A Phase 2 Study to Evaluate the Safety and Efficacy of VS-505(AP301) to Treat Hyperphosphatemia in Hemodialysis Patients

Hyperphosphatemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04551300
• Other study ID #: APCKD001
• Status: Completed
• Phase: Phase 2
• Start date: October 13, 2020
• Est. completion date: October 15, 2022

Study information

• Verified date: October 2022
• Source: Shanghai Alebund Pharmaceuticals Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: October 15, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperphosphatemia

Intervention

Drug:
• VS-505
4 dosages of experimental drug
• Sevelamer Carbonate
Active Comparator

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	Jilin Province People's Hospital	Changchun	Jilin
China	The Second Hospital of Jilin University	Changchun	Jilin
China	The Second People's Hospital of Changzhou	Changzhou	Jiangsu
China	Dalina Municipal Central Hospital	Dalian	Liaoning
China	The First Hospital of Dalian Medical University	Dalian	Liaoning
China	The Second Hospital of Dalian Medical University	Dalian	Liaoning
China	Affiliated Hospital of Guilin Medical University	Guilin	Guangxi
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Affiliated Hospital of Nantong University	Nantong	Jiangsu
China	Shanghai General Hospital	Shanghai	Shanghai
China	Shanghai Tenth People's Hospital	Shanghai	Shanghai
China	Xinhua Hospital Affiliated to Shanghai Jiao Tong Universiity School of Medcine	Shanghai	Shanghai
China	The Third Hospital of Hebei Medical University	Shijia Zhuang	Hebei
China	The Second Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Tianjin People's Hospital	Tianjin	Tianjin
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	Wuxi People's Hospital	Wuxi	Jiangsu
China	Zhongshan Hospital Xiamen University	Xiamen	Fujian
China	The Second Affiliated Hospital of Xingtai Medical College	Xingtai	Hebei
China	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Alebund Pharmaceuticals Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum ferritin change from baseline to end of treatment		6 weeks
Other	Number of serious adverse events (SAEs)		6 weeks
Primary	Serum phosphorus change from baseline to end of treatment		6 weeks
Secondary	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
Secondary	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
Secondary	Serum calcium change from baseline to end of treatment		6 weeks
Secondary	Serum Ca×P change from baseline to end of treatment		6 weeks
Secondary	Serum iPTH change from baseline to end of treatment		6 weeks