Clinical trials: Hyperkalemia
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
Renal Insufficiency, Chronic, Hyperkalemia
A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia
The purpose of this study is to evaluate the effect of Sodium Zirconium Cyclosilicate (SZC), as adjunct to ACEi/ARB therapy (lisinopril or valsartan), on slowing CKD progression (assessed as the reduction in participant's…
- Trial name
- STABILIZE-CKD (NCT05056727)
- Testing
- Sodium Zirconium Cyclosilicate (SZC), Lisinopril, Valsartan
- Where
- 276 sites in United States, Argentina and 19 more
- Volunteers
- 1,112 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
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, End Stage Renal Disease
Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients
The purpose of this study is to determine whether once-daily dosing of patiromer will reduce the frequency of hyperkalemic episodes in ESRD (end stage renal disease) study participants who receive conventional hemodialysis (HD).
- Trial name
- NCT03781089
- Testing
- Patiromer Oral Powder Product
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Duke University
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
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
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
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
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
Hyperkalemia
Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND)
The purpose of this study is to assess the effects of patiromer compared with placebo on serum K+ in HF patients.
- Trial name
- DIAMOND (NCT03888066)
- Testing
- Patiromer
- Where
- 415 sites in United States, Argentina and 19 more
- Volunteers
- 1,195 people
- Sponsor
- Vifor Pharma, Inc.
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
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.
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
Chronic Kidney Diseases, Hyperkalemia
Use of Patiromer to Transition Chronic Kidney Disease Patients With Hyperkalemia to a Plant-rich Diet.
The purpose of this proof-of-concept controlled-feeding study is to determine whether patiromer (Veltassa®, Relypsa, Inc., Redwood City, CA) can be used to maintain normal serum potassium concentrations in chronic kidney disease…
- Trial name
- NCT03183778
- Testing
- Patiromer, Research Diet Menu
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- NYU Langone Health
Heart Failure
Potassium Reduction Initiative to Optimize RAAS Inhibition Therapy With Sodium Zirconium Cyclosilicate in Heart Failure
This is an international, multicentre, parallel-group, randomised, double-blind, placebo controlled, phase II study to evaluate the benefits and risks of using sodium zirconium cyclosilicate (ZS) to initiate and intensify renin…
- Trial name
- PRIORITIZE HF (NCT03532009)
- Testing
- Sodium Zirconium Cyclosilicate
- Where
- 76 sites in United States, Brazil and 7 more
- Volunteers
- 182 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.
Chronic Kidney Disease (CKD), Hyperkalemia (HK)
A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL)
The purpose of this study was to evaluate the efficacy and safety of patiromer (investigational drug) in the treatment of hyperkalemia (high serum potassium).
- Trial name
- OPAL (NCT01810939)
- Testing
- Patiromer
- Where
- 58 sites in United States, Croatia and 8 more
- Volunteers
- 243 people
- Sponsor
- Relypsa, Inc.