Exploratory Study of ZG-801 for the Treatment of Hyperkalemia

Sponsor
Zeria Pharmaceutical
Study ID
NCT03799926
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • patiromer — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    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)

Study Details

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.

Key Dates

Start date
Feb 18, 2019
Status verified
Mar 2021
Primary completion
Nov 6, 2019
Completion
Feb 2, 2021

Study Design

Enrollment
184 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Stratum 1: 8.4 g patiromer
    Non-dialysis subjects with serum potassium 5.1 to \< 6.0 mEq/L range at baseline
  • Experimental: Stratum 1: 16.8 g patiromer
    Non-dialysis subjects with serum potassium 5.1 to \< 6.0 mEq/L range at baseline
  • 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
  • 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
  • Experimental: Stratum 2: 8.4 g patiromer
    Non-dialysis subjects with serum potassium 6.0 to \< 6.5 mEq/L range at baseline
  • Experimental: Stratum 2: 16.8 g patiromer
    Non-dialysis subjects with serum potassium 6.0 to \< 6.5 mEq/L range at baseline
  • Experimental: Stratum 3: 8.4 g patiromer
    Dialysis subjects with serum potassium 5.5 to \< 6.5 mEq/L range at baseline
  • Experimental: Stratum 3: 16.8 g patiromer
    Dialysis subjects with serum potassium 5.5 to \< 6.5 mEq/L range at baseline

Primary Outcome Measure

Change in serum potassium from baseline to 1 week after the start of administration in each group of starting dose [ Time Frame: Baseline to week 1 ]

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