Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-30 @ 10:06 PM
Study NCT ID:
NCT04409132
Status:
COMPLETED
Last Update Posted:
2021-07-13
First Post:
2020-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C049051', 'term': 'ferric pyrophosphate'}, {'id': 'C032360', 'term': 'spleen fibrinolytic proteinase (human)'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-12', 'studyFirstSubmitDate': '2020-05-26', 'studyFirstSubmitQcDate': '2020-05-26', 'lastUpdatePostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under plasma concentration-time curve (AUC0-last pFetotal) for all Treatments A,B,C and D', 'timeFrame': '8 hours'}, {'measure': 'Area under plasma transferrin bound plasma iron concentration- time curve (AUC0-last FeTBI) for all Treatments A,B,C and D', 'timeFrame': '8 hours'}], 'secondaryOutcomes': [{'measure': 'Maximum observed plasma iron concentration (Cmax pFetotal) for all Treatments A,B,C and D', 'timeFrame': '8 hours'}, {'measure': 'Maximum observed transferrin bound plasma iron concentration (Cmax FeTBI) for all Treatments A,B,C and D', 'timeFrame': '8 hours'}, {'measure': 'Maximum observed serum iron concentration (Cmax sFetotal) for all Treatments A,B,C and D', 'timeFrame': '8 hours'}, {'measure': 'Area under serum Fe concentration-time curve (AUC0-last sFetotal) for all Treatments A,B,C and D', 'timeFrame': '8 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pharmacokinetics'], 'conditions': ['End Stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'This study will investigate the administration of Triferic AVNU intravenously by three different administration schedules compared to continuous infusion over 3 hours', 'detailedDescription': 'An open-label, randomized, four period sequential study of Triferic AVNU administered intravenously by three different administration schedules compared to continuous infusion over 3 hours'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult hemodialysis patients ≥18 years of age.\n* Signed informed consent to participate in the study.\n* Stable on hemodialysis prescription for ≥3 months.\n* Able to sustain hemodialysis 3x/week for 3 to 4 hours.\n* Hemoglobin concentration \\>9.5 g/dL.\n* Serum TSAT ≥20%.\n* Receiving hemodialysis via AV fistula or graft.\n* Able to receive hemodialysis for 4 hours at each session over the duration of the treatment periods.\n* Able to receive intermittent heparin administration for anticoagulation of the dialysis circuit.\n* Serum TIBC ≥ 150 µg/dL.\n\nExclusion Criteria:\n\n* Active bleeding disorder (GI, skin, nasal…)\n* Receiving hemodialysis via catheter.\n* Receiving IV iron within 10 days of the first on-study hemodialysis treatment.\n* Receiving oral iron within 10 days of the first on-study hemodialysis treatment.\n* Any other condition, that in the opinion of the investigator would not allow completion of the 4 hemodialysis treatments in the study.'}, 'identificationModule': {'nctId': 'NCT04409132', 'briefTitle': 'Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rockwell Medical Technologies, Inc.'}, 'officialTitle': 'A Randomized 4 Period Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.', 'orgStudyIdInfo': {'id': 'RMFPC-26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Triferic AVNU infusion pre-dialyzer', 'description': 'Patients will receive one (1) 6.75 mg Fe dose of Triferic AVNU by continuous infusion over 3 hours into the predialyzer blood line.', 'interventionNames': ['Drug: Triferic']}, {'type': 'EXPERIMENTAL', 'label': 'Triferic AVNU for injection at T=0 and T= 3 hours', 'description': 'Patients will receive two (2) doses of Triferic AVNU 3.4 mg IV (2.25 mL) at T=0 and T=3 hours of hemodialysis into the venous drip chamber.', 'interventionNames': ['Drug: Triferic']}, {'type': 'EXPERIMENTAL', 'label': 'Triferic AVNU for injection at T=0', 'description': 'Patients will receive one (1) dose of Triferic AVNU 0.08 mg/kg IV, up to 6.75 mg Fe, at T=0 of hemodialysis into the venous drip chamber.', 'interventionNames': ['Drug: Triferic']}, {'type': 'EXPERIMENTAL', 'label': 'Triferic AVNU for injection at T=0, T=1.5 and T= 3 hours', 'description': 'Patients will receive three (3) doses of Triferic AVNU 2.25 mg Fe (1.5 mL) at T=0, T=1.5 and T=3.0 hours of hemodialysis into the venous drip chamber.', 'interventionNames': ['Drug: Triferic']}], 'interventions': [{'name': 'Triferic', 'type': 'DRUG', 'otherNames': ['ferric pyrophosphate citrate', 'FPC'], 'description': 'Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.', 'armGroupLabels': ['Triferic AVNU for injection at T=0', 'Triferic AVNU for injection at T=0 and T= 3 hours', 'Triferic AVNU for injection at T=0, T=1.5 and T= 3 hours', 'Triferic AVNU infusion pre-dialyzer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Clinical Research Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'overallOfficials': [{'name': 'Raymond D Pratt, MD, FACP', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rockwell Medical'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rockwell Medical Technologies, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}