Drug: RBT-3']}], 'interventions': [{'name': 'RBT-3', 'type': 'DRUG', 'description': 'intravenous administration', 'armGroupLabels': ['120 mg', '240 mg', '360 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32132', 'city': 'Edgewater', 'state': 'Florida', 'country': 'United States', 'facility': 'Riverside Clinical Research', 'geoPoint': {'lat': 28.98888, 'lon': -80.90228}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Renibus Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}