Polycystic Kidney Disease Treatments
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Generic Name
Tolvaptan
Brand Names
Samsca, Jynarque
FDA approval date: May 19, 2009
Classification: Vasopressin V2 Receptor Antagonist
Form: Tablet, Kit
What is Samsca (Tolvaptan)?
Tolvaptan tablets are indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia , including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone . Limitations of Use : Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with tolvaptan tablets. It has not been established that raising serum sodium with tolvaptan tablets provides a symptomatic benefit to patients. Tolvaptan tablets are a selective vasopressin V 2 -receptor antagonist indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia , including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone Limitations of Use: Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with tolvaptan tablets It has not been established that tolvaptan tablets provides a symptomatic benefit to patients
Approved To Treat
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Related Clinical Trials
STOP-PKD: SGLT2-inhibition to Improve Prognosis in Polycystic Kidney Disease
Summary: Autosomal dominant polycystic kidney disease is the most common genetic cause of kidney failure. The only approved treatment for ADPKD - tolvaptan - is limited in its use by massive therapy-associated polyuria. This trial tests if the SGLT2-inhibitor dapagliflozin slows down the loss of kidney function in ADPKD.
A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 Days to Less Than 18 Years of Age With Autosomal Recessive Polycystic Kidney Disease (ARPKD)
Summary: To evaluate the safety of tolvaptan in pediatric subjects with ARPKD
Samsca Post-marketing General Drug Use-results Survey in Patients with Hyponatremia in Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) in Japan
Summary: The purpose of this study is to confirm the safety of tolvaptan in patients with hyponatremia in syndrome of inappropriate antidiuretic hormone secretion (SIADH) in Japan