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
Overview
- Phase
- Phase 2
- Intervention
- VS-505
- Conditions
- Hyperphosphatemia
- Sponsor
- Shanghai Alebund Pharmaceuticals Limited
- Enrollment
- 158
- Locations
- 23
- Primary Endpoint
- Serum phosphorus change from baseline to end of treatment
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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.
Arms & Interventions
VS-505 500mg
VS-505 500mg (two 250 mg capsules) oral administration three times a day with meal, daily total dosage 1500mg.
Intervention: VS-505
VS-505 750mg
VS-505 750mg (one 750 mg capsule) oral administration three times a day with meal, daily total dosage 2250mg.
Intervention: VS-505
VS-505 1500mg
VS-505 1500mg (two 750 mg capsules) oral administration three times a day with meal, daily total dosage 4500mg.
Intervention: VS-505
VS-505 2250mg
VS-505 2250mg (three 750 mg capsules) oral administration three times a day with meal, daily total dosage 6750mg.
Intervention: VS-505
Sevelamer Carbonate 1600mg
Sevelamer Carbonate 1600mg (two 800mg pills) oral administration three times a day with meal, daily total dosage 4800mg.
Intervention: Sevelamer Carbonate
Outcomes
Primary Outcomes
Serum phosphorus change from baseline to end of treatment
Time Frame: 6 weeks
Secondary Outcomes
- 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)