Clinical Trial Details
| Trial ID: | L1746 |
| Source ID: | NCT04551300 |
| Associated Drug: | Vs-505 |
| Title: | A Phase 2 Study to Evaluate the Safety and Efficacy of VS-505(AP301) to Treat Hyperphosphatemia in Hemodialysis Patients |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Hyperphosphatemia |
| Interventions: | DRUG: VS-505|DRUG: Sevelamer Carbonate |
| Outcome Measures: | Primary: Serum phosphorus change from baseline to end of treatment, 6 weeks | Secondary: 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, 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 | Other: Serum ferritin change from baseline to end of treatment, 6 weeks|Number of serious adverse events (SAEs), 6 weeks |
| Sponsor/Collaborators: | Sponsor: Shanghai Alebund Pharmaceuticals Limited |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 158 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2020-10-13 |
| Completion Date: | 2022-10-15 |
| Results First Posted: | |
| Last Update Posted: | 2022-10-18 |
| Locations: | Peking University People's Hospital, Beijing, Beijing, China|Peking University Third Hospital, Beijing, Beijing, China|Zhongshan Hospital Xiamen University, Xiamen, Fujian, China|Affiliated Hospital of Guilin Medical University, Guilin, Guangxi, China|The Third Hospital of Hebei Medical University, Shijia Zhuang, 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, China|Shanghai Tenth People's Hospital, Shanghai, Shanghai, China|Xinhua Hospital Affiliated to Shanghai Jiao Tong Universiity School of Medcine, Shanghai, Shanghai, China|The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China|Tianjin People's Hospital, Tianjin, Tianjin, China|Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China |
| URL: | https://clinicaltrials.gov/show/NCT04551300 |
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