A Phase 2 Study to Evaluate the Safety and Efficacy of VS-505(AP301) to Treat Hyperphosphatemia in Hemodialysis Patients
1 other identifier
interventional
158
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2020
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2020
CompletedFirst Posted
Study publicly available on registry
September 16, 2020
CompletedStudy Start
First participant enrolled
October 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2022
CompletedOctober 18, 2022
October 1, 2022
1.7 years
August 31, 2020
October 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Serum phosphorus change from baseline to end of treatment
6 weeks
Secondary Outcomes (5)
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 Outcomes (2)
Serum ferritin change from baseline to end of treatment
6 weeks
Number of serious adverse events (SAEs)
6 weeks
Study Arms (5)
VS-505 500mg
EXPERIMENTALVS-505 500mg (two 250 mg capsules) oral administration three times a day with meal, daily total dosage 1500mg.
VS-505 750mg
EXPERIMENTALVS-505 750mg (one 750 mg capsule) oral administration three times a day with meal, daily total dosage 2250mg.
VS-505 1500mg
EXPERIMENTALVS-505 1500mg (two 750 mg capsules) oral administration three times a day with meal, daily total dosage 4500mg.
VS-505 2250mg
EXPERIMENTALVS-505 2250mg (three 750 mg capsules) oral administration three times a day with meal, daily total dosage 6750mg.
Sevelamer Carbonate 1600mg
ACTIVE COMPARATORSevelamer Carbonate 1600mg (two 800mg pills) oral administration three times a day with meal, daily total dosage 4800mg.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Peking University People's Hospital
Beijing, Beijing Municipality, China
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
Wuxi People's Hospital
Wuxi, Jiangsu, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
Jilin Province People's Hospital
Changchun, Jilin, China
The Second Hospital of Jilin University
Changchun, Jilin, 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
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong Universiity School of Medcine
Shanghai, Shanghai Municipality, China
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Related Publications (1)
Zhuang B, Gan L, Liu B, Yuan W, Shi M, Peng A, Wang L, Chen X, Liu T, Zhang S, Wang S, Gao Q, Wang B, Zheng H, Liu C, Luo Y, Ye H, Lin H, Li Y, He Q, Zheng F, Luo P, Long G, Lu W, Li K, Yang J, Liu YC, Zhang Z, Li X, Zhang W, Zuo L. Tolerability, safety and efficacy of a novel phosphate binder VS-505 (AP301): a Phase 2 dose-escalation and dose-ranging study in patients undergoing maintenance hemodialysis. Nephrol Dial Transplant. 2024 Sep 27;39(10):1649-1661. doi: 10.1093/ndt/gfae053.
PMID: 38453435DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2020
First Posted
September 16, 2020
Study Start
October 13, 2020
Primary Completion
June 30, 2022
Study Completion
October 15, 2022
Last Updated
October 18, 2022
Record last verified: 2022-10