Clinical trials: Hyperkalemia
Hyperkalemia
Open-label Safety of Sodium Zirconium Cyclosilicate for up to 12 Months in Japanese Subjects With Hyperkalemia
The Open-Label Maintenance Study contains an Correction Phase, in which subjects will be dosed with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a 12-month long-term Maintenance Phase.
- Trial name
- NCT03172702
- Testing
- Zirconium Cyclosilicate
- Where
- 42 sites in Japan
- Volunteers
- 150 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
Hyperkalemia, Renal Insufficiency, Chronic
Trial Evaluating the Efficacy and Safety of Patiromer in Chinese Subjects
This is a multicentre, 2-part, single-blind, randomised, withdrawal, placebo-controlled study, that includes a 4-week patiromer treatment phase (Part A) followed by an 8-week randomised placebo-controlled withdrawal phase (Part…
- Trial name
- Patiromer JADE (NCT05136664)
- Testing
- Patiromer Powder for Oral Suspension (Part A), Patiromer Powder for Orals Suspension (Part B)
- Where
- 28 sites in China
- Volunteers
- 262 people
- Sponsor
- Vifor Fresenius Medical Care Renal Pharma
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
Hyperkalemia
A Two-Part, Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia
This clinical trial consists of 2 parts, Part A and Part B. Part A consists of a 2-day randomized, double-blind, placebo-controlled corrective phase (CP) and a 28-day randomized, double-blind, placebo-controlled maintenance phase…
- Trial name
- NCT07251309
- Testing
- WS016
- Where
- 50 sites in China
- Volunteers
- 420 people
- Sponsor
- Waterstone Pharmaceutical (Wuhan) Co., LTD.
Chronic Kidney Disease, Hyperkalemia
A Multicenter Study to Evaluate the Nutritional Suitability of Renastart
A multicenter, open label, uncontrolled study to evaluate the acceptability, tolerability, and nutritional suitability of a medical food (Renastart, Vitaflo International Ltd) specially formulated to meet the unique nutritional…
- Trial name
- Renastart (NCT02825784)
- Testing
- Renastart
- Where
- 3 sites in Germany
- Volunteers
- 12 people
- Sponsor
- Vitaflo International, Ltd
Hyperkalemia
Safety and Efficacy of Sodium Polystyrene Sulfonate in Hyperkalemia
It is hypothesized that SPS is more effective than placebo control (alternative hypothesis) in lowering i-STAT potassium levels in subjects with i-STAT potassium levels between 5.0 - 6.5 mmol/l versus no difference between SPS…
- Trial name
- NCT01866709
- Testing
- Sodium polystyrene sulfonate, Silicified microcrystalline cellulose
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- ZS Pharma, Inc.
Hyperkalemia
Observational Study on the Prevalence and Risk Factors of Patients With Hyperkalaemia in Brazil
This is a descriptive, retrospective study involving patients from private cardiology, nephrology, and dialysis clinics in Brazil who participated in the National Hyperkalaemia Diagnosis Campaign.
- Trial name
- HOPE (NCT07370194)
- Where
- Brazil
- Volunteers
- 6,215 people
- Sponsor
- AstraZeneca
Hyperkalemia
ZS Ph2/3 Dose-response Study in Japan
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).
- Trial name
- NCT03127644
- Testing
- Sodium Zirconium Cyclosilicate (ZS) 5g, Sodium Zirconium Cyclosilicate (ZS) 10g
- Where
- 25 sites in Japan
- Volunteers
- 103 people
- Sponsor
- AstraZeneca
Hyperkalemia
A Study Evaluating the Safety and Efficacy of RDX013 for the Treatment of Hyperkalemia
The purpose of this study is to evaluate the ability of RDX013 to lower serum potassium in patients with chronic kidney disease with elevated serum potassium levels
- Trial name
- Redukx (NCT04780841)
- Testing
- RDX013
- Where
- 6 sites in United States
- Volunteers
- 109 people
- Sponsor
- Ardelyx
Hyperkalemia
Pharmacodynamic & Safety of Patiromer in Children & Adolescents (2-<18 Yrs) With Chronic Kidney Disease and Hyperkalemia
The purpose of this study is to evaluate the change in serum potassium levels from start of treatment to Day 14, when patiromer is administered at different doses, once daily, in children 2 - < 18 years of age with chronic kidney…
- Trial name
- EMERALD (NCT03087058)
- Testing
- Patiromer
- Where
- 30 sites in United States, Bulgaria and 5 more
- Volunteers
- 23 people
- Sponsor
- Vifor Pharma, Inc.
