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

Alebund

Status and phase: Completed; Phase 2

Conditions: Chronic Kidney Diseases; Hyperphosphatemia

Treatments: Drug: AP-306; Drug: Sevelamer Carbonate

Study type: Interventional

Funder types: Industry

Identifiers

NCT05764590

AP306-HP-01

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

AP-306

Experimental group

Treatment:

Drug: AP-306

Sevelamer Carbonate

Active Comparator group

Treatment:

Drug: Sevelamer Carbonate