Clinical trials: Hyperkalemia
Hyperkalemia
Safety & Efficacy of Zirconium Silicate in Mild to Moderate Hyperkalemia
Acute Phase: It is hypothesized that ZS (zirconium silicate) is more effective than placebo control (alternative hypothesis) in lowering S-K levels in subjects with S-K between 5.0 - 6.5 mmol/l versus no difference between ZS and…
- Trial name
- NCT01737697
- Testing
- Zirconium silicate (acute phase), Zirconium silicate (subacute phase)
- Where
- 44 sites in United States, Australia
- Volunteers
- 754 people
- Sponsor
- ZS Pharma, Inc.
Hyperkalemia
Reduce Incidence of Pre-Dialysis Hyperkalaemia With Sodium Zirconium Cyclosilicate in Chinese Subjects
The purpose of this study is to evaluate the efficacy and safety of Sodium Zirconium Cyclosilicate (SZC), as well as the appropriateness of the dosing mechanism, in Chinese end-stage renal disease (ESRD) patients on chronic…
- Trial name
- DIALIZE China (NCT04217590)
- Testing
- Sodium Zirconium Cyclosilicate
- Where
- 36 sites in China
- Volunteers
- 134 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
Kidney Failure, Chronic
Relypsa For ED Acute Hyperkalemia Control and Reduction (REDUCE)
The Investigator hypothesize that a single dose of patiromer will lower serum potassium levels in less than 6hrs. Since a dosage of 30g/day for a period of 4 weeks has been studied in at least two multicenter randomized…
- Trial name
- NCT02933450
- Testing
- Patiromer 25.2 g
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Baylor College of Medicine
Hyperkalemia
Patiromer With or Without Food for the Treatment of Hyperkalemia
The purpose of this study is to evaluate the efficacy and safety of patiromer administered once daily (QD) when given with food compared to without food (experimental treatment group) for the treatment of hyperkalemia (high…
- Trial name
- TOURMALINE (NCT02694744)
- Testing
- patiromer
- Where
- 29 sites in United States
- Volunteers
- 114 people
- Sponsor
- Relypsa, Inc.
ESRD, Hyperkalemia
The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia
The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia (potassium greater than 5 milliequivalents per liter) is a non-randomized, crossover study.
- Conditions
- ESRD, Hyperkalemia, End Stage Renal Disease
- Trial name
- NCT03326583
- Testing
- Patiromer
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Dominic Raj
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
Acute Hyperkalemia, Oral Potassium Binders
Comparison of Potassium Binders in the ER
Compare efficacy of 3 oral potassium binders (cation exchange resins) on lowering blood potassium, in hospital patients with acute hyperkalemia.
- Trial name
- KBindER (NCT04585542)
- Testing
- Polyethylene Glycol 3350, Sodium Polystyrene Sulfonate Oral Suspension [SPS], Patiromer
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- University of California, Irvine
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
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
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 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
Safety & Efficacy of Zirconium Silicate Dosed for 28 Days in Hyperkalemia.
It is hypothesized that ZS is more effective than placebo control (alternative hypothesis) in maintaining mean double-blind randomized maintenance phase (DBRMP) Day 8-29 serum potassium levels (3.5 - 5.0 mmol/l, inclusive) among…
- Trial name
- NCT02088073
- Testing
- Sodium zirconium cyclosilicate
- Where
- 46 sites in United States, Australia and 1 more
- Volunteers
- 258 people
- Sponsor
- ZS Pharma, Inc.
Chronic Kidney Disease, Hypertension
Patiromer in the Treatment of Hyperkalemia in Patients With Hypertension and Diabetic Nephropathy (AMETHYST-DN)
This study determined the optimal starting dose of patiromer in treating hyperkalemia in participants with hypertension and diabetic nephropathy who were already receiving ACEI and/or ARB drugs, with or without spironolactone.
- Conditions
- Chronic Kidney Disease, Hypertension, Hyperkalemia
- Trial name
- AMETHYST-DN (NCT01371747)
- Testing
- patiromer, losartan, spironolactone
- Where
- 43 sites in Croatia, Georgia and 3 more
- Volunteers
- 324 people
- Sponsor
- Relypsa, Inc.
Type2 Diabetes, Hyperkalemia
Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Add-On
Patiromer add-on to a mineralocorticoid receptor antagonist (MRA) in patients with Type 2 diabetes mellitus and chronic kidney disease (CKD) will reduce blood pressure and left ventricular (LV) mass to a greater extent compared…
- Trial name
- MAGMAAddOn (NCT03597035)
- Testing
- Spironolactone
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- University Hospitals Cleveland Medical Center