Exploratory Study of ZG-801 for the Treatment of Hyperkalemia

NCT03799926 | Completed Phase 2

• 1 other identifier: ZG-801-01
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperkalemia

Outcome Measures

Primary Outcomes (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 Outcomes (4)

• Change in serum potassium 4 weeks after the start of administration in each group of starting dose

  Baseline to week 4

• 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

• Incidence of adverse events

  Over 52-week study period

• Incidence of adverse drug reactions

  Over 52-week study period

Study Arms (8)

Stratum 1: 8.4 g patiromer

EXPERIMENTAL

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

Drug: patiromer

Stratum 1: 16.8 g patiromer

EXPERIMENTAL

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

Drug: patiromer

Stratum 1: placebo of 8.4 g patiromer

EXPERIMENTAL

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

Drug: placebo

Stratum 1: placebo of 16.8 g patiromer

EXPERIMENTAL

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

Drug: placebo

Stratum 2: 8.4 g patiromer

EXPERIMENTAL

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

Drug: patiromer

Stratum 2: 16.8 g patiromer

EXPERIMENTAL

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

Drug: patiromer

Stratum 3: 8.4 g patiromer

EXPERIMENTAL

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

Drug: patiromer

Stratum 3: 16.8 g patiromer

EXPERIMENTAL

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

Drug: patiromer

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)

Stratum 1: 8.4 g patiromer

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)

Stratum 1: placebo of 8.4 g patiromer

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Zeria Pharmaceutical: lead

Study Sites (1)

Zeria Investigative Sites

Kanagawa, Japan

Location

MeSH Terms

Conditions

Hyperkalemia

Interventions

patiromer

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 10, 2019
• Study Start: February 18, 2019
• Primary Completion: November 6, 2019
• Study Completion: February 2, 2021
• Last Updated: March 25, 2021

Record last verified: 2021-03

Locations

JP (1)