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

October 17, 2022 updated by: Shanghai Alebund Pharmaceuticals Limited

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China
        • Peking University Third Hospital
      • Beijing, Beijing, China
        • Peking University People's Hospital
    • Fujian
      • Xiamen, Fujian, China
        • Zhongshan Hospital Xiamen University
    • Guangxi
      • Guilin, Guangxi, China
        • Affiliated Hospital of Guilin Medical University
    • Hebei
      • Shijia Zhuang, Hebei, China
        • The Third Hospital of Hebei Medical University
      • Xingtai, Hebei, China
        • The Second Affiliated Hospital of Xingtai Medical College
    • Hubei
      • Wuhan, Hubei, China
        • Renmin Hospital of Wuhan University
    • Jiangsu
      • Changzhou, Jiangsu, China
        • The Second People's Hospital of Changzhou
      • Nanjing, Jiangsu, China
        • The Second Affiliated Hospital of Nanjing Medical University
      • Nantong, Jiangsu, China
        • Affiliated Hospital of Nantong University
      • Wuxi, Jiangsu, China
        • Wuxi People's Hospital
      • Yangzhou, Jiangsu, China
        • Northern Jiangsu People's Hospital
    • Jilin
      • Changchun, Jilin, China
        • The Second Hospital of Jilin University
      • Changchun, Jilin, China
        • Jilin Province People's Hospital
    • Liaoning
      • Dalian, Liaoning, 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
    • Shanghai
      • Shanghai, Shanghai, 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
    • Shanxi
      • Taiyuan, Shanxi, China
        • The Second Hospital of Shanxi Medical University
    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin People's Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Zhejiang Provincial People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VS-505 500mg
VS-505 500mg (two 250 mg capsules) oral administration three times a day with meal, daily total dosage 1500mg.
4 dosages of experimental drug
Experimental: VS-505 750mg
VS-505 750mg (one 750 mg capsule) oral administration three times a day with meal, daily total dosage 2250mg.
4 dosages of experimental drug
Experimental: VS-505 1500mg
VS-505 1500mg (two 750 mg capsules) oral administration three times a day with meal, daily total dosage 4500mg.
4 dosages of experimental drug
Experimental: VS-505 2250mg
VS-505 2250mg (three 750 mg capsules) oral administration three times a day with meal, daily total dosage 6750mg.
4 dosages of experimental drug
Active Comparator: Sevelamer Carbonate 1600mg
Sevelamer Carbonate 1600mg (two 800mg pills) oral administration three times a day with meal, daily total dosage 4800mg.
Active Comparator
Other Names:
  • Renvela

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum phosphorus change from baseline to end of treatment
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: 6 weeks
6 weeks
Serum calcium change from baseline to end of treatment
Time Frame: 6 weeks
6 weeks
Serum Ca×P change from baseline to end of treatment
Time Frame: 6 weeks
6 weeks
Serum iPTH change from baseline to end of treatment
Time Frame: 6 weeks
6 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Serum ferritin change from baseline to end of treatment
Time Frame: 6 weeks
6 weeks
Number of serious adverse events (SAEs)
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2020

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

October 15, 2022

Study Registration Dates

First Submitted

August 31, 2020

First Submitted That Met QC Criteria

September 10, 2020

First Posted (Actual)

September 16, 2020

Study Record Updates

Last Update Posted (Actual)

October 18, 2022

Last Update Submitted That Met QC Criteria

October 17, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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