Clinical trials: Hyperkalemia, active
Hyperkalemia
A Two-Part, Open-Label, Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia
This clinical trial is an open-label, consisting of 2 phases, corrective phase (CP) and a maintenance phase (MP). The corrective phase aims to correct hyperkalemia within 24 to 72 hours, the maintenance phase aims to maintain the…
- Trial name
- NCT07881965
- Testing
- WS016
- Where
- 50 sites in China
- Volunteers
- 300 people
- Sponsor
- Waterstone Pharmaceutical (Wuhan) Co., LTD.
Chronic Kidney Disease, Type 2 Diabetes
Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)
The goal of this clinical trial is to learn if starting four kidney disease medicines quickly and together (a rapid treatment approach) is safe and works well in people with type 2 diabetes and chronic kidney disease.
- Trial name
- RAPID-CKD (NCT07547878)
- Testing
- Finerenone, Semaglutide, Lotensin
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Baylor Research Institute
Hyperkalemia, Chronic Kidney Disease (Stages 4 and 5)
Safety of a Healthy Plant-based Diet With Higher Potassium Content, Compared to a Healthy Plant-based Diet With Limited Potassium Content in Patients With Chronic Kidney Disease: A Pilot Study
For many years, people with moderate to advanced chronic kidney disease (CKD) have been advised to limit their intake of potassium, a mineral found in many foods such as fruit, vegetables, legumes, whole grains, and nuts.
- Trial name
- SAFE-K (NCT07494266)
- Testing
- Healthy plant-based diet (healthy-PBD), Potassium-restricted plant-based diet
- Where
- Sweden
- Volunteers
- 30 people
- Sponsor
- Karolinska Institutet
Hyperkalemia
Effect of Patiromer in Children Under 12 Years of Age With High Blood Potassium Levels
A study to evaluate the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia.
- Trial name
- EMERALD2 (NCT05766839)
- Testing
- Patiromer
- Where
- 37 sites in United States, Australia and 13 more
- Volunteers
- 36 people
- Sponsor
- Vifor Pharma, Inc.
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
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
Acute Kidney Injury, Renal Insufficiency,Chronic
Finerenone for AKI: a Multicenter, Randomized, Placebo-Controlled Feasibility Pilot Trial
This study is testing whether finerenone, when compared to placebo, is a tolerable and safe intervention when administered in patients with acute kidney injury (AKI).
- Conditions
- Acute Kidney Injury, Renal Insufficiency,Chronic, Kidney Diseases
- Trial name
- FiPAKI (NCT07775482)
- Testing
- Finerenone (BAY94-8862 ) 10 mg
- Where
- Canada
- Volunteers
- 72 people
- Sponsor
- Jean-Maxime Côté
End Stage Kidney Disease (ESKD), Hemodialysis
Liberalizing Potassium Restrictions in Patients Receiving Hemodialysis
People with end-stage kidney disease who receive hemodialysis are often told to strictly limit foods high in potassium, such as fruits, vegetables, legumes, nuts, and whole grains.
- Conditions
- End Stage Kidney Disease (ESKD), Hemodialysis, Diet Intervention, Hyperkalemia
- Trial name
- LIBERATE-K HD (NCT07772856)
- Testing
- Liberalized Potassium Diet, Low Potassium Diet
- Where
- Canada
- Volunteers
- 148 people
- Sponsor
- University of Ontario Institute of Technology
Hyperkalaemia
An Open-label Study to Assess Safety and Efficacy of SZC in Paediatric Patients With Hyperkalaemia
Sodium zirconium cyclosilicate has been shown to be effective and safe in adults for the treatment of hyperkalaemia, and therefore it is expected to be beneficial in children.
- Trial name
- PEDZ-K (NCT03813407)
- Testing
- Sodium Zirconium Cyclosilicate (SZC) Reduced Dose Level, Sodium Zirconium Cyclosilicate (SZC) Dose Level 1 (DL1), Sodium Zirconium Cyclosilicate (SZC) Dose Level 2 (DL2)
- Where
- 70 sites in United States, Brazil and 11 more
- Volunteers
- 140 people
- Sponsor
- AstraZeneca
Renal Insufficiency, Chronic, Potassium Depletion
Potassium Supplementation in CKD
The current high-sodium, low-potassium diet contributes to the high prevalence of high blood pressure (hypertension). Indeed, the anti-hypertensive effects of potassium supplementation are well-established.
- Conditions
- Renal Insufficiency, Chronic, Potassium Depletion, Hypertension, Hyperkalemia
- Trial name
- K+ in CKD (NCT03253172)
- Testing
- Potassium Chloride, Potassium Citrate
- Where
- 4 sites in Netherlands
- Volunteers
- 532 people
- Sponsor
- Erasmus Medical Center
Heart Failure, Diabetic Kidney Disease
Spironolactone Alternate Dosing vs Finerenone in Elevated Potassium - K Safety Study
This study evaluates the safety of finerenone compared with alternate-day spironolactone in patients with heart failure and diabetic kidney disease at increased risk of hyperkalemia.
