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

Sponsor
Shanghai Alebund Pharmaceuticals Limited (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04551300
Collaborator
(none)
158
23
5
26.6
6.9
0.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
158 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
4 different dosages of VS-505 in Comparison with Sevelamer Carbonate4 different dosages of VS-505 in Comparison with Sevelamer Carbonate
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 13, 2020
Actual Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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.

Drug: VS-505
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.

Drug: VS-505
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.

Drug: VS-505
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.

Drug: VS-505
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.

Drug: Sevelamer Carbonate
Active Comparator
Other Names:
  • Renvela
  • Outcome Measures

    Primary Outcome Measures

    1. Serum phosphorus change from baseline to end of treatment [6 weeks]

    Secondary Outcome Measures

    1. 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]

    2. 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]

    3. Serum calcium change from baseline to end of treatment [6 weeks]

    4. Serum Ca×P change from baseline to end of treatment [6 weeks]

    5. Serum iPTH change from baseline to end of treatment [6 weeks]

    Other Outcome Measures

    1. Serum ferritin change from baseline to end of treatment [6 weeks]

    2. Number of serious adverse events (SAEs) [6 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University People's Hospital Beijing Beijing China
    2 Peking University Third Hospital Beijing Beijing China
    3 Zhongshan Hospital Xiamen University Xiamen Fujian China
    4 Affiliated Hospital of Guilin Medical University Guilin Guangxi China
    5 The Third Hospital of Hebei Medical University Shijia Zhuang Hebei China
    6 The Second Affiliated Hospital of Xingtai Medical College Xingtai Hebei China
    7 Renmin Hospital of Wuhan University Wuhan Hubei China
    8 The Second People's Hospital of Changzhou Changzhou Jiangsu China
    9 The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu China
    10 Affiliated Hospital of Nantong University Nantong Jiangsu China
    11 Wuxi People's Hospital Wuxi Jiangsu China
    12 Northern Jiangsu People's Hospital Yangzhou Jiangsu China
    13 Jilin Province People's Hospital Changchun Jilin China
    14 The Second Hospital of Jilin University Changchun Jilin China
    15 Dalina Municipal Central Hospital Dalian Liaoning China
    16 The First Hospital of Dalian Medical University Dalian Liaoning China
    17 The Second Hospital of Dalian Medical University Dalian Liaoning China
    18 Shanghai General Hospital Shanghai Shanghai China
    19 Shanghai Tenth People's Hospital Shanghai Shanghai China
    20 Xinhua Hospital Affiliated to Shanghai Jiao Tong Universiity School of Medcine Shanghai Shanghai China
    21 The Second Hospital of Shanxi Medical University Taiyuan Shanxi China
    22 Tianjin People's Hospital Tianjin Tianjin China
    23 Zhejiang Provincial People's Hospital Hangzhou Zhejiang China

    Sponsors and Collaborators

    • Shanghai Alebund Pharmaceuticals Limited

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanghai Alebund Pharmaceuticals Limited
    ClinicalTrials.gov Identifier:
    NCT04551300
    Other Study ID Numbers:
    • APCKD001
    First Posted:
    Sep 16, 2020
    Last Update Posted:
    Jul 12, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 12, 2022