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A Study to Evaluate Safety and Efficacy of AP-306 in Hyperphosphatemia Patients

Sponsor
Alebund Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05764590
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
10.3
Anticipated Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to learn about the following questions in the patients receiving maintenance hemodialysis with elevated blood phosphorus:

  • How much effect AP-306 has assessed by blood phosphorus lowering;

  • How safe and tolerable AP-306 is.

Participants will receive either following treatments:

  • AP-306, and

  • Sevelamer carbonate.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Open-Label, Active-Controlled, Multicenter Study to Evaluate the Safety and Serum Phosphorus Lowering Effect of AP-306 in Chronic Kidney Disease Patients Receiving Maintenance Hemodialysis With Hyperphosphatemia
Actual Study Start Date :
Feb 20, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: AP-306

Drug: AP-306
A blood phosphorus lowering drug with a novel mechanism
Active Comparator: Sevelamer Carbonate

Drug: Sevelamer Carbonate
A phosphate binder

Outcome Measures

Primary Outcome Measures

  1. To evaluate the efficacy of AP-306 assessed by serum phosphorus lowering [12 weeks]

    The change in serum phosphorus level from the baseline to the end of treatment

Other Outcome Measures

  1. To evaluate the overall safety of AP-306 assessed by incidence of treatment-emergent adverse events [15 weeks]

    All adverse events occurred after the study treatment initiation will be collected and their nature, frequency, and severity will be assessed.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Important Inclusion Criteria:

  1. On a stable hemodialysis regimen at a frequency of three times per week for at least 12 weeks prior to the screening visit

  2. Dialysis sufficiency SpKt/V ≥ 1.2 at the screening visit or any documented result within 12 weeks prior to the screening visit

  3. Serum phosphorus within the trial-required range

Important Exclusion Criteria:

  1. Pregnant or breastfeeding

  2. Any history of kidney transplant

  3. Any history of a parathyroid intervention

  4. Any clinically significant GI disorders within 4 weeks prior to the screening visit

  5. Hospitalization for cardiac or cerebrovascular disease within 24 weeks prior to the screening visit

  6. Hospitalization for cardiac or cerebrovascular disease within 24 weeks prior to the screening visit

  7. Documented history of hypersensitivity or allergic reactions to any of the excipients used by AP-306, or history of hypersensitivity or allergic reactions or intolerant to sevelamer carbonate

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sichuan Provincial People's Hospital Chengdu Sichuan China 610072

Sponsors and Collaborators

  • Alebund Pharmaceuticals

Investigators

  • Principal Investigator: Li Wang, MD, Sichuan Provincial People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alebund Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT05764590
Other Study ID Numbers:
  • AP306-HP-01
First Posted:
Mar 10, 2023
Last Update Posted:
Mar 10, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Hyperphosphatemia
Sevelamer

Study Results

No Results Posted as of Mar 10, 2023