Study identifier:D9480C00006
ClinicalTrials.gov identifier:NCT03303521
EudraCT identifier:2017-003029-14
CTIS identifier:N/A
A phase 3b, multicenter, prospective, randomized, double blind, placebocontrolled study to reduce incidence of pre-dialysis hyperkalemia with Sodium Zirconium Cyclosilicate (DIALIZE)
Hyperkalemia
Phase 3
No
Placebo, Sodium Zirconium Cyclosilicate (ZS)
All
196
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Feb 2020 by AstraZeneca
AstraZeneca
-
The purpose of this study is to evaluate the efficacy of ZS in the treatment of hyperkalemia in patients on hemodialysis.
Location
Location
Kansas City, MO, United States, 64108
Location
Fresh Meadows, NY, United States, 11365
Location
East Providence, RI, United States, 02914
Location
Great Neck, NY, United States, 11021
Location
Paterson, NJ, United States, 07504
Location
Bronx, NY, United States, 10461
Location
Whittier, CA, United States, 90606
Location
St-Petersburg, Russian Federation, 196247
Arms | Assigned Interventions |
---|---|
Experimental: Sodium Zirconium Cyclosilicate (ZS) Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) Single dose contains from 1 to 3 sachets of ZS 5g depending on dose level assigned to a patient per non-dialysis days. | Drug: Sodium Zirconium Cyclosilicate (ZS) Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) . Single dose contains from 1 to 3 sachets of ZS 5g depending on dose level assigned to a patient per non-dialysis days. |
Placebo Comparator: Placebo Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) Single dose contains from 1 to 3 sachets of Placebo depending on dose level assigned to a patient per non-dialysis days. | Drug: Placebo Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) . Single dose contains from 1 to 3 sachets of Placebo depending on dose level assigned to a patient per non-dialysis days. |
This information is not intended to replace the informed medical advice or medical treatments of a healthcare professional. Only a physician can determine if a specific medicine is the correct treatment for a particular patient. If you have questions regarding any information contained in this site, you must consult a suitably qualified healthcare professional. Before prescribing any AstraZeneca products, Healthcare Professionals should view their country specific information.