Ignite Creation Date:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2025-12-31 @ 9:37 PM
Study NCT ID:
NCT04551300
Status:
COMPLETED
Last Update Posted:
2022-10-18
First Post:
2020-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 2 Study to Evaluate the Safety and Efficacy of VS-505(AP301) to Treat Hyperphosphatemia in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054559', 'term': 'Hyperphosphatemia'}], 'ancestors': [{'id': 'D010760', 'term': 'Phosphorus Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069603', 'term': 'Sevelamer'}], 'ancestors': [{'id': 'D011073', 'term': 'Polyamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '4 different dosages of VS-505 in Comparison with Sevelamer Carbonate'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-17', 'studyFirstSubmitDate': '2020-08-31', 'studyFirstSubmitQcDate': '2020-09-10', 'lastUpdatePostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Serum ferritin change from baseline to end of treatment', 'timeFrame': '6 weeks'}, {'measure': 'Number of serious adverse events (SAEs)', 'timeFrame': '6 weeks'}], 'primaryOutcomes': [{'measure': 'Serum phosphorus change from baseline to end of treatment', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Time to serum phosphorus response，defined as serum phosphorus level decrease by 0.32 mmol/L（1 mg/dL）and serum phosphorus level below 1.78 mmol/L（5.5 mg/dL）', 'timeFrame': '6 weeks'}, {'measure': 'The achievement rate of subjects with serum phosphorus in the target range 1.13-1.78 mmol/L（3.5-5.5 mg/dL）by the end of treatment', 'timeFrame': '6 weeks'}, {'measure': 'Serum calcium change from baseline to end of treatment', 'timeFrame': '6 weeks'}, {'measure': 'Serum Ca×P change from baseline to end of treatment', 'timeFrame': '6 weeks'}, {'measure': 'Serum iPTH change from baseline to end of treatment', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperphosphatemia']}, 'referencesModule': {'references': [{'pmid': '38453435', 'type': 'DERIVED', 'citation': 'Zhuang B, Gan L, Liu B, Yuan W, Shi M, Peng A, Wang L, Chen X, Liu T, Zhang S, Wang S, Gao Q, Wang B, Zheng H, Liu C, Luo Y, Ye H, Lin H, Li Y, He Q, Zheng F, Luo P, Long G, Lu W, Li K, Yang J, Liu YC, Zhang Z, Li X, Zhang W, Zuo L. Tolerability, safety and efficacy of a novel phosphate binder VS-505 (AP301): a Phase 2 dose-escalation and dose-ranging study in patients undergoing maintenance hemodialysis. Nephrol Dial Transplant. 2024 Sep 27;39(10):1649-1661. doi: 10.1093/ndt/gfae053.'}]}, 'descriptionModule': {'briefSummary': 'A multi-center, open-label, parallel-design, active-controlled phase 2 study to evaluate the tolerability, safety and efficacy of various dosages of VS-505 compared with Sevelamer Carbonate when given orally with meal for 6 weeks to treat hyperphosphatemia in chronic kidney disease subjects receiving maintenance hemodialysis.', 'detailedDescription': 'The main body of this study has 5 intervention arms, 4 VS-505 treatment arms of various dosage plus 1 active control arm of Sevelamer Carbonate, each consists 25 subjects. Prior to this main part, a dose escalating cohort of 25 subjects is added to evaluate the tolerability of VS-505 in Chinese patient population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with end stage renal disease who are receiving a stable hemodialysis regimen (3 times per week) with sufficient dialysis adequacy;\n* Serum phosphorus level range from \\>1.94 mmol/L (6.0 mg/dL) to ≤3.23 mmol/L (10.0 mg/dL) at the end of washout phase.\n\nExclusion Criteria:\n\n* Kidney transplant patient or scheduled kidney transplant, or change to peritoneal dialysis, home hemodialysis or plan to relocate to another dialysis center during the study period；\n* Serum phosphorus level is \\<1.29 mmol/L（4.0 mg/dL) or \\>2.42 mmol/L（7.5 mg/dL) at screening, or documented to be \\>3.23 mmol/L（10 mg/dL) within the latest three month prior to screening (screening included);\n* Serum calcium level is \\<8 mg/dL or \\>11 mg/dL at the screening;\n* Serum immunoreactive parathyroid hormone (iPTH)\\>1000 pg/mL at the screening;\n* History of hemochromatosis or serum ferritin value ≥1000 μg/L at screening；\n* Current clinically significant gastrointestinal (GI) disorder, or history of intestine obstruction, gastrectomy or duodenectomy, or GI tract surgery within 12 weeks prior to screening;\n* Poorly controlled hypertension, cardiovascular disorders, and history of cerebrovascular disease or cardiovascular disease event within 24 weeks (6 months) prior to screening.'