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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04551300
Other study ID # APCKD001
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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