Clinical trials: Hyperkalemia
Hyperkalemia
A Study to Evaluate the Safety and Efficacy of WS016 in Patients With Hyperkalemia.
The goal of this clinical trial is to evaluate the efficacy of different doses of WS016(3g, 6g and 12g) orally administered three times a day for 48 hours (acute treatment phase) vs placebo in the treatment of hyperkalemia, and…
- Trial name
- NCT06277128
- Testing
- WS016 3g, WS016 6g, WS016 12g
- Where
- 26 sites in China
- Volunteers
- 140 people
- Sponsor
- Waterstone Pharmaceutical (Wuhan) Co., LTD.
Hyperkalemia
Hyperkalemia Quality Improvement Program (HK-QIP) Study
This is a prospective, multi-center, single-arm study to evaluate the impact of implementation of guideline determined medical therapy (GDMT) for quality control improvement in non-dialysis chronic kidney disease (CKD-ND)…
- Trial name
- HK-QIP (NCT06884267)
- Testing
- standard hyperkalemia management implementation
- Where
- 49 sites in China
- Volunteers
- 1,000 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
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.
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
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.
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
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
A Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia
This phase 2, single-blind, placebo-controlled study will evaluate the onset-of-action, safety, and efficacy of RDX227675 for the treatment of hyperkalemia.
- Trial name
- NCT03018067
- Testing
- RDX227675
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Ardelyx
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.
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 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.
Heart Failure
Evaluation of Patiromer Titration in Heart Failure Patients With Chronic Kidney Disease
The purpose of this study was to evaluate the feasibility of individualized titration of patiromer according to serum potassium.
- Trial name
- NCT01130597
- Testing
- patiromer, spironolactone
- Where
- 13 sites in Georgia, Slovenia
- Volunteers
- 63 people
- Sponsor
- Relypsa, Inc.
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
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
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
A Multicenter, Prospective, Non-interventional Cohort Study to Evaluate the Safety and Treatment Pattern of Sodium Zirconium Cyclosilicate for Hyperkalaemia Management in Real World Practice in China
The study is a multi-center prospective (primary data) non-interventional cohort study which enrolls 1500 patients including new and ongoing users on SZC at Study Enrollment Day in real-world clinical practice.
- Trial name
- ACTUALIZE (NCT05271266)
- Where
- 27 sites in China
- Volunteers
- 1,000 people
- Sponsor
- AstraZeneca
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
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