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

Chronic Kidney Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05764590
• Other study ID #: AP306-HP-01
• Status: Completed
• Phase: Phase 2
• Start date: February 20, 2023
• Est. completion date: September 14, 2023

Study information

• Verified date: January 2024
• Source: Alebund Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 14, 2023
• Est. primary completion date: August 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Hyperphosphatemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• AP-306
A blood phosphorus lowering drug with a novel mechanism
• Sevelamer Carbonate
A phosphate binder

Locations

Country	Name	City	State
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Alebund Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To evaluate the overall safety of AP-306 assessed by incidence of treatment-emergent adverse events	All adverse events occurred after the study treatment initiation will be collected and their nature, frequency, and severity will be assessed.	15 weeks
Primary	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