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Completed

NCT Number: NCT05764590

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

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.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperphosphatemia Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Phosphorus Metabolism Disorders Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Important Inclusion Criteria:

  • On a stable hemodialysis regimen at a frequency of three times per week for at least 12 weeks prior to the screening visit
  • Dialysis sufficiency SpKt/V ≥ 1.2 at the screening visit or any documented result within 12 weeks prior to the screening visit
  • Serum phosphorus within the trial-required range

Important Exclusion Criteria:

  • Pregnant or breastfeeding
  • Any history of kidney transplant
  • Any history of a parathyroid intervention
  • Any clinically significant GI disorders within 4 weeks prior to the screening visit
  • Hospitalization for cardiac or cerebrovascular disease within 24 weeks prior to the screening visit
  • Hospitalization for cardiac or cerebrovascular disease within 24 weeks prior to the screening visit
  • 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

Treatment and study plan

AP-306

Drug

A blood phosphorus lowering drug with a novel mechanism

Sevelamer carbonate

Drug

A phosphate binder

Primary outcomes

  1. To evaluate the efficacy of AP-306 assessed by serum phosphorus lowering

    Time frame: 12 weeks

    The change in serum phosphorus level from the baseline to the end of treatment

Other outcomes

  1. To evaluate the overall safety of AP-306 assessed by incidence of treatment-emergent adverse events

    Time frame: 15 weeks

    All adverse events occurred after the study treatment initiation will be collected and their nature, frequency, and severity will be assessed.

Sponsors and collaborators

Lead sponsor

Alebund Pharmaceuticals

Industry

Registry information

Official study title

A Phase 2, Randomized, Open-Label, Active-Controlled, Multicenter Study to Evaluate the Safety and Serum Phosphorus Lowering Effect of AP-306 in Chronic Kidney Disease Patients Receiving Maintenance Hemodialysis With Hyperphosphatemia

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 10, 2023
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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