- Conditions
- Heart Failure, Diabetic Kidney Disease, Hyperkalemia
- Trial name
- SAFE-K (NCT07523867)
- Testing
- Finerenone, Spironolactone (drug)
- Volunteers
- 60 people
- Sponsor
- Hospital de Messejana Dr. Carlos Alberto Studart Gomes
Hyperkalemia
Lower vs. Standard Insulin-Dextrose Doses for Treating Mild to Moderate Hyperkalemia in the Emergency Department
This clinical trial aims to evaluate the safety and efficacy of a lower dose insulin compared to the conventional dose for treating mild to moderate hyperkalemia, a condition characterized by elevated serum potassium levels below…
- Trial name
- IDK+ (NCT06724991)
- Testing
- Lower Dose Therapy, Conventional Dose Therapy
- Where
- Malaysia
- Volunteers
- 50 people
- Sponsor
- University of Malaya
Dysequilibrium Syndrome, ESRD
Adding Urea to the Final Dialysis Fluid
At times patients with advanced renal failure present with severe hyperkalemia or acidosis and very high serum blood urea nitrogen (BUN) concentrations.
- Conditions
- Dysequilibrium Syndrome, ESRD, Hyperkalemia, Metabolic Acidosis
- Trial name
- Urea dialysate (NCT06366230)
- Testing
- Urea in the dialysate
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of California, San Francisco
Chronic Kidney Disease
Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD
What is this study about? This clinical trial is designed to learn how potassium from different types of food affects blood potassium levels and overall health in people with chronic kidney disease (CKD, stages 3B-5).
- Trial name
- K-HANDLE CKD (NCT06920914)
- Testing
- Low-potassium, ultra-processed diet, Low-potassium, minimally processed diet, Normal potassium-rich, minimally processed diet
- Volunteers
- 48 people
- Sponsor
- University of Alberta
Hyperkalaemia
AI-Enabled ECG Stratification and Timing of Potassium-Lowering Therapy in Patients With Hyperkalemia: A Target Trial Emulation Study
Hyperkalemia is a common and potentially life-threatening electrolyte disorder, yet there is limited evidence guiding the optimal timing of potassium-lowering therapy in routine clinical practice.
- Trial name
- AIDE-K (NCT07307729)
- Testing
- Timely treatment, Delayed treatment
- Volunteers
- 5,000 people
- Sponsor
- National Defense Medical Center, Taiwan
Chronic Kidney Diseases, Hyperkalemia
Potassium Correction for RAAS Optimization in Chronic Kidney Disease
The goal of this placebo-controlled, double-blinded cross-over trial is to test whether patiromer, compared with placebo, better enables up-titration of RAAS-blocker treatment in patients with chronic kidney disease stage 3b/4.
- Conditions
- Chronic Kidney Diseases, Hyperkalemia, Hypertension
- Trial name
- PROMISE (NCT06256991)
- Testing
- Patiromer 8400 MG [Veltassa]
- Where
- Netherlands
- Volunteers
- 44 people
- Sponsor
- University Medical Center Groningen
Hyperkalemia, Diminished Renal Excretion
Evidence for Potassium Restriction in Hemodialysis
EvoKe-HD is a pilot randomized controlled trial to assess the feasibility and potential for efficacy of a novel dietary approach to hyperkalemia.
- Trial name
- EvoKe-HD (NCT06120608)
- Testing
- Novel dietary approach focused on restricting the intake of highly bioavailable potassium, Traditional approach
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
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.
Hyperkalemia, Chronic Kidney Disease (Stage 3-4)
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
The goal of this observational pilot study is to evaluate the investigational AK+ Guard™ software as a medical device (SaMD) for detection of moderate to severe hyperkalemia (serum potassium (K+) ≥ 6.5 mmol/L) in adults with…
- Trial name
- NCT07210021
- Testing
- AK+ Guard™ ECG Application
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- AccurKardia, Inc.
Chronic Kidney Disease (Stages 3b-5)
Monitoring Hyperkalemia Using Point-of-care AI-enabled ECG Device Among Patients With Chronic Kidney Disease Stages 3b-5
The clinical trial will be conducted in a real-world outpatients setting with the goal of learning if monitoring serum potassium frequently among patients with moderate-to-advanced stages of chronic kidney disease leading to…
- Trial name
- POCKET (NCT06901960)
- Testing
- A mobile artificial intelligence-enhanced electrocardiogram device estimating plasma potassium categories (<5 mmol/L, 5 - <5.5 mmol/L, 5.5 - <6.0 mmol/L and ≥ 6.0 mmol/L)
- Where
- 3 sites in China
- Volunteers
- 1,066 people
- Sponsor
- Peking University First Hospital