Back to resultsA Study to Evaluate Safety and Efficacy of AP-306 in Hyperphosphatemia Patients
Primary Purpose
Chronic Kidney Diseases, Hyperphosphatemia
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
AP-306
Sevelamer Carbonate
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Diseases
Eligibility Criteria
Important Inclusion Criteria: 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 Important Exclusion Criteria: 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
Sites / Locations
- Sichuan Provincial People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
AP-306
Sevelamer Carbonate
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05764590
First Posted
February 17, 2023
Last Updated
March 9, 2023
Sponsor
Alebund Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT05764590
Brief Title
A Study to Evaluate Safety and Efficacy of AP-306 in Hyperphosphatemia Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alebund Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Hyperphosphatemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AP-306
Arm Type
Experimental
Arm Title
Sevelamer Carbonate
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
AP-306
Intervention Description
A blood phosphorus lowering drug with a novel mechanism
Intervention Type
Drug
Intervention Name(s)
Sevelamer Carbonate
Intervention Description
A phosphate binder
Primary Outcome Measure Information:
Title
To evaluate the efficacy of AP-306 assessed by serum phosphorus lowering
Description
The change in serum phosphorus level from the baseline to the end of treatment
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
To evaluate the overall safety of AP-306 assessed by incidence of treatment-emergent adverse events
Description
All adverse events occurred after the study treatment initiation will be collected and their nature, frequency, and severity will be assessed.
Time Frame
15 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Important Inclusion Criteria:
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
Important Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weifeng Zhang, MD
Phone
+8618602184576
Email
weifeng.zhang@alebund.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Wang, MD
Organizational Affiliation
Sichuan Provincial People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sichuan Provincial People's Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Wang, MD
Email
scwangli@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate Safety and Efficacy of AP-306 in Hyperphosphatemia Patients
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