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A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia

NCT06712654 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2026-05-22

No results posted yet for this study

Summary

This study is being conducted to characterize the safety, tolerability, and efficacy of AP306 at fixed doses in adults with hyperphosphatemia receiving maintenance hemodialysis.

Conditions

  • Hyperphosphatemia
  • Chronic Kidney Disease Requiring Chronic Dialysis
  • End Stage Renal Disease on Dialysis

Interventions

DRUG

AP306 75 mg BID

AP306 75 mg by mouth, twice daily (150 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.

DRUG

AP306 125 mg BID

AP306 125 mg by mouth, twice daily (250 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.

DRUG

AP306 150 mg BID

AP306 150 mg by mouth, twice daily (300 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.

DRUG

AP306 75 mg TID

AP306 75 mg by mouth, three times daily (225 mg/day). Treatment given daily for 8 weeks.

DRUG

AP306 100 mg TID

AP306 100 mg by mouth, three times daily (300 mg/day). Treatment given daily for 8 weeks.

DRUG

AP306 125 mg TID

AP306 125 mg by mouth, three times daily (375 mg/day). Treatment given daily for 8 weeks.

DRUG

Placebo

Placebo given by mouth, three times daily. Treatment given daily for 8 weeks.

Sponsors & Collaborators

  • Alebund Pharmaceuticals

    collaborator INDUSTRY

  • R1 Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-02-28
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States
  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06712654 on ClinicalTrials.gov