Clinical trials: Hyperkalaemia
Hyperkalaemia
An Open-label Study to Assess Safety and Efficacy of SZC in Paediatric Patients With Hyperkalaemia
Sodium zirconium cyclosilicate has been shown to be effective and safe in adults for the treatment of hyperkalaemia, and therefore it is expected to be beneficial in children.
- Trial name
- PEDZ-K (NCT03813407)
- Testing
- Sodium Zirconium Cyclosilicate (SZC) Reduced Dose Level, Sodium Zirconium Cyclosilicate (SZC) Dose Level 1 (DL1), Sodium Zirconium Cyclosilicate (SZC) Dose Level 2 (DL2)
- Where
- 70 sites in United States, Brazil and 11 more
- Volunteers
- 140 people
- Sponsor
- AstraZeneca
Hyperkalaemia
VITALIZE.Use and Effectiveness of Sodium Zirconium Cyclosilicate (LokelmaTM) in the Real-world Setting in Spain
Primary Objective(s) \& Hypothesis(es) 1. To describe the status of kalaemia in patients treated with SZC in the real-world setting at first visit after treatment initiation. 2.
- Trial name
- VITALIZE (NCT06635499)
- Where
- 14 sites in Spain
- Volunteers
- 232 people
- Sponsor
- AstraZeneca
Hyperkalaemia
A National, Multicenter, Prospective, Observational Study to Assess Patient Characteristics, Treatment Algorithms and Disease Management of Hyperkalaemia Patients With Chronic Kidney Disease or Under Dialysis or With Heart Failure, Treated With Sodium Zirconium Cyclosilicate in Greece
This is a multicenter, observational, prospective, national study which includes patients with chronic kidney disease (CKD) under dialysis or not, or with heart failure (HF), treated with sodium zirconium cyclosilicate (SZC) as…
- Trial name
- SHIELD (NCT06185660)
- Testing
- sodium zirconium cyclosilicate (SZC)
- Where
- 10 sites in Greece
- Volunteers
- 125 people
- Sponsor
- AstraZeneca
Hyperkalaemia, Chronic Kidney Disease
Continuing Sodium Zirconium Cyclosilicate (SZC) After Discharge Study
This is an open-label, randomised study in participants with chronic kidney disease (CKD) treated for hyperkalaemia (HK) whilst in hospital.
- Trial name
- CONTINUITY (NCT05347693)
- Testing
- Sodium Zirconium Cyclosilicate (SZC), Local standard of care
- Where
- 28 sites in Belgium, France and 4 more
- Volunteers
- 186 people
- Sponsor
- AstraZeneca
Hyperkalaemia, Heart Failure With Reduced Ejection Fraction
Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients With Symptomatic HFrEF Receiving Spironolactone
The main objective of this study is to evaluate the efficacy of SZC as compared with placebo in keeping potassium levels within the normal range (3.5-5.0 mEq/L) while on spironolactone ≥25 mg daily without assistance of rescue…
- Trial name
- REALIZE-K (NCT04676646)
- Testing
- Sodium zirconium cyclosilicate, Spironolactone
- Where
- 89 sites in United States, Brazil and 6 more
- Volunteers
- 366 people
- Sponsor
- AstraZeneca
Hyperkalaemia
A Multicenter, Prospective, Non-interventional Cohort Study to Evaluate the Safety and Treatment Pattern of Sodium Zirconium Cyclosilicate for Hyperkalaemia Management in Real World Practice in China
The study is a multi-center prospective (primary data) non-interventional cohort study which enrolls 1500 patients including new and ongoing users on SZC at Study Enrollment Day in real-world clinical practice.
- Trial name
- ACTUALIZE (NCT05271266)
- Where
- 27 sites in China
- Volunteers
- 1,000 people
- Sponsor
- AstraZeneca
Hyperkalaemia
Safety of Oral Resin for Treatment of Hyperkalemia in Chinese Patients With Renal Insufficiency
It is a multicenter, prospective, non-interventional cohort study, in order to evaluate the safety of oral resin for treatment of hyperkalemia in Chinese patients with renal insufficiency.
- Trial name
- SCRUTINIZE (NCT05462119)
- Where
- 16 sites in China
- Volunteers
- 887 people
- Sponsor
- AstraZeneca
Hyperkalaemia
Study to Assess the Effect of Sodium Zirconium Cyclosilicate on the Pharmacokinetics of Tacrolimus and Cyclosporin in Healthy Subjects
This study will be an open-label, randomised sequence, 2-period, 2-cohort, 2-treatment in each cohort, cross-over study in healthy subjects (males and females of non-childbearing potential), performed at a single study centre.
- Trial name
- NCT04788641
- Testing
- Tacrolimus, Cyclosporin, Sodium Zirconium Cyclosilicate
- Where
- Germany
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Chronic Kidney Disease + Hyperkalaemia +/- Heart Failure
Patient Palatability and Preference of 3 Potassium Binders in Patients With Chronic Kidney Disease and Hyperkalaemia
This non-interventional, Phase IV, exploratory, cross-over, randomised, single-blind, active comparator-controlled study has been designed to measure the palatability and preference of Lokelma® versus Veltassa® versus S/CPS in…
- Trial name
- APPETIZE (NCT04566653)
- Testing
- Calcium Polystyrene Sulphonate 15g/60 mL water, Lokelma® 5 g/45mL water, Lokelma® 10 g/45 mL water
- Where
- 18 sites in United States, Canada and 4 more
- Volunteers
- 147 people
- Sponsor
- AstraZeneca
Hyperkalaemia, Metabolic Acidosis
Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease
The main objective of this study is to evaluate the efficacy of SZC as compared to placebo in maintaining normal sK+ in patients with hyperkalemia and metabolic acidosis associated with CKD
- Conditions
- Hyperkalaemia, Metabolic Acidosis, Chronic Kidney Disease
- Trial name
- NEUTRALIZE (NCT04727528)
- Testing
- Sodium zirconium cyclosilicate
- Where
- 30 sites in United States, Puerto Rico
- Volunteers
- 39 people
- Sponsor
- AstraZeneca
Hyperkalaemia
Study of SZC and Enhanced Nutrition Advice Compared to SoC in Dialysis Patients With Hyperkalaemia
Prescribing Sodium zirconium cyclosilicate (SZC) with enhanced nutritional advice to participants with hyperkalaemia on haemodialysis will reduce serum K+ (S-K+ ) and enable the consumption of more fruit and vegetables and more…
- Trial name
- GRAZE (NCT04997161)
- Testing
- Sodium Zirconium Cyclosilicate (SZC), Enhanced dietary advice, Standard dietary advice including K+ restriction.
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- AstraZeneca