Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2026-02-21 @ 6:45 PM
Study NCT ID:
NCT03150420
Status:
TERMINATED
Last Update Posted:
2020-05-19
First Post:
2017-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 3 Clinical Trial of Intravenous Sodium Thiosulfate in Acute Calciphylaxis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002115', 'term': 'Calciphylaxis'}, {'id': 'D002114', 'term': 'Calcinosis'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C017717', 'term': 'sodium thiosulfate'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'whyStopped': 'Inability to accrue subjects that met the exclusion criterion "Any prior (within the past 30 days) or current Sodium Thiosulfate treatment".', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-15', 'studyFirstSubmitDate': '2017-03-29', 'studyFirstSubmitQcDate': '2017-05-11', 'lastUpdatePostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with 30% improvement in pain severity', 'timeFrame': 'randomization to 3 weeks', 'description': 'To compare the effects of treatment with intravenous Sodium Thiosulfate Injection vs. placebo for the proportion of patients (responders) who achieve a ≥ 30% reduction based upon pain intensity score (modified BPI/SF).'}], 'secondaryOutcomes': [{'measure': 'Secondary Endpoint-a: Number of patients with stabilization or improvement in calciphylaxis skin lesions.', 'timeFrame': 'randomization to 3 weeks', 'description': 'Proportion of patients who achieve improvement or stabilization (i.e., not worsening) of skin lesions.'}, {'measure': 'Secondary Endpoint-b: Occurence of surgical debridement of skin lesions and/or amputation.', 'timeFrame': 'during week 3', 'description': 'Occurence of surgical debridement of skin lesions and/or amputation.'}, {'measure': 'Secondary Endpoint-c: Occurrence of surgical debridement of skin lesions and/or amputation.', 'timeFrame': 'randomization to 3 weeks', 'description': 'Occurrence of surgical debridement of skin lesions and/or amputation.'}, {'measure': 'Secondary Endpoint-d: Time to achieve ≥ 30% improvement in pain severity', 'timeFrame': 'randomization to 3 weeks', 'description': 'Time in days when a patient achieves a ≥ 30% improvement based upon pain intensity score (modified BPI/SF).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['calciphylaxis', 'calcific uremic arteriolopathy, calcinosis', 'calcium metabolism disorders', 'metabolic diseases', 'sodium thiosulfate'], 'conditions': ['Calciphylaxis']}, 'descriptionModule': {'briefSummary': 'This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of intravenous Sodium Thiosulfate Injection for treatment of acute calciphylaxis-associated pain in chronic hemodialysis patients.', 'detailedDescription': 'This Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of intravenous Sodium Thiosulfate Injection for treatment of acute calciphylaxis-associated pain in chronic hemodialysis patients. Acute calciphylaxis- associated pain intensity will be the primary outcome measure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed of the investigational nature of the study and sign written informed consent\n* Willing and able to adhere to all study-related procedures, including adherence to study medication regimen\n* Male or female ≥18 years old\n* End-stage renal disease on chronic hemodialysis\n* Calciphylaxis with active skin lesion(s) of any morphological appearance (including but not limited to livedo, induration, ulceration, etc.) and tissue histology review consistent with calciphylaxis diagnosis. Histological features consistent with calciphylaxis will include soft tissue calcification, microthrombosis, and/or fibrointimal hyperplasia of dermal arterioles\n* Acute pain associated with calciphylaxis lesions pain intensity score of ≥ 5 at initial screening on the modified BPI/SF scale\n* Women of childbearing potential must have a pregnancy test (urine or serum \\[if anuric\\]) at screening and not be pregnant and willing to use an acceptable method of contraception for the entire duration of the study (3 weeks)\n\nExclusion Criteria:\n\n* Peritoneal dialysis patients\n* Current congestive heart failure exacerbation\n* Baseline abnormalities related to QT prolongation (corrected QT interval \\> 470 ms), hypocalcemia (serum albumin-corrected calcium \\< 8 mg/dL ), metabolic acidosis (serum bicarbonate \\< 18 mmol/L, hypotension (resting systolic blood pressure while seated \\< 80), or interdialytic weight gain ≥ 4.0 kg\n* History of ventricular arrhythmias including ventricular fibrillation or ventricular tachycardia associated with shortness of breath, dizziness, hypotension, or syncope\n* Any prior (within the past 30 days) or current intravenous Sodium Thiosulfate Injection treatment\n* Other investigational agent (drug, biologic, or