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Completed

NCT Number: NCT04955678

A Comparative Study of ZG-801 and Placebo in Patients With Hyperkalemia

The purpose of this study is to evaluate the superiority of ZG-801 to placebo in Japanese hyperkalemia patients whose serum potassium value becomes normal in the Run-in period by comparing the change in the value at the Double-blind period week 4, and to further evaluate the efficacy and safety of ZG-801 in Japanese hyperkalemia patients administrated ZG-801 for maximum 9 weeks.

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Key information

Conditions

Hyperkalemia Metabolic Diseases Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Zeria Investigative Site

Hitachi-Naka, Ibaraki, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients whose serum potassium value (local) at the Run-in period baseline is ≥5.5mEq/L, < 6.5 mEq/L
  • Age 20 - 80 years old at informed consent
  • Patients who understand an overview of the study and voluntarily consented to participate in the study by documents.

Main Exclusion Criteria:

  • Patients determined to require emergency treatment for hyperkalemia at the Run-in period baseline
  • Patients with poorly controlled blood pressure
  • Patients with heart failure in New York Heart Association Class IV
  • Patients who have experienced heart transplant, liver transplant or kidney transplant or who are predicted that the need for them will occur during the study
  • Patients who have taken any of the following medication within 7 days prior to the Run-in period baseline or currently administrated.
  • Sodium polystyrene sulfonate
  • Calcium polystyrene sulfonate
  • Sodium zirconium cyclosilicate hydrate
  • Potassium supplement
  • Patients with or who have experienced a severe swallowing disorder, moderate to severe gastroparesis, severe constipation, bowel obstruction, incarceration, abnormal post-operative bowel motility disorders or severe gastrointestinal disorders. In addition, patients who have experienced bariatric surgery or major gastrointestinal surgery (e.g., bowel resection).
  • Patients suspected to be with transient high potassium value.(ex. caused by dietary effects only)

Treatment and study plan

Calcium, hydrolysed divinylbenzene-Me 2-fluoro-2-propenoate-1, 7-octadiene polymer sorbitol complexes

Drug

ZG-801 is powder for suspension. In Run-in period, ZG-801 is taken once a day for 4 or 5 weeks. In Double-blind period, ZG-801 is taken once a day for 4 weeks.

Placebo

Drug

Placebo is powder for suspension. In Double-blind period, Placebo is taken once a day for 4 weeks.

Primary outcomes

  1. Change in serum potassium value at Double-blind period week4

    Time frame: Double-blind period baseline to Double-blind period week4

Secondary outcomes

  1. Maintenance of serum potassium value within 3.5 mEq/L to < 5.1 mEq/L or within 3.5 mEq/L to <5.5 mEq/L in Double-blind Period

    Time frame: Double-blind period baseline to Double-blind period week4

  2. Time to First Non-maintenance of Serum Potassium Value in Double-blind Period

    Time frame: Double-blind period baseline to Double-blind period week4

  3. RAASi dose sustaining proportion

    Time frame: Double-blind period baseline to Double-blind period week4

  4. Change in Serum Potassium Value

    Time frame: Run-in period baseline to Run-in period week 5

Sponsors and collaborators

Lead sponsor

Zeria Pharmaceutical

Industry

Registry information

Official study title

ZG-801 Phase III Trial - Randomized, Double-blind, Placebo-controlled Trial of ZG-801 in Patients With Hyperkalemia -

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 9, 2021
Registry last updated
Apr 20, 2023

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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