Clinical trials: Sodium Imbalance
Hyponatremia
Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia
The purpose of this trial was to demonstrate that tolvaptan effectively and safely increases and maintains serum sodium concentrations in children and adolescent participants with euvolemic or hypervolemic hyponatremia.
- Trial name
- NCT02012959
- Testing
- Tolvaptan
- Where
- 7 sites in United States, Italy and 1 more
- Volunteers
- 9 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Empaglifozin, Physiological Effects of Drugs
Sodium-glucose Co Transporter 2 (sGLT2) Inhibitor and Endogenous Ketone Production
Background: The drug empagliflozin treats diabetes. It lowers blood sugar by increasing glucose the kidneys excrete. This increases levels of ketones formed in the blood.
- Conditions
- Empaglifozin, Physiological Effects of Drugs, Hypoglycemic Agents, Sodium-Glucose Transporter 2 Inhibitors
- Trial name
- NCT03852901
- Testing
- empagliflozin (Jardiance) 25 mg
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- National Institute on Aging (NIA)
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.
Hyponatremia
A Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous Conivaptan (Vaprisol®) in Pediatric Subjects With Euvolemic or Hypervolemic Hyponatremia
The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of intravenous conivaptan in pediatric subjects with abnormally low concentration of sodium in blood.
- Trial name
- NCT01451411
- Testing
- Conivaptan hydrochloride
- Where
- 3 sites in United States, Colombia
- Volunteers
- 4 people
- Sponsor
- Cumberland Pharmaceuticals
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
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
Chronic Kidney Disease, Metabolic Acidosis
Alkali Therapy in Chronic Kidney Disease
Kidney disease is a common medical condition. Individuals with kidney disease develop a build-up of acid in their blood. This acid can affect their muscles, bones, glucose metabolism and kidneys.
- Trial name
- NCT01452412
- Testing
- Sodium bicarbonate
- Where
- 2 sites in United States
- Volunteers
- 149 people
- Sponsor
- Albert Einstein College of Medicine
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
Hyperkalaemia, Heart Failure With Reduced Ejection Fraction
Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients With Symptomatic HFrEF Receiving Spironolactone
The main objective of this study is to evaluate the efficacy of SZC as compared with placebo in keeping potassium levels within the normal range (3.5-5.0 mEq/L) while on spironolactone ≥25 mg daily without assistance of rescue…
- Trial name
- REALIZE-K (NCT04676646)
- Testing
- Sodium zirconium cyclosilicate, Spironolactone
- Where
- 89 sites in United States, Brazil and 6 more
- Volunteers
- 366 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
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
Hyponatremia, Premature
Early Sodium Intake in Preterm Newborns
Hyponatremia is a common complication among preterm infants, renal losses of sodium contribute to the development of hyponatremia in preterm newborns. Sodium imbalances impact in newborns outcome.
- Trial name
- NCT04035564
- Testing
- Sodium < 1mEq/kg/day, Sodium 5mEq/kg/day
- Where
- Mexico
- Volunteers
- 52 people
- Sponsor
- Hospital del Niño "Dr. Federico Gomez Santos"
Advanced Cancers
Tolvaptan in Hyponatremic Cancer Patients
The goal of this clinical research study is to learn if tolvaptan can help raise salt (sodium) levels in the cancer patients' blood by removing extra body water as urine.
- Trial name
- NCT01199198
- Testing
- Tolvaptan
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- M.D. Anderson Cancer Center
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
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
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
Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)
The purpose of this study is to evaluate the effect of Sodium Zirconium Cyclosilicate (SZC) on arrhythmia-related cardiovascular outcomes in participants on chronic hemodialysis with recurrent hyperkalemia.
- Trial name
- NCT04847232
- Testing
- Sodium Zirconium Cyclosilicate (SZC)
- Where
- 340 sites in United States, Argentina and 24 more
- Volunteers
- 2,690 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.
Hyperkalemia
Open-label Safety of Sodium Zirconium Cyclosilicate for up to 12 Months in Japanese Subjects With Hyperkalemia
The Open-Label Maintenance Study contains an Correction Phase, in which subjects will be dosed with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a 12-month long-term Maintenance Phase.
- Trial name
- NCT03172702
- Testing
- Zirconium Cyclosilicate
- Where
- 42 sites in Japan
- Volunteers
- 150 people
- Sponsor
- AstraZeneca
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