}, 'identificationModule': {'nctId': 'NCT04551300', 'briefTitle': 'A Phase 2 Study to Evaluate the Safety and Efficacy of VS-505(AP301) to Treat Hyperphosphatemia in Hemodialysis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Alebund Pharmaceuticals Limited'}, 'officialTitle': 'A Phase 2 Study to Evaluate the Safety and Efficacy of Escalated and Fixed Doses of VS-505(AP301) in Comparison With Sevelamer Carbonate to Treat Hyperphosphatemia in Chronic Kidney Disease Patients Receiving Hemodialysis', 'orgStudyIdInfo': {'id': 'APCKD001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VS-505 500mg', 'description': 'VS-505 500mg (two 250 mg capsules) oral administration three times a day with meal, daily total dosage 1500mg.', 'interventionNames': ['Drug: VS-505']}, {'type': 'EXPERIMENTAL', 'label': 'VS-505 750mg', 'description': 'VS-505 750mg (one 750 mg capsule) oral administration three times a day with meal, daily total dosage 2250mg.', 'interventionNames': ['Drug: VS-505']}, {'type': 'EXPERIMENTAL', 'label': 'VS-505 1500mg', 'description': 'VS-505 1500mg (two 750 mg capsules) oral administration three times a day with meal, daily total dosage 4500mg.', 'interventionNames': ['Drug: VS-505']}, {'type': 'EXPERIMENTAL', 'label': 'VS-505 2250mg', 'description': 'VS-505 2250mg (three 750 mg capsules) oral administration three times a day with meal, daily total dosage 6750mg.', 'interventionNames': ['Drug: VS-505']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sevelamer Carbonate 1600mg', 'description': 'Sevelamer Carbonate 1600mg (two 800mg pills) oral administration three times a day with meal, daily total dosage 4800mg.', 'interventionNames': ['Drug: Sevelamer Carbonate']}], 'interventions': [{'name': 'VS-505', 'type': 'DRUG', 'description': '4 dosages of experimental drug', 'armGroupLabels': ['VS-505 1500mg', 'VS-505 2250mg', 'VS-505 500mg', 'VS-505 750mg']}, {'name': 'Sevelamer Carbonate', 'type': 'DRUG', 'otherNames': ['Renvela'], 'description': 'Active Comparator', 'armGroupLabels': ['Sevelamer Carbonate 1600mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Xiamen', 'state': 'Fujian', 'country': 'China', 'facility': 'Zhongshan Hospital Xiamen University', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'city': 'Guilin', 'state': 'Guangxi', 'country': 'China', 'facility': 'Affiliated Hospital of Guilin Medical University', 'geoPoint': {'lat': 25.28022, 'lon': 110.29639}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'The Third Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Xingtai', 'state': 'Hebei', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Xingtai Medical College', 'geoPoint': {'lat': 37.06217, 'lon': 114.49272}}, {'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Renmin Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Changzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': "The Second People's Hospital of Changzhou", 'geoPoint': {'lat': 31.77359, 'lon': 119.95401}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Nantong', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Affiliated Hospital of Nantong University', 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}, {'city': 'Wuxi', 'state': 'Jiangsu', 'country': 'China', 'facility': "Wuxi People's Hospital", 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}, {'city': 'Yangzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': "Northern Jiangsu People's Hospital", 'geoPoint': {'lat': 32.39722, 'lon': 119.43583}}, {'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': "Jilin Province People's Hospital", 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'The Second Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Dalian', 'state': 'Liaoning', 'country': 'China', 'facility': 'Dalina Municipal Central Hospital', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Dalian', 'state': 'Liaoning', 'country': 'China', 'facility': 'The First Hospital of Dalian Medical University', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Dalian', 'state': 'Liaoning', 'country': 'China', 'facility': 'The Second Hospital of Dalian Medical University', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai General Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Shanghai Tenth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Xinhua Hospital Affiliated to Shanghai Jiao Tong Universiity School of Medcine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'facility': 'The Second Hospital of Shanxi Medical University', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': "Tianjin People's Hospital", 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "Zhejiang Provincial People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Alebund Pharmaceuticals Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}