Clinical trial NCT04551300: A Phase 2 Study to Evaluate the Safety and Efficacy of VS-505(AP301) to Treat Hyperphosphatemia in Hemodialysis Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperphosphatemia
Lead sponsor: Shanghai Alebund Pharmaceuticals Limited
Sponsor class: INDUSTRY
First posted: 2020-09-16
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4 different dosages of VS-505 in Comparison with Sevelamer Carbonate
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Serum phosphorus change from baseline to end of treatment
timeFrame: 6 weeks
Secondary outcomes:
measure: 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）
timeFrame: 6 weeks
measure: 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
timeFrame: 6 weeks
measure: Serum calcium change from baseline to end of treatment
timeFrame: 6 weeks
measure: Serum Ca×P change from baseline to end of treatment
timeFrame: 6 weeks
measure: Serum iPTH change from baseline to end of treatment
timeFrame: 6 weeks
Other outcomes:
measure: Serum ferritin change from baseline to end of treatment
timeFrame: 6 weeks
measure: Number of serious adverse events (SAEs)
timeFrame: 6 weeks
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University
state: Fujian
city: Guilin
country: China
facility: Affiliated Hospital of Guilin Medical University
state: Guangxi
city: Shijia Zhuang
country: China
facility: The Third Hospital of Hebei Medical University
state: Hebei
city: Xingtai
country: China
facility: The Second Affiliated Hospital of Xingtai Medical College
state: Hebei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Changzhou
country: China
facility: The Second People's Hospital of Changzhou
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
city: Changchun
country: China
facility: Jilin Province People's Hospital
state: Jilin
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: Dalina Municipal Central Hospital
state: Liaoning
city: Dalian
country: China
facility: The First Hospital of Dalian Medical University
state: Liaoning
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
state: Liaoning
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong Universiity School of Medcine
state: Shanghai
city: Taiyuan
country: China
facility: The Second Hospital of Shanxi Medical University
state: Shanxi
city: Tianjin
country: China
facility: Tianjin People's Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
Study officials:
References: