A Phase 2 Study to Evaluate the Safety and Efficacy of VS-505(AP301) to Treat Hyperphosphatemia in Hemodialysis Patients
- Registration Number
- NCT04551300
- Lead Sponsor
- Shanghai Alebund Pharmaceuticals Limited
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 158
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VS-505 2250mg VS-505 VS-505 2250mg (three 750 mg capsules) oral administration three times a day with meal, daily total dosage 6750mg. VS-505 500mg VS-505 VS-505 500mg (two 250 mg capsules) oral administration three times a day with meal, daily total dosage 1500mg. VS-505 750mg VS-505 VS-505 750mg (one 750 mg capsule) oral administration three times a day with meal, daily total dosage 2250mg. VS-505 1500mg VS-505 VS-505 1500mg (two 750 mg capsules) oral administration three times a day with meal, daily total dosage 4500mg. Sevelamer Carbonate 1600mg Sevelamer Carbonate Sevelamer Carbonate 1600mg (two 800mg pills) oral administration three times a day with meal, daily total dosage 4800mg.
- Primary Outcome Measures
Name Time Method Serum phosphorus change from baseline to end of treatment 6 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (23)
Wuxi People's Hospital
🇨🇳Wuxi, Jiangsu, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Renmin Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Zhongshan Hospital Xiamen University
🇨🇳Xiamen, Fujian, China
The Third Hospital of Hebei Medical University
🇨🇳Shijia Zhuang, Hebei, China
The Second Affiliated Hospital of Xingtai Medical College
🇨🇳Xingtai, Hebei, China
The Second People's Hospital of Changzhou
🇨🇳Changzhou, Jiangsu, China
Jilin Province People's Hospital
🇨🇳Changchun, Jilin, China
The First 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
Affiliated Hospital of Guilin Medical University
🇨🇳Guilin, Guangxi, China
Affiliated Hospital of Nantong University
🇨🇳Nantong, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Northern Jiangsu People's Hospital
🇨🇳Yangzhou, Jiangsu, China
Dalina Municipal Central Hospital
🇨🇳Dalian, Liaoning, China
The Second Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The Second Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Tianjin People's Hospital
🇨🇳Tianjin, Tianjin, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China