Clinical trials: Hyperkalemia
Hyperkalemia, Chronic Kidney Disease
Safety & Efficacy of Zirconium Silicate in Chronic Kidney Disease or Moderate Kidney Dysfunction With Mild Hyperkalemia
It is hypothesized that zirconium silicate is safe and well tolerated and more effective than placebo (alternative hypothesis) in lowering serum potassium levels in subjects with serum potassium between 5 - 6.0 mmol/l versus no…
- Conditions
- Hyperkalemia, Chronic Kidney Disease, Kidney Dysfunction
- Trial name
- NCT01493024
- Testing
- Zirconium silicate (ZS)
- Where
- 9 sites in United States
- Volunteers
- 90 people
- Sponsor
- ZS Pharma, Inc.
Hyperkalemia
An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Participants on Hemodialysis
This study assessed the pharmacodynamic effects of patiromer on serum potassium in participants on hemodialysis.
- Trial name
- NCT02033317
- Testing
- patiromer
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Relypsa, Inc.
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
CKD, Diabetes Mellitus, Type 2
The ORTIZ Study: Optimising RASi Therapy With SZC
The hypothesis is that 3 months' treatment with SZC versus placebo will enable RASi (Irbesartan) maximisation in a cohort of patients with diabetic kidney disease.
- Conditions
- CKD, Diabetes Mellitus, Type 2, Hyperkalemia
- Trial name
- ORTIZ (NCT04983979)
- Testing
- Sodium Zirconium Cyclosilicate
- Where
- United Kingdom
- Volunteers
- 18 people
- Sponsor
- Barts & The London NHS Trust
Hyperkalemia
Open-label Safety and Efficacy of Sodium Zirconium Cyclosilicate for up to 12 Months
The Open-Label Maintenance Study contains an Acute Phase, in which subjects will be dosed with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a long-term Maintenance Phase.
- Trial name
- NCT02163499
- Testing
- Sodium Zirconium Cyclosilicate
- Where
- 50 sites in United States, Australia and 5 more
- Volunteers
- 751 people
- Sponsor
- ZS Pharma, Inc.
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
POtassium and Cardiac Rhythm Trends in MaintENance HemoDialysis: A Multicenter, Prospective, Observational Study
This study assesses serum potassium and cardiac rhythm trends in subjects with end stage renal disease (ESRD) who are on 3 times weekly maintenance hemodialysis for at least 60 days.
- Trial name
- PORTEND (NCT02609841)
- Testing
- Cardiac rhythm remote monitoring system
- Where
- 9 sites in United States
- Volunteers
- 240 people
- Sponsor
- ZS Pharma, Inc.
Hyperkalemia
A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia.
To evaluate the efficacy of two different doses (5 and 10 g) of ZS orally administered once daily (qd) vs placebo in maintaining normokalemia in initially hyperkalemic patients having achieved normokalemia following 24 or 48…
- Trial name
- HARMONIZE Asia (NCT03528681)
- Testing
- Sodium Zirconium Cyclosilicate 5g, Sodium Zirconium Cyclosilicate 10g
- Where
- 66 sites in China, India
- Volunteers
- 270 people
- Sponsor
- AstraZeneca
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.
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
Hyperkalemia
A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia
To evaluate the efficacy of two different doses (5 and 10 g) of ZS orally administered once daily (qd) vs placebo in maintaining normokalemia in initially hyperkalemic patients having achieved normokalemia following two days of…
- Trial name
- HARMONIZE GL (NCT02875834)
- Testing
- Sodium Zirconium Cyclosilicate (ZS) 10g, Sodium Zirconium Cyclosilicate (ZS) 5g
- Where
- 45 sites in Japan, Russia and 2 more
- Volunteers
- 267 people
- Sponsor
- AstraZeneca
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.
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, 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.
Kidney Disease, Nephropathy
VA NEPHRON-D: Diabetes iN Nephropathy Study
Diabetes is the leading cause of end-stage renal disease (ESRD) in the United States. The overall rate of ESRD secondary to diabetes has risen 68% since 1992.
- Conditions
- Kidney Disease, Nephropathy, Type 2 Diabetes
- Trial name
- VA NEPHRON-D (NCT00555217)
- Testing
- losartan, lisinopril
- Where
- 31 sites in United States, Puerto Rico
- Volunteers
- 1,448 people
- Sponsor
- US Department of Veterans Affairs
Hyperkalemia
A Study to Test Whether ZS (Sodium Zirconium Cyclosilicate) Can Reduce the Incidence of Increased Blood Potassium Levels Among Dialized Patients.
The purpose of this study is to evaluate the efficacy of ZS in the treatment of hyperkalemia in patients on hemodialysis.
- Trial name
- DIALIZE (NCT03303521)
- Testing
- Sodium Zirconium Cyclosilicate (ZS)
- Where
- 53 sites in United States, Japan and 2 more
- Volunteers
- 196 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.
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, Heart Failure
Evaluation of Patiromer in Heart Failure Patients
The purpose of this study was to assess the effects of patiromer on serum potassium participants with heart failure. This study also assessed the safety and tolerability of patiromer in participants with heart failure.
- Trial name
- PEARL-HF (NCT00868439)
- Testing
- patiromer
- Where
- 33 sites in United States, Czechia and 5 more
- Volunteers
- 120 people
- Sponsor
- Relypsa, Inc.