NCT02163499

Open-label Safety and Efficacy of Sodium Zirconium Cyclosilicate for up to 12 Months

Multicenter, Multi-Dose, Open-Label Maintenance of Long-Term Safety and Efficacy of Sodium Zirconium Cyclosilicate (ZS) in Hyperkalemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 751 (actual)
• Sponsor: ZS Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Open-Label Maintenance Study contains an Acute Phase, in which subjects will be dosed with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a long-term Maintenance Phase.

Detailed description

Subjects with 2 consecutive i STAT potassium values 5.1 mmol/L will enter the Acute Phase and receive ZS 10 g tid for 24 to 72 hours, depending on potassium values. Once normokalemia (i STAT potassium between 3.5 and 5.0 mmol/L, inclusive) is restored (whether after 24, 48 or 72 hours), subjects will be enrolled in the Maintenance Phase to be dosed with ZS at a starting dose of 5 g qd. Potassium (i STAT and central laboratory) will be measured weekly throughout the first month of study and every 4 weeks thereafter through Month 12. During the Maintenance Phase, the ZS dose may be increased or decreased in increments/decrements of 5 g qd up to a maximum of 15 g qd or a minimum of 5 g every other day based on i STAT potassium measurements as outlined below: • \> 5.0 mmol/L while receiving 5 g qd or 5 g every other day or \> 5.5 mmol/L while receiving 10 g qd: increase ZS dose in 5 g qd increments to a maximum dose of 15 g qd .• Between 3.0 and 3.4 mmol/L, inclusive: decrease ZS dose in 5 g qd decrements to a minimum dose of 5 g every other day; if a subject's i STAT potassium value remains between 3.0 and 3.4 mmol/L, inclusive, on the ZS 5 g every other day dose, the subject will be withdrawn from the study and receive standard of care treatment. There is no limit to the number of dose titrations allowed. Subjects will receive up to 12 months of treatment with open-label ZS.

Conditions

• Hyperkalemia

Interventions

Type	Name	Description
DRUG	Sodium Zirconium Cyclosilicate	Acute Phase Dosing: Sodium Zirconium Cyclosilicate 10 g three times daily (TID) for 24 to 72 Extended Dosing: Sodium Zirconium Cyclosilicate 5 g once daily (QD). Sodium Zirconium Cyclosilicate dose increased or decreased in increments/decrements of 5 g QD up to a maximum of 15 g QD or a minimum of 5 g every other day (QOD) based on i-STAT potassium measurements up to 12 months.

Timeline

• Start date: 2014-06-30
• Primary completion: 2016-11-30
• Completion: 2016-11-30
• First posted: 2014-06-13
• Last updated: 2018-06-27
• Results posted: 2018-06-27

Locations

50 sites across 7 countries: United States, Australia, Germany, Netherlands, Romania, South Africa, United Kingdom