device) study within the past 30 days and/or for the duration of the trial\n* Pregnant or lactating women\n* History of allergy to sulfites, thiosulfate, or any component in Sodium Thiosulfate Injection (sulfa allergy is not an exclusion criterion)\n* Significant other acute or chronic concomitant diseases (including but not limited to hepatic, cardiovascular, pulmonary, or oncologic disease, sepsis, pulmonary edema, pulmonary embolism) that would be inconsistent with survival for at least 3 months\n* Other serious concurrent or recent medical or psychiatric condition which, in the opinion of the Investigator, makes the patient unsuitable for participation in this study\n* Ongoing application of dialysate admixed with iron salt e.g. ferric pyrophosphate during the entire trial period (patients who are on dialysate admixed with iron salt at screening are eligible if dialysate admixed with iron salt can be substituted with non-iron based dialysate and patients can be maintained on non-iron based dialysate therapy for the entire duration of trial period)\n* Recent (within 1 week) history of surgical parathyroidectomy or scheduled for surgical parathyroidectomy during the course of the study\n* History of opioid addiction'}, 'identificationModule': {'nctId': 'NCT03150420', 'acronym': 'CALISTA', 'briefTitle': 'A Phase 3 Clinical Trial of Intravenous Sodium Thiosulfate in Acute Calciphylaxis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hope Pharmaceuticals'}, 'officialTitle': 'A Phase 3, Intravenous Sodium Thiosulfate for Acute Calciphylaxis Treatment: A Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Trial', 'orgStudyIdInfo': {'id': 'ST-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sodium Thiosulfate', 'description': 'Sodium Thiosulfate Injection (25 grams sodium thiosulfate)', 'interventionNames': ['Drug: Sodium Thiosulfate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo-Normal Saline', 'description': '0.9% sodium chloride injection, USP (normal saline)', 'interventionNames': ['Drug: Placebo-Normal Saline']}], 'interventions': [{'name': 'Sodium Thiosulfate', 'type': 'DRUG', 'otherNames': ['Intravenous Sodium Thiosulfate Injection'], 'description': 'Intravenous Sodium Thiosulfate Injection (25 grams sodium thiosulfate) to be administered each hemodialysis session (3 times weekly) for 3 weeks', 'armGroupLabels': ['Sodium Thiosulfate']}, {'name': 'Placebo-Normal Saline', 'type': 'DRUG', 'otherNames': ['0.9% sodium chloride solution'], 'description': 'Placebo: to be administered each hemodialysis session (3 times weekly) for 3 weeks', 'armGroupLabels': ['Placebo-Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Medical Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Veterans Administration Medical Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'The Icahn School of Medicine at Mount Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '58122', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Sanford Health', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '02914', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Health System', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '24153', 'city': 'Salem', 'state': 'Virginia', 'country': 'United States', 'facility': 'Veterans Administration Medical Center', 'geoPoint': {'lat': 37.29347, 'lon': -80.05476}}, {'zip': 'T2W 1S7', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary Foothills Medical Center', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 1Z1', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'R2V 3M3', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Health Sciences Centre Winnipeg', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'K7L 2V7', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Kingston Health Sciences Centre', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'H2X 0A9', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre Hospitalier de l'Universite de Montreal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'M6 8HD', 'city': 'Salford', 'state': 'Manchester', 'country': 'United Kingdom', 'facility': 'Salford Royal Hospital NHS Foundation Trust', 'geoPoint': {'lat': 53.48771, 'lon': -2.29042}}, {'zip': 'W12 0HS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Hammersmith Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'OX3 7LE', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Churchill Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'SG1 4AB', 'city': 'Stevenage', 'country': 'United Kingdom', 'facility': 'Lister Hospital', 'geoPoint': {'lat': 51.90224, 'lon': -0.20256}}], 'overallOfficials': [{'name': 'Craig Sherman, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hope Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hope Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}