Exploratory Study of ZG-801 for the Treatment of Hyperkalemia

• Sponsor: Zeria Pharmaceutical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03799926
• Collaborator: (none)
• Enrollment: 184
• Location: 1
• Arms: 8
• Actual Duration (Months): 23.5
• Patients Per Site Per Month: 7.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hyperkalemia	Drug: patiromer; Drug: patiromer; Drug: placebo; Drug: placebo; Drug: patiromer; Drug: patiromer; Drug: patiromer; Drug: patiromer	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 184 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: ZG-801 Phase II Trial - Exploratory Study of Efficacy and Safety on Patients With Hyperkalemia, and Long Term Safety Study -
• Actual Study Start Date: Feb 18, 2019
• Actual Primary Completion Date: Nov 6, 2019
• Actual Study Completion Date: Feb 2, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stratum 1: 8.4 g patiromer Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline	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)
Experimental: Stratum 1: 16.8 g patiromer Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline	Drug: 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)
Experimental: Stratum 1: placebo of 8.4 g patiromer Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline	Drug: 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)
Experimental: Stratum 1: placebo of 16.8 g patiromer Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline	Drug: 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)
Experimental: Stratum 2: 8.4 g patiromer Non-dialysis subjects with serum potassium 6.0 to < 6.5 mEq/L range at baseline	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 2)
Experimental: Stratum 2: 16.8 g patiromer Non-dialysis subjects with serum potassium 6.0 to < 6.5 mEq/L range at baseline	Drug: 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)
Experimental: Stratum 3: 8.4 g patiromer Dialysis subjects with serum potassium 5.5 to < 6.5 mEq/L range at baseline	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 3)
Experimental: Stratum 3: 16.8 g patiromer Dialysis subjects with serum potassium 5.5 to < 6.5 mEq/L range at baseline	Drug: 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)

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Change in serum potassium 4 weeks after the start of administration in each group of starting dose [Baseline to week 4]

2. 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]

3. Incidence of adverse events [Over 52-week study period]

4. Incidence of adverse drug reactions [Over 52-week study period]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zeria Investigative Sites	Kanagawa		Japan

Sponsors and Collaborators

• Zeria Pharmaceutical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zeria Pharmaceutical
• ClinicalTrials.gov Identifier: NCT03799926
• Other Study ID Numbers: ZG-801-01
• First Posted: Jan 10, 2019
• Last Update Posted: Mar 25, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hyperkalemia

Study Results

No Results Posted as of Mar 25, 2021