Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-02-24 @ 3:13 PM
Study NCT ID:
NCT03018067
Status:
TERMINATED
Last Update Posted:
2019-12-26
First Post:
2017-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006947', 'term': 'Hyperkalemia'}], 'ancestors': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'whyStopped': 'Sponsor stopped program\\]', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-23', 'studyFirstSubmitDate': '2017-01-10', 'studyFirstSubmitQcDate': '2017-01-10', 'lastUpdatePostDateStruct': {'date': '2019-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exponential Rate of Change in Serum Potassium from Baseline', 'timeFrame': '48 hours', 'description': 'Onset of Action'}], 'secondaryOutcomes': [{'measure': 'Change in Serum Potassium Levels', 'timeFrame': '7 days'}, {'measure': 'Incidence of Treatment - Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hyperkalemia']}, 'descriptionModule': {'briefSummary': 'This phase 2, single-blind, placebo-controlled study will evaluate the onset-of-action, safety, and efficacy of RDX227675 for the treatment of hyperkalemia. Subjects who qualify are randomized into one of four treatment groups: Group 1 (Placebo qd), Group 2 (RDX227675 10 g qd), Group 3 (RDX227675 20 g qd), Group 4 (RDX227675 30 g qd).', 'detailedDescription': 'The study consists of a screening visit, a 7-day treatment period, and a 7-day treatment-free follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 85 years old, inclusive\n* Two consecutive i-STAT K values ≥ 5.5 to \\< 6.5 mmol/L, measured a minimum of 60-minutes apart within 1 day of first RDX227675 dose on Day 1 (prior to randomization)\n* i-STAT K value ≥ 5.5 to \\< 6.5 mmol/L on Day 1 (prior to randomization)\n* Ability to have repeated blood draws or effective venous catheterization\n* Females of child bearing potential must have negative urine pregnancy test on Day 1 (prior to randomization)\n* Females but be non-pregnant, non-lactating, and either be post-menopausal for at least 12 months, have documentation of irreversible surgical sterilization, or confirm the use of one of the acceptable contraceptive methods\n* Males must agree to use an appropriate method of contraception or have documented surgical sterilization\n\nExclusion Criteria:\n\n* Pseudohyperkalemia signs and symptoms\n* Treatment with K lowering drugs, within 7 days prior to randomization\n* Uncontrolled Type 2 diabetes, as defined as most recent historical HbA1c \\> 10%, or hospitalization to treat hyper- or hypo-glycemia in the past 3 months\n* Diabetic ketoacidosis\n* Known hypersensitivity to polystyrene sulfonate\n* Significant cardiovascular or cerebrovascular events in the past 2 months\n* Severe heart failure, defined as NYHA (New York Heart Association) class IV or hospitalization to treat heart failure in previous 3 months\n* History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders, or major gastrointestinal surgery\n* Major psychiatric disorder (DSM-III-R or DSM-IV) including major depression or other psychoses that has required hospitalization in the last 3 years. History of attempted suicide or uncontrolled bipolar disorder.\n* Use of an investigational product within 30 days prior to Screening'}, 'identificationModule': {'nctId': 'NCT03018067', 'briefTitle': 'A Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ardelyx'}, 'officialTitle': 'A Single-Blind, Placebo-Controlled Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia', 'orgStudyIdInfo': {'id': 'RDX227675-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Microcrystalline Cellulose (MCC), 2 g qd. Subjects assigned to the Placebo group will be randomly assigned in a 1:1:1 ratio to receive either one, two, or three bottles of drug per day.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '10 g qd', 'description': 'RDX227675, 10 g qd', 'interventionNames': ['Drug: RDX227675']}, {'type': 'EXPERIMENTAL', 'label': '20 g qd', 'description': 'RDX227675, 20 g qd', 'interventionNames': ['Drug: RDX227675']}, {'type': 'EXPERIMENTAL', 'label': '30 g qd', 'description': 'RDX227675, 30 g qd', 'interventionNames': ['Drug: RDX227675']}], 'interventions': [{'name': 'RDX227675', 'type': 'DRUG', 'armGroupLabels': ['10 g qd', '20 g qd', '30 g qd']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27511', 'city': 'Cary', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Capital Nephrology Associates, PA', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}], 'overallOfficials': [{'name': 'David P Rosenbaum, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Ardelyx, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ardelyx', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}