Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-30 @ 10:59 PM
Study NCT ID:
NCT06864104
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate Tonlamarsen for the Treatment of Adults With Uncontrolled Hypertension (KARDINAL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Once eligibility is confirmed during screening, there will be two run-in periods (Part A and Part B). Eligible participants will then be randomized to tonlamarsen or placebo (Part C).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 206}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-03-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2025-02-12', 'studyFirstSubmitQcDate': '2025-03-03', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the effect of tonlamarsen on plasma angiotensinogen (AGT) levels', 'timeFrame': 'Week 20', 'description': 'Percent Change from baseline (Week 0) in plasma angiotensinogen (AGT) levels to Week 20'}, {'measure': 'To assess the systolic blood pressure-lowering efficacy of tonlamarsen', 'timeFrame': 'Week 20', 'description': 'Change from baseline (Week 0) in mean office seated systolic blood pressure to Week 20'}], 'secondaryOutcomes': [{'measure': 'To assess the safety and tolerability of tonlamarsen', 'timeFrame': 'Week 28', 'description': 'Incidence and severity of treatment emergent adverse events (TEAEs). Incidence of clinically significant abnormalities in laboratory assessments, ECGs and vital signs. Incidence of: (1) Hyperkalemia, defined as serum potassium \\>5.5 mmol/L. (2) Hypotension, defined as systolic blood pressure \\<90 mmHg, or systolic blood pressure \\<100 mmHg and symptomatic and/or requiring clinical intervention. (3) Renal dysfunction, defined as a decrease of eGFR \\>30% from baseline value. (4) Increased proteinuria, defined as UPCR \\>0.5 mg/mg from baseline value.'}, {'measure': 'To assess the efficacy of tonlamarsen in achieving office seated systolic blood pressure <130 mmHg', 'timeFrame': 'Week 20', 'description': 'Proportion of participants with mean office seated systolic blood pressure \\<130 mmHg at Week 20'}, {'measure': 'To assess the systolic blood pressure-lowering efficacy of tonlamarsen', 'timeFrame': 'Week 20', 'description': 'Change from baseline (Week 0) in mean self-assessed home systolic blood pressure through Week 20'}, {'measure': 'To assess the effect of tonlamarsen on severe systolic blood pressure elevations', 'timeFrame': 'Week 20', 'description': 'Proportion of participants with any daily average home systolic blood pressure ≥150 mmHg at Week 20'}, {'measure': 'To assess the diastolic blood pressure-lowering efficacy of tonlamarsen', 'timeFrame': 'Week 20', 'description': 'Change from baseline (Week 0) in mean office seated diastolic blood pressure to Week 20'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the blood pressure (BP)-lowering efficacy of tonlamarsen in adult participants who, despite taking 2 or more antihypertensive medications, have not achieved their target blood pressure (BP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Age 18 to 80, body weight ≥ 50 kg\n* Has uncontrolled hypertension while receiving between 2 and 5 antihypertensive medications prescribed for hypertension\n* Has mean office seated systolic blood pressure \\> 135 to ≤ 170 mmHg\n\nKey Exclusion Criteria:\n\n* Has known history of secondary hypertension\n* Has documented history of poor adherence to antihypertensive medication\n* Has unstable/underlying known cardiovascular disease\n* Has abnormal thyroid function with clinical significance'}, 'identificationModule': {'nctId': 'NCT06864104', 'briefTitle': 'A Study to Investigate Tonlamarsen for the Treatment of Adults With Uncontrolled Hypertension (KARDINAL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kardigan, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Monthly Subcutaneous Administration of Tonlamarsen in Participants With Uncontrolled Hypertension (KARDINAL)', 'orgStudyIdInfo': {'id': 'TLA-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tonlamarsen', 'description': '1 dose of placebo and 5 doses of active drug will be administered by subcutaneous (SC) injection', 'interventionNames': ['Drug: Tonlamarsen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '5 doses of placebo and 1 dose of active drug will be administered by subcutaneous (SC) injection', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tonlamarsen', 'type': 'DRUG', 'description': 'Tonlamarsen will be administered subcutaneously (SC) every 4 weeks during the randomized part of the study', 'armGroupLabels': ['Tonlamarsen']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be administered subcutaneously (SC) every 4 weeks during the randomized part of the study', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pinnacle Research Group', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Achieve Clinical Research, LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Elite Clinical Studies', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85715', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Del Sol Research Management, LLC', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72204', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Cardiology and Medicine Clinic', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'North Coast Cardiology', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '92630', 'city': 'Lake Forest', 'state': 'California', 'country': 'United States', 'facility': 'Orange County Research Center', 'geoPoint': {'lat': 33.64697, 'lon': -117.68922}}, {'zip': '95648', 'city': 'Lincoln', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Trials Research', 'geoPoint': {'lat': 38.89156, 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'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Agile Clinical Research Trials, LLC', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Velocity Clinical Reseach', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '60621', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Eagle Clinical Research', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60031', 'city': 'Gurnee', 'state': 'Illinois', 'country': 'United States', 'facility': 'Clinical Investigation Specialists, Inc.', 'geoPoint': {'lat': 42.3703, 'lon': -87.90202}}, {'zip': '61550', 'city': 'Morton', 'state': 'Illinois', 'country': 'United States', 'facility': 'Koch Family Medicine Clinical Research', 'geoPoint': {'lat': 40.61282, 'lon': -89.45926}}, {'zip': '70072', 'city': 'Marrero', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tandem Clinical 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{'zip': '10310', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Richmond University Medical Center', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '10455', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'CHEAR Center LLC', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '28645', 'city': 'Lenoir', 'state': 'North Carolina', 'country': 'United States', 'facility': 'IMA Clinical Research', 'geoPoint': {'lat': 35.91402, 'lon': -81.53898}}, {'zip': '29461', 'city': 'Moncks Corner', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Clinical Trials of South Carolina', 'geoPoint': {'lat': 33.19632, 'lon': -80.01429}}, {'zip': '57702', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Health Concepts', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '37660', 'city': 'Kingsport', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Holston Medical Group', 'geoPoint': {'lat': 36.54843, 'lon': -82.56182}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Central Texas Clinical Research', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78628', 'city': 'Georgetown', 'state': 'Texas', 'country': 'United States', 'facility': 'Advanced Medical Trials, LLC', 'geoPoint': {'lat': 30.63269, 'lon': -97.67723}}, {'zip': '77040', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Juno Research, LLC', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '76550', 'city': 'Lampasas', 'state': 'Texas', 'country': 'United States', 'facility': 'Radiance Clinical Research', 'geoPoint': {'lat': 31.06378, 'lon': -98.1817}}, {'zip': '77459', 'city': 'Missouri City', 'state': 'Texas', 'country': 'United States', 'facility': 'Synergy Groups Medical, LLC', 'geoPoint': {'lat': 29.61857, 'lon': -95.53772}}, {'zip': '76180', 'city': 'North 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