Clinical trials: Hyperkalaemia
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
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 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
Hyperkalemia
Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia.
Subjects who completed the Double-blind Randomized Maintenance Phase (DBRMP) Study Day 29 visit in ZS-004 (NCT 02088073) and have an i-STAT potassium value that is 3.5 to 6.2 mmol/l inclusive or who discontinued during ZS-004 due…
- Trial name
- NCT02107092
- Testing
- Sodium Zirconium Cyclosilicate
- Where
- 49 sites in United States, Australia and 1 more
- Volunteers
- 123 people
- Sponsor
- ZS Pharma, Inc.
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.
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.
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
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.
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.
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
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
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
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.
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
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
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
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
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 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
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.