NCT03799926

Exploratory Study of ZG-801 for the Treatment of Hyperkalemia

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: Zeria Pharmaceutical · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperkalemia

Interventions

Type	Name	Description
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)
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)
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)
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)
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)
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)
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)
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)

Timeline

• Start date: 2019-02-18
• Primary completion: 2019-11-06
• Completion: 2021-02-02
• First posted: 2019-01-10
• Last updated: 2021-03-25

Locations

1 site across 1 country: Japan