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AP301 Efficacy and Safety in Chinese Dialysis Patients With Hyperphosphatemia

NCT07030595 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 474

Last updated 2025-11-17

No results posted yet for this study

Summary

This Phase 3 clinical trial is the pivotal study of AP301 aiming to evaluate the efficacy and safety of AP301 for controlling serum phosphorus in chronic kidney disease receiving hemodialysis and peritoneal dialysis in Chinese patients with hyperphosphatemia.

Conditions

  • ESRD (End Stage Renal Disease)
  • Chronic Kidney Disease(CKD)
  • Hyperphosphatemia
  • Hyperphosphatemia in Chronic Kidney Disease
  • Dialysis
  • Chronic Kidney Disease, Receiving Dialysis

Interventions

DRUG

AP301

Three times a day, administered orally with three meals at a daily dose level from 2.1g to 9.1g

DRUG

Sevelamer carbonate (Renvela®)

Three times a day, administered orally with three meals at a daily dose level from 2.4g to 9.6g

DRUG

AP301 Low Dose

Three times a day, administered orally with three meals at a daily dose level of 0.375g.

Sponsors & Collaborators

  • Alebund Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-12
Primary Completion
2024-10-02
Completion
2025-05-30

Countries

  • China

Study Locations

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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 NCT07030595 on ClinicalTrials.gov