AP301 for High Phosphate Levels

Recruiting at 6 trial locations

Overseen By Bobby Zang

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Alebund Pharmaceuticals

Must be taking: Phosphate binders

Disqualifiers: Kidney transplant, Parathyroid intervention, GI disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

264 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if AP301 could work in the patients receiving maintenance dialysis with elevated blood phosphate. The main questions it aims to answer are: * Does AP301 lower blood phosphate levels? * Does AP301 works on serum calcium level, calcium times phosphate level, and intact parathyroid hormone level? * What discomfort or medical problem do the patients have when taking AP301? * Does AP301 improve quality of life in Chinese patients? The researchers will compare AP301 to an ineffective comparator (a look-alike substance that contains low dose AP301) to see if AP301 works to treat elevated blood phosphate. In the study, the patients will experience the following stages in a chronicle order: * Stop all using blood phosphate-lowering drugs, * Take AP301 or the comparator three times a day for 8 weeks, * Take AP301 three times a day for 24 weeks, and * Take AP301 or the comparator three times a day for 3 weeks. In the first 32 weeks, the dose of AP301 will be adjusted upwards or downwards based on the patient's blood phosphate level and the study doctor's judgment. If the participant has a blood phosphate level above or below a certain level, they may receive additional treatment to lower the blood phosphate level.

Eligibility Criteria

This trial is for adults on dialysis for at least 3 months with high blood phosphate levels, specifically between 6.0 and 10.0 mg/dL after stopping other phosphate-lowering drugs. They must have signed consent forms and meet specific dialysis efficiency criteria (spKt/V ≥ 1.2 for hemodialysis or total Kt/V ≥ 1.7/week for peritoneal dialysis).

Inclusion Criteria

My dialysis is effectively cleaning my blood.

I have signed the informed consent form.

I am an adult.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Washout

Participants stop all blood phosphate-lowering drugs

1-2 weeks

Initial Treatment

Participants take AP301 or the comparator three times a day

8 weeks

Extended Treatment

Participants take AP301 three times a day with dose adjustments

24 weeks

Final Treatment

Participants take AP301 or the comparator three times a day

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• AP301

Trial Overview The study tests if AP301 can lower blood phosphate in patients undergoing maintenance dialysis compared to a low dose version of the same drug, which serves as an ineffective comparator. It will also assess effects on serum calcium, calcium-phosphate product, parathyroid hormone levels, potential discomforts from taking AP301, and any improvements in quality of life.

Participant Groups

Group I: AP301 Low Dose Experimental Treatment 1 Intervention

A blood phosphate-lowering medication containing iron, but with a low dose considered as ineffective

Group II: AP301 Experimental Treatment 1 Intervention

A blood phosphate-lowering medication containing iron

Who Is Running the Clinical Trial?

Alebund Pharmaceuticals

Lead Sponsor

Trials

4

Recruited

240+

Fortrea

Industry Sponsor

Trials

22

Recruited

5,800+