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ZS Ph2/3 Dose-response Study in Japan

NCT03127644 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2019-05-20

Study results available
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Summary

To assess efficacy of 5 g three times daily (TID) and 10 g TID ZS versus placebo in Japanese patients with hyperkalemia (serum potassium \[S-K\] ≥ 5.1 mmol/L and ≤ 6.5 mmol/L).

Conditions

  • Hyperkalemia

Interventions

DRUG

Sodium Zirconium Cyclosilicate (ZS) 5g

Suspension administered 5g orally three times daily for 48 hours.

DRUG

Sodium Zirconium Cyclosilicate (ZS) 10g

Suspension administered 10g orally three times daily for 48 hours.

DRUG

Placebo

Placebo suspension administered orally placebo three times daily for 48 hours.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-14
Primary Completion
2018-02-23
Completion
2018-02-23

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03127644 on ClinicalTrials.gov