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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
158
4 dosages of experimental drug
Active Comparator
Peking University People's Hospital
Beijing, Beijing Municipality, China
Serum phosphorus change from baseline to end of treatment
Time frame: 6 weeks
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)
Time frame: 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
Time frame: 6 weeks
Serum calcium change from baseline to end of treatment
Time frame: 6 weeks
Serum Ca×P change from baseline to end of treatment
Time frame: 6 weeks
Serum iPTH change from baseline to end of treatment
Time frame: 6 weeks
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Peking University Third Hospital
Beijing, Beijing Municipality, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Xingtai Medical College
Xingtai, Hebei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
The Second People's Hospital of Changzhou
Changzhou, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
...and 13 more locations