Clinical trials: Hyperkalemia
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.
Chronic Kidney Disease, Hyperkalemia
Dietary Potassium Liberalization in Pre-Dialysis Patients
The study will look at the impact of the potassium content in fruits and vegetables, on serum potassium concentrations in people with Chronic Kidney Disease (CKD) using a randomized crossover design.
- Trial name
- DK-LIB (NCT05090865)
- Testing
- Liberalized dietary potassium via fruits and vegetables, Standard dietary potassium restriction
- Where
- 2 sites in Canada
- Volunteers
- 30 people
- Sponsor
- University of Manitoba
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
Hyperkalaemia
VITALIZE.Use and Effectiveness of Sodium Zirconium Cyclosilicate (LokelmaTM) in the Real-world Setting in Spain
Primary Objective(s) \& Hypothesis(es) 1. To describe the status of kalaemia in patients treated with SZC in the real-world setting at first visit after treatment initiation. 2.
- Trial name
- VITALIZE (NCT06635499)
- Where
- 14 sites in Spain
- Volunteers
- 232 people
- Sponsor
- AstraZeneca
Hyperkalemia
Insulin Dextrose Infusion vs Nebulized Salbutamol vs Combination of Salbutamol and Insulin Dextrose in Acute Hyperkalemia
Hyperkalemia is a common electrolyte disorder, especially among patients with chronic kidney disease, diabetes mellitus, or heart failure.
- Trial name
- InSaKa (NCT04012138)
- Testing
- Salbutamol, Insulin Aspart
- Where
- 16 sites in France
- Volunteers
- 419 people
- Sponsor
- Nantes University Hospital
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
Chronic Kidney Diseases, Heart Failure With Reduced Ejection Fraction
Lokelma for RAAS Maximisation in CKD & Heart Failure.
Background: CKD in patients with heart failure (HF) is common and associated with poor prognosis. Despite evidence of benefit with Renin-Angiotensin-Aldosterone-System inhibitor (RAASi) agents, they are avoided due to fear of…
- Conditions
- Chronic Kidney Diseases, Heart Failure With Reduced Ejection Fraction, Hyperkalemia, ACE Inhibitor Induced Hyperkalaemia
- Trial name
- LIFT (NCT05004363)
- Testing
- Lokelma Oral Product
- Where
- United Kingdom
- Volunteers
- 112 people
- Sponsor
- St George's, University of London
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, 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, Chronic Kidney Disease
Prediction of Hyperkalemia in Dialysis Patients Through Waveform Analysis Using Wearable ECG
This study aims to evaluate whether hyperkalemia, a potentially life-threatening condition in dialysis patients, can be detected early using a wearable single-lead ECG device.
- Trial name
- NCT07054905
- Testing
- HiCardi wearable ECG
- Where
- South Korea
- Volunteers
- 32 people
- Sponsor
- Kyungho Park
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