Hyperkalemia
A Comparative Study of ZG-801 and Placebo in Patients With Hyperkalemia
The purpose of this study is to evaluate the superiority of ZG-801 to placebo in Japanese hyperkalemia patients whose serum potassium value becomes normal in the Run-in period by comparing the change in the value at the…
- Trial name
- NCT04955678
- Testing
- Calcium, hydrolysed divinylbenzene-Me 2-fluoro-2-propenoate-1, 7-octadiene polymer sorbitol complexes
- Where
- Japan
- Volunteers
- 85 people
- Sponsor
- Zeria Pharmaceutical
Hyperkalemia, Hemodialysis
Hyperkalaemia Prevalence, Recurrence and Treatment in Haemodialysis
The objective of this study is to evaluate the prevalence and recurrence of Hyperkalaemia (HK) in Chinese HD patients and to understand the treatment pattern of HK in China.
- Conditions
- Hyperkalemia, Hemodialysis, Water-Electrolyte Imbalance
- Trial name
- PRECEDE-K (NCT04799067)
- Testing
- observational study
- Where
- 12 sites in China
- Volunteers
- 600 people
- Sponsor
- AstraZeneca
Hyperkalemia
A Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ZS) Among Patients With S-K ≥5.8
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.
- Trial name
- ENERGIZE (NCT03337477)
- Testing
- Sodium Zirconium Cyclosilicate(ZS), Insulin, Glucose
- Where
- 25 sites in United States, Denmark and 2 more
- Volunteers
- 70 people
- Sponsor
- AstraZeneca
Hyperkalemia
Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)
The purpose of this study is to evaluate the effect of Sodium Zirconium Cyclosilicate (SZC) on arrhythmia-related cardiovascular outcomes in participants on chronic hemodialysis with recurrent hyperkalemia.
- Trial name
- NCT04847232
- Testing
- Sodium Zirconium Cyclosilicate (SZC)
- Where
- 340 sites in United States, Argentina and 24 more
- Volunteers
- 2,690 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
Hyperkalemia, Resistant Hypertension
Spironolactone With Patiromer in the Treatment of Resistant Hypertension in Chronic Kidney Disease
The purpose of this study is to determine if patiromer treatment in chronic kidney disease (CKD) subjects receiving spironolactone for the treatment of resistant hypertension will result in more persistent use of spironolactone…
- Trial name
- AMBER (NCT03071263)
- Testing
- Patiromer, Spironolactone
- Where
- 40 sites in United States, Bulgaria and 7 more
- Volunteers
- 295 people
- Sponsor
- Relypsa, Inc.
Hyperkalemia Elevated Plasma K+ Cardiovascular Disease (CVD)
Retrospective Study to Describe Prevalence of Hyperkalemia in Russian Population Based on Large Laboratory Network (HEKATE)
This is a cross-sectional retrospective study of laboratory records of patients who take electrolytes blood tests containing the data of the serum potassium level.
- Trial name
- NCT03657875
- Where
- Russia
- Volunteers
- 53,940 people
- Sponsor
- AstraZeneca
Hyperkalemia
An Observational Prospective Cohort Study for Long-term Management of Hyperkalemia in Patients With Chronic Kidney Disease or Heart Failure
This prospective observational research will be conducted to assess the burden of hyperkalemia including treatment and disease burden of patients in a long-term continuous care from various aspects including adherence to the…
- Trial name
- HK registry (NCT05297409)
- Where
- 32 sites in Japan
- Volunteers
- 352 people
- Sponsor
- AstraZeneca
Hyperkalemia
A Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS)
This is a single center, inpatient, open label pharmacodynamic study to determine the effect of 5 g and 10 g doses of Sodium Zirconium Cyclosilicate (ZS) administered once daily (qd) for 4 days on potassium and sodium excretion…
- Trial name
- NCT03283267
- Testing
- Sodium Zirconium Cyclosilicate (ZS)
- Where
- Hong Kong
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- AstraZeneca