Exploratory Study of ZG-801 for the Treatment of Hyperkalemia

Hyperkalemia Clinical Trial

Official title:

ZG-801 Phase II Trial - Exploratory Study of Efficacy and Safety on Patients With Hyperkalemia, and Long Term Safety Study -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03799926
• Other study ID #: ZG-801-01
• Status: Completed
• Phase: Phase 2
• Start date: February 18, 2019
• Est. completion date: February 2, 2021

Study information

• Verified date: March 2021
• Source: Zeria Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the efficacy of each ZG-801 starting dose and the titration algorithm of ZG-801 for the treatment of hyperkalemia in Japanese patients.

To evaluate the safety of ZG-801 for the chronic use (total over 52 weeks). In addition, to confirm the safety after the discontinuation of ZG-801 treatment on 1 week follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: February 2, 2021
• Est. primary completion date: November 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Males and females ages 18 - 80

• Informed consent given

• Serum Potassium measurement at baseline is 5.1 to < 6.5 mEq/L (Non-dialysis patients or 5.5 to < 6.5 mEq/L (Dialysis patients)

Exclusion Criteria:

• Subjects with hospitalization for hyper- or hypoglycemia with Type 2 diabetes or for acute exacerbations of heart failure within the previous 3 months

• Subjects with severe heart failure, defined as NYHA (New York Heart Association) class IV

• Subjects with uncorrected hemodynamically significant primary vascular disease or uncontrolled or hemodynamically unstable arrhythmia

• Subjects with coronary artery bypass graft, percutaneous intervention, or major surgery including thoracic and cardiac, within the previous 3 months or anticipated need during study participation

• Subjects with heart, liver (only Dialysis patients), or kidney transplant recipient, or anticipated need for transplant during the study period

• Subjects with any of the significant cardiovascular or cerebrovascular events within the previous 2 months

• Subjects with a history of or current diagnosis of a severe swallowing disorder, moderate to severe gastroparesis, or history of bariatric surgery, bowel obstruction or severe gastrointestinal disorders or major gastrointestinal surgery

• Subjects who cannot use the oral concomitant medication to be separate 3 hours from ZG-801 medication

• Subjects suspected of transient high potassium levels, such as those caused only by dietary effects

Related Conditions & MeSH terms

• Hyperkalemia

Intervention

Drug:
• patiromer
Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)
• patiromer
Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)
• placebo
Placebo starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)
• placebo
Placebo starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)
• patiromer
Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 2)
• patiromer
Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 2)
• patiromer
Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 3)
• patiromer
Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 3)

Locations

Country	Name	City	State
Japan	Zeria Investigative Sites	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Zeria Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum potassium from baseline to 1 week after the start of administration in each group of starting dose		Baseline to week 1
Secondary	Change in serum potassium 4 weeks after the start of administration in each group of starting dose		Baseline to week 4
Secondary	Proportion of subjects with a normalized serum potassium level at 4 weeks after the start of administration in each group of starting dose		Week 4
Secondary	Incidence of adverse events		Over 52-week study period
Secondary	Incidence of adverse drug reactions		Over 52-week study period