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

NCT04955678 | Completed Phase 3

• 1 other identifier: ZG-801-02
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperkalemia

Outcome Measures

Primary Outcomes (1)

• Change in serum potassium value at Double-blind period week4

  Double-blind period baseline to Double-blind period week4

Secondary Outcomes (4)

• 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

  Double-blind period baseline to Double-blind period week4

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

  Double-blind period baseline to Double-blind period week4

• RAASi dose sustaining proportion

  Double-blind period baseline to Double-blind period week4

• Change in Serum Potassium Value

  Run-in period baseline to Run-in period week 5

Study Arms (2)

ZG-801

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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.

ZG-801

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Zeria Pharmaceutical: lead

Study Sites (1)

Zeria Investigative Site

Hitachi-Naka, Ibaraki, Japan

Location

MeSH Terms

Conditions

Hyperkalemia

Interventions

Calcium

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

Study Officials

• Yusuke Tomioka

  Zeria Pharmaceutical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 9, 2021
• Study Start: August 3, 2021
• Primary Completion: December 26, 2022
• Study Completion: March 13, 2023
• Last Updated: April 20, 2023

Record last verified: 2022-10

Locations

JP (1)