Back to resultsA Phase 2 Study to Evaluate the Safety and Efficacy of VS-505(AP301) to Treat Hyperphosphatemia in Hemodialysis Patients
Primary Purpose
Hyperphosphatemia
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
VS-505
Sevelamer Carbonate
Sponsored by
About this trial
This is an interventional treatment trial for Hyperphosphatemia
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.
Sites / Locations
- Peking University People's Hospital
- Peking University Third Hospital
- Zhongshan Hospital Xiamen University
- Affiliated Hospital of Guilin Medical University
- The Third Hospital of Hebei Medical University
- The Second Affiliated Hospital of Xingtai Medical College
- Renmin Hospital of Wuhan University
- The Second People's Hospital of Changzhou
- The Second Affiliated Hospital of Nanjing Medical University
- Affiliated Hospital of Nantong University
- Wuxi People's Hospital
- Northern Jiangsu People's Hospital
- Jilin Province People's Hospital
- The Second Hospital of Jilin University
- Dalina Municipal Central Hospital
- The First Hospital of Dalian Medical University
- The Second Hospital of Dalian Medical University
- Shanghai General Hospital
- Shanghai Tenth People's Hospital
- Xinhua Hospital Affiliated to Shanghai Jiao Tong Universiity School of Medcine
- The Second Hospital of Shanxi Medical University
- Tianjin People's Hospital
- Zhejiang Provincial People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Arm Label
VS-505 500mg
VS-505 750mg
VS-505 1500mg
VS-505 2250mg
Sevelamer Carbonate 1600mg
Arm Description
VS-505 500mg (two 250 mg capsules) oral administration three times a day with meal, daily total dosage 1500mg.
VS-505 750mg (one 750 mg capsule) oral administration three times a day with meal, daily total dosage 2250mg.
VS-505 1500mg (two 750 mg capsules) oral administration three times a day with meal, daily total dosage 4500mg.
VS-505 2250mg (three 750 mg capsules) oral administration three times a day with meal, daily total dosage 6750mg.
Sevelamer Carbonate 1600mg (two 800mg pills) oral administration three times a day with meal, daily total dosage 4800mg.
Outcomes
Primary Outcome Measures
Serum phosphorus change from baseline to end of treatment
Secondary Outcome Measures
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）
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
Serum calcium change from baseline to end of treatment
Serum Ca×P change from baseline to end of treatment
Serum iPTH change from baseline to end of treatment
Full Information
NCT ID
NCT04551300
First Posted
August 31, 2020
Last Updated
October 17, 2022
Sponsor
Shanghai Alebund Pharmaceuticals Limited
1. Study Identification
Unique Protocol Identification Number
NCT04551300
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 13, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
October 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Alebund Pharmaceuticals Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphosphatemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
4 different dosages of VS-505 in Comparison with Sevelamer Carbonate
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VS-505 500mg
Arm Type
Experimental
Arm Description
VS-505 500mg (two 250 mg capsules) oral administration three times a day with meal, daily total dosage 1500mg.
Arm Title
VS-505 750mg
Arm Type
Experimental
Arm Description
VS-505 750mg (one 750 mg capsule) oral administration three times a day with meal, daily total dosage 2250mg.
Arm Title
VS-505 1500mg
Arm Type
Experimental
Arm Description
VS-505 1500mg (two 750 mg capsules) oral administration three times a day with meal, daily total dosage 4500mg.
Arm Title
VS-505 2250mg
Arm Type
Experimental
Arm Description
VS-505 2250mg (three 750 mg capsules) oral administration three times a day with meal, daily total dosage 6750mg.
Arm Title
Sevelamer Carbonate 1600mg
Arm Type
Active Comparator
Arm Description
Sevelamer Carbonate 1600mg (two 800mg pills) oral administration three times a day with meal, daily total dosage 4800mg.
Intervention Type
Drug
Intervention Name(s)
VS-505
Intervention Description
4 dosages of experimental drug
Intervention Type
Drug
Intervention Name(s)
Sevelamer Carbonate
Other Intervention Name(s)
Renvela
Intervention Description
Active Comparator
Primary Outcome Measure Information:
Title
Serum phosphorus change from baseline to end of treatment
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Serum calcium change from baseline to end of treatment
Time Frame
6 weeks
Title
Serum Ca×P change from baseline to end of treatment
Time Frame
6 weeks
Title
Serum iPTH change from baseline to end of treatment
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Serum ferritin change from baseline to end of treatment
Time Frame
6 weeks
Title
Number of serious adverse events (SAEs)
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Zhongshan Hospital Xiamen University
City
Xiamen
State/Province
Fujian
Country
China
Facility Name
Affiliated Hospital of Guilin Medical University
City
Guilin
State/Province
Guangxi
Country
China
Facility Name
The Third Hospital of Hebei Medical University
City
Shijia Zhuang
State/Province
Hebei
Country
China
Facility Name
The Second Affiliated Hospital of Xingtai Medical College
City
Xingtai
State/Province
Hebei
Country
China
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
The Second People's Hospital of Changzhou
City
Changzhou
State/Province
Jiangsu
Country
China
Facility Name
The Second Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Affiliated Hospital of Nantong University
City
Nantong
State/Province
Jiangsu
Country
China
Facility Name
Wuxi People's Hospital
City
Wuxi
State/Province
Jiangsu
Country
China
Facility Name
Northern Jiangsu People's Hospital
City
Yangzhou
State/Province
Jiangsu
Country
China
Facility Name
Jilin Province People's Hospital
City
Changchun
State/Province
Jilin
Country
China
Facility Name
The Second Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Dalina Municipal Central Hospital
City
Dalian
State/Province
Liaoning
Country
China
Facility Name
The First Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China
Facility Name
The Second Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China
Facility Name
Shanghai General Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Tenth People's Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Xinhua Hospital Affiliated to Shanghai Jiao Tong Universiity School of Medcine
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
The Second Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
Tianjin People's Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Phase 2 Study to Evaluate the Safety and Efficacy of VS-505(AP301) to Treat Hyperphosphatemia in Hemodialysis Patients
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