Clinical trials: 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.
Hyponatremia, Euvolemia
A Study of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia
The study will evaluate the effectiveness and safety of multiple dosing regimens of IV conivaptan in subjects with euvolemic or hypervolemic hyponatremia
- Conditions
- Hyponatremia, Euvolemia, Hypervolemia
- Trial name
- NCT00435591
- Testing
- Conivaptan
- Where
- 18 sites in United States, India and 1 more
- Volunteers
- 121 people
- Sponsor
- Cumberland Pharmaceuticals
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
Mitochondrial Diseases
A Long-term Extension of Study RP103-MITO-001 (NCT02023866) to Assess Cysteamine Bitartrate Delayed-release Capsules (RP103) in Children With Inherited Mitochondrial Disease
A long-term extension study to assess the safety, tolerability and efficacy of cysteamine bitartrate delayed-release capsules (RP103) in children with inherited mitochondrial diseases who previously enrolled into study…
- Trial name
- NCT02473445
- Testing
- Cysteamine Bitartrate
- Where
- 5 sites in United States
- Volunteers
- 22 people
- Sponsor
- Amgen
Secondary Hyperparathyroidism, Renal Insufficiency, Chronic
Effectiveness and Safety of IV Zemplar in Patients on Hemodialysis and With Secondary Hyperparathyroidism Using iPTH/100 as Initial Dose
The purpose of this study is to observe the effectiveness and safety of the use of a low initial dose regime (iPTH/100) in chronic kidney disease patients with secondary hyperparathyroidism (PTH>300pg/mL) and that require…
- Conditions
- Secondary Hyperparathyroidism, Renal Insufficiency, Chronic, Parathyroid Hormone, Hemodialysis
- Trial name
- NCT00891813
- Testing
- Zemplar (paricalcitol)
- Where
- 3 sites in Peru
- Volunteers
- 100 people
- Sponsor
- Abbott
Hyperkalemia
Patiromer With or Without Food for the Treatment of Hyperkalemia
The purpose of this study is to evaluate the efficacy and safety of patiromer administered once daily (QD) when given with food compared to without food (experimental treatment group) for the treatment of hyperkalemia (high…
- Trial name
- TOURMALINE (NCT02694744)
- Testing
- patiromer
- Where
- 29 sites in United States
- Volunteers
- 114 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.
Metabolic Acidosis
Long-term Safety Extension to Study TRCA-301
This study is a 40-week, blinded, placebo-controlled extension of Study TRCA-301 (NCT03317444). Eligible subjects who complete the 12-week treatment period in Study TRCA-301 have the option to participate in this extension study…
- Trial name
- NCT03390842
- Testing
- TRC101
- Where
- 29 sites in United States, Bulgaria and 5 more
- Volunteers
- 196 people
- Sponsor
- Tricida, 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
Hyponatremia, Syndrome of Inappropriate ADH (SIADH) Secretion
An Observational Study to Describe the Adherence to the SEOM Algorithm for the Treatment of Hyponatraemia in Spain
In 2014, the Spanish Sociedad Española de Oncología Médica (SEOM) algorithm for the treatment of hyponatraemia secondary to to syndrome of inappropriate antidiuretic hormone (SIADH) in oncology patients was developed.
- Trial name
- ALGA (NCT02548845)
- Where
- 4 sites in Spain
- Volunteers
- 70 people
- Sponsor
- Otsuka Pharmaceutical Europe Ltd
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
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.
Vestibular Disorder
Testing an Intraoral Electronic Balance Aid for Vestibular Imbalance
The human body uses vestibular feedback in coordination with visual and somatosensory information to maintain balance and posture.
- Trial name
- NCT02735096
- Testing
- EquiCue (Intraoral Electronic Balance Aid)
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Innervo Technology LLC
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
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.
Metabolic Acidosis
Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease
This is a multicenter, double-blind, placebo-controlled, parallel-design study. The study will enroll approximately 210 adult male and female subjects with stage 3 or 4 chronic kidney disease and metabolic acidosis.
- Trial name
- NCT03317444
- Testing
- TRC101
- Where
- 44 sites in United States, Bulgaria and 6 more
- Volunteers
- 217 people
- Sponsor
- Tricida, Inc.
Hyponatremia
Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia
The study is designed to assess the efficacy and safety of multiple infusions of conivaptan in subjects with euvolemic or hypervolemic hyponatremia
- Trial name
- NCT00478192
- Testing
- Conivaptan
- Where
- 26 sites in United States, India
- Volunteers
- 50 people
- Sponsor
- Cumberland Pharmaceuticals
Hyperkalemia
Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND)
The purpose of this study is to assess the effects of patiromer compared with placebo on serum K+ in HF patients.
- Trial name
- DIAMOND (NCT03888066)
- Testing
- Patiromer
- Where
- 415 sites in United States, Argentina and 19 more
- Volunteers
- 1,195 people
- Sponsor
- Vifor Pharma, Inc.
DiGeorge Anomaly, DiGeorge Syndrome
Thymus Transplantation Dose in DiGeorge #932
One purpose of this study is to determine whether the amount of cultured thymus tissue implanted into DiGeorge anomaly infants has any effect on the immune outcome.
- Conditions
- DiGeorge Anomaly, DiGeorge Syndrome, Complete DiGeorge Anomaly, Complete DiGeorge Syndrome
- Trial name
- NCT00576836
- Testing
- Cultured Thymus Tissue Implantation (CTTI), Cultured Thymus Tissue Implantation with Parathyroid Transplantation
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Sumitomo Pharma Switzerland GmbH