Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-24 @ 9:06 PM
Study NCT ID:
NCT02469467
Status:
UNKNOWN
Last Update Posted:
2016-02-08
First Post:
2015-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dose Escalation Study of VS-505 in End Stage Renal Disease Patients Undergoing Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D054559', 'term': 'Hyperphosphatemia'}], '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'}, {'id': 'D010760', 'term': 'Phosphorus Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-04', 'studyFirstSubmitDate': '2015-06-01', 'studyFirstSubmitQcDate': '2015-06-08', 'lastUpdatePostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inorganic phosphorus (Pi) change from baseline to end of treatment', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Calcium (Ca) change from baseline to end of treatment', 'timeFrame': '8 weeks'}, {'measure': 'Ca x Pi change from baseline to end of treatment', 'timeFrame': '8 weeks'}, {'measure': 'intact parathyroid hormone change from baseline to end of treatment', 'timeFrame': '8 weeks'}, {'measure': 'Rate of patients whose Pi reduction is 0.65 mmol/L (2.0 mg/dL)', 'timeFrame': '8 weeks'}, {'measure': 'Rate of patients whose Pi reaches the goal between 1.13 mmol/L (3.5 mg/dL) and 1.94 mmol/L (6.0 mg/dL)', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['phosphate binder', 'dialysis'], 'conditions': ['End Stage Renal Disease', 'Hyperphosphatemia']}, 'descriptionModule': {'briefSummary': 'The purpose is to evaluate the tolerability, safety and efficacy of VS-505 when given with meal for 8 weeks to hemodialysis patients with hyperphosphatemia', 'detailedDescription': 'This study consists of 4 period; 1) screening period: up to 30 days, 2) first washout period: 2 weeks (remove existing phosphate binder effect), 3) treatment period: 8 weeks, and 4) second washout period: 2 weeks (remove VS-505 effect). VS-505 is orally administered with meal for 8 weeks. The starting dose of VS-505 is 1.50 g/day and the dose will be elevated step wise from 1.50 g to 2.25 g, 4.50 g and 6.75 g per day based on the safety assessment and plasma Pi level every 2 weeks during the treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent given\n* Able to comply with the study procedures and medications\n* On a stable hemodialysis (HD) regimen (3 times per week) including hemodialysis and hemodiafiltration for ≥12 weeks at screening and during the study period\n* No change in prescribed dose or frequency of any of the following medications within 4 weeks prior to screening\n\n 1. Injectable iron agents\n 2. Oral or injectable active vitamin D3\n 3. Oral nutritional vitamin D\n 4. Calcimimetics\n 5. Calcium supplements\n 6. Anti-osteoporotic medication including bisphosphonates\n 7. Calcitonins\n* Must be willing to avoid intentional changes in diet throughout the study\n* Women of child-bearing potential or non-sterile male subjects and those who are sexually active with a non-sterile female partner must agree to use highly effective contraception\n* Plasma Pi level \\>1.94 mmol/L (6.0 mg/dL) to \\<3.23 mmol/L (10.0 mg/dL) after 2 weeks washout will qualify patients to enter the treatment period\n\nExclusion Criteria:\n\n* Blood purification therapy other than HD (hemodialysis and hemodiafiltration)\n* The plasma Pi level is \\>2.26 mmol/L (7.0 mg/dL) within the latest three tests prior to screening.\n* Variation of the plasma Pi is over 0.65 mmol/L (2.0 mg/dL) within the latest three tests prior to screening.\n* Pre-emptive or scheduled renal transplant\n* History of hemochromatosis or ferritin ≥1000 mcg/L\n* Oral iron agents including prescribed and over-the-counter drugs at screening.\n* Current clinically significant gastrointestinal (GI) disorder, including GI bleeding, colitis, inflammatory bowel disease, irritable bowel syndrome, chronic constipation, new diagnosis of peptic or duodenal ulcer disease, within 4 weeks prior to screening\n* History of gastrectomy or duodenectomy, or GI tract surgery within 12 weeks prior to screening\n* Hypertension: Defined using pre-dialysis vital of diastolic blood pressure \\>110 mmHg or systolic blood pressure \\>180 mmHg\n* Possible parathyroid intervention including surgical parathyroidectomy and percutaneous ethanol injection therapy during the study period\n* Clinical evidence of active malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous carcinoma of the skin\n* Severe cardiovascular disorders such as recent myocardial infarction; unstable angina; congested heart failure (NYHA class II or above) hospitalized within 24 weeks (6 months), valve stenosis, atrial fibrillation and arrhythmia\n* History of event by cerebrovascular disease or cardiovascular disease within 24 weeks (6 months) prior to screening\n* Active infection or current treatment with antibiotics within 2 weeks prior to screening\n* History of HIV (ELISA and Western blot) test results\n* Known active liver disease with aspartate aminotransferase or alanine aminotransferase levels greater than x3 the upper limit of normal\n* Hepatitis B and/or hepatitis C treated with antiviral treatment within 4 weeks prior to screening\n* History of allergy of VS-505 and its related components\n* Receipt of any investigational drug within 4 weeks prior to screening\n* Pregnant and breast-feeding women\n* Other patients who in the opinion of the investigators are ineligible for the study'}, 'identificationModule': {'nctId': 'NCT02469467', 'briefTitle': 'A Dose Escalation Study of VS-505 in End Stage Renal Disease Patients Undergoing Hemodialysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'KDL Inc.'}, 'officialTitle': 'A Dose Escalation Study of VS-505 to Evaluate the Tolerability, Safety and Efficacy in End Stage Renal Disease Patients Undergoing Hemodialysis', 'orgStudyIdInfo': {'id': 'VDKDL001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VS-505', 'description': '750 mg capsule', 'interventionNames': ['Dietary Supplement: VS-505']}], 'interventions': [{'name': 'VS-505', 'type': 'DIETARY_SUPPLEMENT', 'description': 'VS-505 is orally administered with meal for 8 weeks', 'armGroupLabels': ['VS-505']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Perth', 'state': 'Western Australia', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'LCR Clinical Research', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}], 'centralContacts': [{'name': 'KDL inc', 'role': 'CONTACT', 'email': 'asao@kdl-japan.com', 'phone': '+81-3-3234-3400'}], 'overallOfficials': [{'name': 'Johan Rosman, MD, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LCR Clinical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KDL Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}