Tolvaptan drug kidney study

Tolvaptan in Patients with Autosomal Dominant Polycystic ...

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Torres VE, Meijer E, Bae KT, et al. Rationale and design of the TEMPO (Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and its Outcomes) 3/4 study. Am J ...

Tolvaptan in Patients with Autosomal Dominant Polycystic ...

Tolvaptan - National Institutes of Health

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3/24/2014 · A 44 year old woman with autosomal dominant polycystic kidney disease (ADPKD) participating in an experimental study of tolvaptan was found to have serum enzyme elevations at a routine 3 month study visit. She reported having mild and transient nausea and abdominal pain during the previous several weeks, but denied jaundice or dark urine.

Tolvaptan - National Institutes of Health

Tolvaptan in Later-Stage Autosomal Dominant Polycystic ...

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In the Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes (TEMPO) 3:4 trial, which involved patients with early ADPKD (estimated ...

Tolvaptan in Later-Stage Autosomal Dominant Polycystic ...

Tolvaptan (Professional Patient Advice) - Drugs.com

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11/26/2018 · Because of the risk of hepatotoxicity, tolvaptan (Samsca) should not be used for autosomal dominant polycystic kidney disease (ADPKD) outside of the FDA-approved REMS. Risk of serious liver injury (Jynarque): Tolvaptan (Jynarque) can cause serious and potentially fatal liver injury.

Tolvaptan (Professional Patient Advice) - Drugs.com

Tolvaptan in Patients with Autosomal Dominant Polycystic ...

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12/20/2012 · Autosomal dominant polycystic kidney disease (ADPKD) is the most common monogenic kidney disease and the fourth leading cause of end-stage kidney disease in adults worldwide. 1,2 It results in the progressive development of kidney cysts, kidney pain, hypertension, and, ultimately, kidney failure. Effective treatment for ADPKD has been lacking.

Tolvaptan in Patients with Autosomal Dominant Polycystic ...

Open-Label Tolvaptan Study in Subjects With ADPKD - Full ...

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10/5/2010 · Open-Label Tolvaptan Study in Subjects With ADPKD (TEMPO 4/4) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. ... Autosomal Dominant Polycystic Kidney Disease (ADPKD) Drug: Tolvaptan: Phase 3: Study ...

Open-Label Tolvaptan Study in Subjects With ADPKD - Full ...

FDA Approval of Tolvaptan for PKD: Breakthrough Therapy vs ...

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In April 2018, the U.S. Food and Drug Administration (FDA) approved the use of tolvaptan for the treatment of autosomal dominant polycystic kidney disease (PKD), allowing the United States to join most of the rest of the world in having the ability to deploy the first disease-specific therapy for PKD.

FDA Approval of Tolvaptan for PKD: Breakthrough Therapy vs ...

Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal ...

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1/30/2007 · Otsuka Pharmaceutical Development & Commercialization, Inc. This study evaluated whether or not tolvaptan is potentially beneficial, while maintaining an adequate safety profile, by reducing the rate of total kidney volume increase, while impacting the onset, severity, and progression of other ...

Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal ...

Clinical Pattern of Tolvaptan-Associated Liver Injury in ...

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7/19/2015 · In TEMPO 3:4, 1445 subjects were randomized 2:1 (tolvaptan vs. placebo) and 1441 had post-baseline assessments of hepatic injury. Sixteen patients on tolvaptan and one on placebo had significant aminotransferase elevations judged to be at least probably related to study drug. No association with dose or systemic exposure was found.

Clinical Pattern of Tolvaptan-Associated Liver Injury in ...

FDA Drug Safety Communication: FDA limits duration and ...

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The U.S. Food and Drug Administration (FDA) has determined that the drug Samsca (tolvaptan) should not be used for longer than 30 days and should not be used in patients with underlying liver ...

FDA Drug Safety Communication: FDA limits duration and ...

