A Study to Evaluate Safety and Efficacy of AP-306 in Hyperphosphatemia Patients
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
1 other identifier
interventional
55
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2023
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2023
CompletedStudy Start
First participant enrolled
February 20, 2023
CompletedFirst Posted
Study publicly available on registry
March 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 14, 2023
CompletedJanuary 10, 2024
January 1, 2024
6 months
February 17, 2023
January 8, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate the efficacy of AP-306 assessed by serum phosphorus lowering
The change in serum phosphorus level from the baseline to the end of treatment
12 weeks
Other Outcomes (1)
To evaluate the overall safety of AP-306 assessed by incidence of treatment-emergent adverse events
15 weeks
Study Arms (2)
AP-306
EXPERIMENTALSevelamer Carbonate
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- On a stable hemodialysis regimen at a frequency of three times per week for at least 12 weeks prior to the screening visit
- Dialysis sufficiency SpKt/V ≥ 1.2 at the screening visit or any documented result within 12 weeks prior to the screening visit
- Serum phosphorus within the trial-required range
You may not qualify if:
- Pregnant or breastfeeding
- Any history of kidney transplant
- Any history of a parathyroid intervention
- Any clinically significant GI disorders within 4 weeks prior to the screening visit
- Hospitalization for cardiac or cerebrovascular disease within 24 weeks prior to the screening visit
- Hospitalization for cardiac or cerebrovascular disease within 24 weeks prior to the screening visit
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Li Wang, MD
Sichuan Provincial People's Hospital
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
February 17, 2023
First Posted
March 10, 2023
Study Start
February 20, 2023
Primary Completion
August 25, 2023
Study Completion
September 14, 2023
Last Updated
January 10, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share