Hyperphosphatemia Clinical Trial
Official title:
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
Verified date | October 2022 |
Source | Shanghai Alebund Pharmaceuticals Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 158 |
Est. completion date | October 15, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults with end stage renal disease who are receiving a stable hemodialysis regimen (3 times per week) with sufficient dialysis adequacy; - 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. Exclusion Criteria: - 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; - 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); - Serum calcium level is <8 mg/dL or >11 mg/dL at the screening; - Serum immunoreactive parathyroid hormone (iPTH)>1000 pg/mL at the screening; - History of hemochromatosis or serum ferritin value =1000 µg/L at screening; - Current clinically significant gastrointestinal (GI) disorder, or history of intestine obstruction, gastrectomy or duodenectomy, or GI tract surgery within 12 weeks prior to screening; - Poorly controlled hypertension, cardiovascular disorders, and history of cerebrovascular disease or cardiovascular disease event within 24 weeks (6 months) prior to screening. |
Country | Name | City | State |
---|---|---|---|
China | Peking University People's Hospital | Beijing | Beijing |
China | Peking University Third Hospital | Beijing | Beijing |
China | Jilin Province People's Hospital | Changchun | Jilin |
China | The Second Hospital of Jilin University | Changchun | Jilin |
China | The Second People's Hospital of Changzhou | Changzhou | Jiangsu |
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 | Affiliated Hospital of Guilin Medical University | Guilin | Guangxi |
China | Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang |
China | The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu |
China | Affiliated Hospital of Nantong University | Nantong | Jiangsu |
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 Third Hospital of Hebei Medical University | Shijia Zhuang | Hebei |
China | The Second Hospital of Shanxi Medical University | Taiyuan | Shanxi |
China | Tianjin People's Hospital | Tianjin | Tianjin |
China | Renmin Hospital of Wuhan University | Wuhan | Hubei |
China | Wuxi People's Hospital | Wuxi | Jiangsu |
China | Zhongshan Hospital Xiamen University | Xiamen | Fujian |
China | The Second Affiliated Hospital of Xingtai Medical College | Xingtai | Hebei |
China | Northern Jiangsu People's Hospital | Yangzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Shanghai Alebund Pharmaceuticals Limited |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Serum ferritin change from baseline to end of treatment | 6 weeks | ||
Other | Number of serious adverse events (SAEs) | 6 weeks | ||
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 | ||
Secondary | 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 | ||
Secondary | Serum calcium change from baseline to end of treatment | 6 weeks | ||
Secondary | Serum Ca×P change from baseline to end of treatment | 6 weeks | ||
Secondary | Serum iPTH change from baseline to end of treatment | 6 weeks |
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