A Phase 2 Study to Evaluate the Safety and Efficacy of VS-505(AP301) to Treat Hyperphosphatemia in Hemodialysis Patients
Hyperphosphatemia
About this trial
This is an interventional treatment trial for Hyperphosphatemia
Eligibility Criteria
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.
Sites / Locations
- Peking University People's Hospital
- Peking University Third Hospital
- Zhongshan Hospital Xiamen University
- Affiliated Hospital of Guilin Medical University
- The Third Hospital of Hebei Medical University
- The Second Affiliated Hospital of Xingtai Medical College
- Renmin Hospital of Wuhan University
- The Second People's Hospital of Changzhou
- The Second Affiliated Hospital of Nanjing Medical University
- Affiliated Hospital of Nantong University
- Wuxi People's Hospital
- Northern Jiangsu People's Hospital
- Jilin Province People's Hospital
- The Second Hospital of Jilin University
- Dalina Municipal Central Hospital
- The First Hospital of Dalian Medical University
- The Second Hospital of Dalian Medical University
- Shanghai General Hospital
- Shanghai Tenth People's Hospital
- Xinhua Hospital Affiliated to Shanghai Jiao Tong Universiity School of Medcine
- The Second Hospital of Shanxi Medical University
- Tianjin People's Hospital
- Zhejiang Provincial People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Active Comparator
VS-505 500mg
VS-505 750mg
VS-505 1500mg
VS-505 2250mg
Sevelamer Carbonate 1600mg
VS-505 500mg (two 250 mg capsules) oral administration three times a day with meal, daily total dosage 1500mg.
VS-505 750mg (one 750 mg capsule) oral administration three times a day with meal, daily total dosage 2250mg.
VS-505 1500mg (two 750 mg capsules) oral administration three times a day with meal, daily total dosage 4500mg.
VS-505 2250mg (three 750 mg capsules) oral administration three times a day with meal, daily total dosage 6750mg.
Sevelamer Carbonate 1600mg (two 800mg pills) oral administration three times a day with meal, daily total dosage 4800mg.