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

Phase 2

Completed

• Conditions: Chronic Kidney Diseases; Hyperphosphatemia
• Interventions: Drug: AP-306; Drug: Sevelamer Carbonate

• Registration Number: NCT05764590
• Lead Sponsor: Alebund Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-17
• Study Start: 2023-02-20
• Study First Submitted QC: 2023-03-09
• Study First Posted: 2023-03-10
• Primary Completion: 2023-08-25
• Study Completion: 2023-09-14
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AP-306	AP-306	-
Sevelamer Carbonate	Sevelamer Carbonate	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China