Hyperphosphatemia
Conditions
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.
Interventions
DRUGVS-505
4 dosages of experimental drug
DRUGSevelamer Carbonate
Active Comparator
Sponsors
Shanghai Alebund Pharmaceuticals Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
4 different dosages of VS-505 in Comparison with Sevelamer Carbonate
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum phosphorus change from baseline to end of treatment | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Serum ferritin change from baseline to end of treatment | 6 weeks |
| Number of serious adverse events (SAEs) | 6 weeks |
Countries
China
Outcome results
None listed