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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VS-505 500mg | Experimental | VS-505 500mg (two 250 mg capsules) oral administration three times a day with meal, daily total dosage 1500mg. |
|
| VS-505 750mg | Experimental | VS-505 750mg (one 750 mg capsule) oral administration three times a day with meal, daily total dosage 2250mg. |
|
| VS-505 1500mg | Experimental | VS-505 1500mg (two 750 mg capsules) oral administration three times a day with meal, daily total dosage 4500mg. |
|
| VS-505 2250mg | Experimental | VS-505 2250mg (three 750 mg capsules) oral administration three times a day with meal, daily total dosage 6750mg. |
|
| Sevelamer Carbonate 1600mg | Active Comparator | Sevelamer Carbonate 1600mg (two 800mg pills) oral administration three times a day with meal, daily total dosage 4800mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VS-505 | Drug | 4 dosages of experimental drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum phosphorus change from baseline to end of treatment | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 weeks | |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum ferritin change from baseline to end of treatment | 6 weeks | |
| Number of serious adverse events (SAEs) | 6 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | China | |||
| Peking University Third Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38453435 | Derived | 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. |
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4 different dosages of VS-505 in Comparison with Sevelamer Carbonate
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| Sevelamer Carbonate | Drug | Active Comparator |
|
|
| 6 weeks |
| Serum calcium change from baseline to end of treatment | 6 weeks |
| Serum Ca×P change from baseline to end of treatment | 6 weeks |
| Serum iPTH change from baseline to end of treatment | 6 weeks |
| Beijing |
| Beijing Municipality |
| China |
| Zhongshan Hospital Xiamen University | Xiamen | Fujian | China |
| Affiliated Hospital of Guilin Medical University | Guilin | Guangxi | China |
| The Third Hospital of Hebei Medical University | Shijiazhuang | Hebei | China |
| The Second Affiliated Hospital of Xingtai Medical College | Xingtai | Hebei | China |
| Renmin Hospital of Wuhan University | Wuhan | Hubei | China |
| The Second People's Hospital of Changzhou | Changzhou | Jiangsu | China |
| The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | China |
| Affiliated Hospital of Nantong University | Nantong | Jiangsu | China |
| Wuxi People's Hospital | Wuxi | Jiangsu | China |
| Northern Jiangsu People's Hospital | Yangzhou | Jiangsu | China |
| Jilin Province People's Hospital | Changchun | Jilin | China |
| The Second Hospital of Jilin University | Changchun | Jilin | China |
| Dalina Municipal Central Hospital | Dalian | Liaoning | China |
| The First Hospital of Dalian Medical University | Dalian | Liaoning | China |
| The Second Hospital of Dalian Medical University | Dalian | Liaoning | China |
| Shanghai General Hospital | Shanghai | Shanghai Municipality | China |
| Shanghai Tenth People's Hospital | Shanghai | Shanghai Municipality | China |
| Xinhua Hospital Affiliated to Shanghai Jiao Tong Universiity School of Medcine | Shanghai | Shanghai Municipality | China |
| The Second Hospital of Shanxi Medical University | Taiyuan | Shanxi | China |
| Tianjin People's Hospital | Tianjin | Tianjin Municipality | China |
| Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069603 | Sevelamer |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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