Clinical trial NCT03799926: Exploratory Study of ZG-801 for the Treatment of Hyperkalemia
Official title: ZG-801 Phase II Trial - Exploratory Study of Efficacy and Safety on Patients With Hyperkalemia, and Long Term Safety Study -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperkalemia
Lead sponsor: Zeria Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2019-01-10
Enrollment: 184
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in serum potassium from baseline to 1 week after the start of administration in each group of starting dose
timeFrame: Baseline to week 1
Secondary outcomes:
measure: Change in serum potassium 4 weeks after the start of administration in each group of starting dose
timeFrame: Baseline to week 4
measure: Proportion of subjects with a normalized serum potassium level at 4 weeks after the start of administration in each group of starting dose
timeFrame: Week 4
measure: Incidence of adverse events
timeFrame: Over 52-week study period
measure: Incidence of adverse drug reactions
timeFrame: Over 52-week study period
Other outcomes:
Locations:
city: Kanagawa
country: Japan
facility: Zeria Investigative Sites
Study officials:
References: