A Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ZS) Among Patients With S-K ≥5.8
Completed · Phase 2 · Has a placebo group
Conditions studied: Hyperkalemia
In brief
The study is designed to determine if ZS 10g administered up to three times over 10h added to insulin and glucose in patients presenting with hyperkalemia will prove tolerable and efficacious. Patients will receive ZS or Placebo on top of standard of care treatment with insulin and glucose.
Key facts
- Study ID
- NCT03337477
- Run by
- AstraZeneca
- People needed
- 70
- Starts
- 2018-02-13
- Expected to finish
- 2018-12-21
- Last updated by the study team
- 2020-01-28
Who can join
Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 18 years of age
- Potassium ≥5.8 mmol/L
You may not qualify if…
- Possible pseudohyperkalaemia
- Hyperkalaemia caused by any condition for which a therapy directed against the underlying cause of hyperkalaemia would be a better treatment option than treatment with insulin and glucose.
- Dialysis session expected within 4h after randomization
- Treated with any therapy intended to lower S-K between arriving at the hospital and randomization during Visit 1.
Where it is running
- Research Site — Montgomery, Alabama, United States
- Research Site — Phoenix, Arizona, United States
- Research Site — Detroit, Michigan, United States
- Research Site — Detroit, Michigan, United States
- Research Site — Detroit, Michigan, United States
- Research Site — Royal Oak, Michigan, United States
- Research Site — St Louis, Missouri, United States
- Research Site — Stony Brook, New York, United States
- Research Site — Durham, North Carolina, United States
- Research Site — Winston-Salem, North Carolina, United States
- Research Site — El Paso, Texas, United States
- Research Site — Houston, Texas, United States
- Research Site — Esbjerg, Denmark
- Research Site — Herning, Denmark
- Research Site — Novara, Italy
- Research Site — Piombino, Italy
- Research Site — Kemerovo, Russia
- Research Site — Kemerovo, Russia
- Research Site — Moscow, Russia
- Research Site — Moscow, Russia
- Research Site — Perm, Russia
- Research Site — Ryazan, Russia
- Research Site — Saint Petersburg, Russia
- Research Site — Yaroslavl, Russia
- Research Site — Yekaterinburg, Russia
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.