Exploratory Study of ZG-801 for the Treatment of Hyperkalemia

Zeria Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Hyperkalemia

Treatments: Drug: placebo; Drug: patiromer

Study type: Interventional

Funder types: Industry

Identifiers

NCT03799926

ZG-801-01

Details and patient eligibility

About

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.

Enrollment: 184 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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184 participants in 8 patient groups

Stratum 1: 8.4 g patiromer

Experimental group

Description:

Non-dialysis subjects with serum potassium 5.1 to \< 6.0 mEq/L range at baseline

Treatment:

Drug: patiromer

Drug: patiromer

Drug: patiromer

Drug: patiromer

Drug: patiromer

Drug: patiromer

Stratum 1: 16.8 g patiromer

Experimental group

Description:

Non-dialysis subjects with serum potassium 5.1 to \< 6.0 mEq/L range at baseline

Treatment:

Drug: patiromer

Drug: patiromer

Drug: patiromer

Drug: patiromer

Drug: patiromer

Drug: patiromer

Stratum 1: placebo of 8.4 g patiromer

Experimental group

Description:

Non-dialysis subjects with serum potassium 5.1 to \< 6.0 mEq/L range at baseline

Treatment:

Drug: placebo

Drug: placebo

Stratum 1: placebo of 16.8 g patiromer

Experimental group

Description:

Non-dialysis subjects with serum potassium 5.1 to \< 6.0 mEq/L range at baseline

Treatment:

Drug: placebo

Drug: placebo

Stratum 2: 8.4 g patiromer

Experimental group

Description:

Non-dialysis subjects with serum potassium 6.0 to \< 6.5 mEq/L range at baseline

Treatment:

Drug: patiromer

Drug: patiromer

Drug: patiromer

Drug: patiromer

Drug: patiromer

Drug: patiromer

Stratum 2: 16.8 g patiromer

Experimental group

Description:

Non-dialysis subjects with serum potassium 6.0 to \< 6.5 mEq/L range at baseline

Treatment:

Drug: patiromer

Drug: patiromer

Drug: patiromer

Drug: patiromer

Drug: patiromer

Drug: patiromer

Stratum 3: 8.4 g patiromer

Experimental group

Description:

Dialysis subjects with serum potassium 5.5 to \< 6.5 mEq/L range at baseline

Treatment:

Drug: patiromer

Drug: patiromer

Drug: patiromer

Drug: patiromer

Drug: patiromer

Drug: patiromer

Stratum 3: 16.8 g patiromer

Experimental group

Description:

Dialysis subjects with serum potassium 5.5 to \< 6.5 mEq/L range at baseline

Treatment:

Drug: patiromer

Drug: patiromer

Drug: patiromer

Drug: patiromer

Drug: patiromer

Drug: patiromer