Clinical trials: Electrolyte Disturbance
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
A Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ZS) Among Patients With S-K ≥5.8
The study is designed to determine if ZS 10g administered up to three times over 10h added to insulin and glucose in patients presenting with hyperkalemia will prove tolerable and efficacious.
- Trial name
- ENERGIZE (NCT03337477)
- Testing
- Sodium Zirconium Cyclosilicate(ZS), Insulin, Glucose
- Where
- 25 sites in United States, Denmark and 2 more
- Volunteers
- 70 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.
Hyperparathyroidism, Secondary
Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG 416) for the treatment of SHPT in adults with CKD on hemodialysis.
- Trial name
- NCT01785875
- Testing
- Etelcalcetide
- Where
- 208 sites in United States, Australia and 15 more
- Volunteers
- 891 people
- Sponsor
- Amgen
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
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.
Sepsis, Gastroenteritis
Utility of Ultrasound Assessment of the Inferior Vena Cava in Patients With Sepsis and Dehydration
Conduct a randomized, controlled trial looking at how the use of ultrasound analyzing the inferior vena cava impacts the management and outcomes of pediatric emergency department patients undergoing evaluation and treatment of…
- Conditions
- Sepsis, Gastroenteritis, Dehydration
- Trial name
- NCT02568189
- Testing
- SonoSite Maxx Series Ultrasound System
- Where
- United States
- Volunteers
- 112 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Hyperparathyroidism, Secondary
Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide
This is a multicenter, multiple-dose, single-arm, open-label study to assess the impact on serum corrected calcium levels when switching patients from cinacalcet to etelcalcetide (AMG 416).
- Trial name
- NCT01932970
- Testing
- Etelcalcetide
- Where
- 40 sites in United States
- Volunteers
- 158 people
- Sponsor
- Amgen
Secondary Hyperparathyroidism, Chronic Kidney Disease
Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)
Secondary Hyperparathyroidism (SHPT) occurs in many patients with kidney disease and leads to bone disease. Active forms of vitamin D, calcitriol and paricalcitol, treat SHPT, but may have different effects on blood calcium.
- Trial name
- PACE (NCT00823303)
- Testing
- Paricalcitol, Calcitriol
- Where
- 4 sites in United States
- Volunteers
- 110 people
- Sponsor
- Washington University School of Medicine
Hyponatremia, Syndrome of Inappropriate ADH (SIADH) Secretion
An Observational Study on Real-world Use and Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to SIADH
This is a retrospective chart review non-interventional study designed to collect real world data on the use and outcomes of tolvaptan for the treatment of patients with hyponatraemia secondary to syndrome of inappropriate…
- Trial name
- SAMPLE (NCT02545101)
- Where
- 7 sites in Germany, Spain
- Volunteers
- 100 people
- Sponsor
- Otsuka Pharmaceutical Europe Ltd
Gastroenteritis, Dehydration
Rotavirus Burden and Genotypes in a Sentinel Hospital Surveillance System in Lebanon
This study aims to determine the contribution of rotavirus infection as a cause of gastroenteritis requiring hospitalization in children younger than 5 years of age.
- Trial name
- NCT01321216
- Where
- 4 sites in Lebanon
- Volunteers
- 1,555 people
- Sponsor
- American University of Beirut Medical Center
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
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
Hyponatremia
Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia
The purpose of this study is to determine if isotonic solutions reduce the risk of hospital acquired hyponatremia compared with hypotonic solutions.
- Trial name
- NCT01909336
- Testing
- 0.3% Saline in 3.3% dextrose, 0.45% Saline in 5% dextrose, 0.9% Saline in 5% dextrose
- Volunteers
- 161 people, healthy volunteers welcome
- Sponsor
- Instituto Tecnologico y de Estudios Superiores de Monterey
Dehydration, Cardiac Output
Descriptive Study of Cardiac Output During Rehydration With Recombinant Human Hyaluronidase in Pediatrics
The purpose of this study is to non-invasively study the reflective changes in cardiac output as response to fluid therapy in the pediatric moderate hypovolemia/dehydrated pediatric patients using sub-q rehydration using Hylenex…
- Conditions
- Dehydration, Cardiac Output, Pediatrics
- Trial name
- Hylenex (NCT01139294)
- Testing
- Hylenex
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University Medical Center
Mild Dehydration
The Effect of Acute Mild Dehydration on Blood Pressure Control
The goal of this project is determine how acute mild dehydration impacts blood pressure control at rest and during static exercise.
- Trial name
- NCT03560869
- Testing
- Normal hydration, Dehydration
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- University of Delaware
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.
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.
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.
Electrolyte Imbalance, Hyponatremia
V2 Receptor Effects on Fluid Regulation and Performance
This primary aim of this study was to critically assess whether or not sweat water content and sodium concentration were acutely regulated by dynamic changes in antidiuretic hormone (arginine vasopressin or AVP) acting on the…
- Conditions
- Electrolyte Imbalance, Hyponatremia, Hypernatremia
- Trial name
- NCT02084797
- Testing
- V2R (Vasopressin 2 receptor)
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Oakland University