Tolvaptan - Wikipedia

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Tolvaptan (trade names Samsca, Jinarc, and others) is an aquaretic drug that functions as a selective, competitive vasopressin receptor 2 (V2) antagonist used to treat hyponatremia (low blood sodium levels) associated with congestive heart failure, cirrhosis, and the syndrome of inappropriate antidiuretic hormone (SIADH).

Tolvaptan - Wikipedia

Tolvaptan and Kidney Pain in Patients With Autosomal ...

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Background. Kidney pain is a common complication in patients with autosomal dominant polycystic kidney disease (ADPKD), and data from the TEMPO 3:4 trial suggested that tolvaptan, a vasopressin V2 receptor antagonist, may have a positive effect on kidney pain in this patient group.

Tolvaptan and Kidney Pain in Patients With Autosomal ...

Tolvaptan Oral : Uses, Side Effects, Interactions ...

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Find patient medical information for Tolvaptan Oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings.

Tolvaptan Oral : Uses, Side Effects, Interactions ...

Clinical Trial Efficacy | JYNARQUE™ HCP (tolvaptan) tablets

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This end point was assessed as slope of eGFR during treatment (from end of titration to last on-drug visit) JYNARQUE-treated patients had a 26.4% reduction in the rate of kidney function decline compared with placebo (-2.7 versus -3.7 [mL/min/1.73 m 2 /year], P<0.0001) 6; Of the subjects enrolled in the trial, 5% of subjects in the tolvaptan arm and 2% in the placebo arm either had missing ...

Clinical Trial Efficacy | JYNARQUE™ HCP (tolvaptan) tablets

Clinical studies | PKD Foundation

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Know what’s happening with Alerts and updates. One of the largest impediments to clinical trial patient participation begins with awareness. We believed it was our goal to address this challenge and launched the Clinical Trials Awareness Program (CTAP), an aggressive program to increase awareness of PKD clinical studies among patients and families.. The goal is to simplify the process of ...

Clinical studies | PKD Foundation

Determinants of Urine Volume in ADPKD Patients Using the ...

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The vasopressin V2 receptor antagonist (V2RA) tolvaptan is the first drug that has been shown to slow the rate of kidney function decline in patients with autosomal dominant polycystic kidney disease (ADPKD). However, V2RAs also cause polyuria, with urine output that averages 6L/d. We assessed determinants of urine volume in patients with ADPKD using V2RAs because such information may …

Determinants of Urine Volume in ADPKD Patients Using the ...

Homepage | SAMSCA® (tolvaptan)

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WARNING: NOT FOR USE FOR AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) Because of the risk of hepatotoxicity, tolvaptan should not be used for ADPKD outside of the FDA-approved REMS. SAMSCA is contraindicated in the following conditions: — Use in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) outside of FDA-approved ...

Homepage | SAMSCA® (tolvaptan)

REPRISE: tolvaptan in advanced polycystic kidney disease

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study drug discontinuation (97% of random-ized participants). Among participants who completed the trial, 11% in the tolvaptan group and 3% in the placebo group discontinued the study drug before month 12. Adjusting for time on treatment, the mean decrease …

REPRISE: tolvaptan in advanced polycystic kidney disease

Recommendations for the use of tolvaptan in autosomal ...

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Autosomal polycystic kidney disease (ADPKD) is the most common Mendelian kidney disease, with a high but variable risk of progression to end-stage kidney disease. Preclinical studies demonstrate an important role for vasopressin in promoting cyst growth and disease progression.1 The phase 3 Tolvaptan Efficacy and Safety in the Management of ADPKD and its Outcomes (TEMPO) trial included ADPKD ...

Recommendations for the use of tolvaptan in autosomal ...

REPRISE: tolvaptan in advanced polycystic kidney disease ...

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Tolvaptan looks promising as a treatment for ADPKD, though it remains in clinical trials in the USA. Tolvaptan reduces the rate of increasing kidney size. With any drug, the side effects need to be balanced against the benefits.

REPRISE: tolvaptan in advanced polycystic kidney disease ...

Tolvaptan - Pkdiet

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4/26/2018 · Tolvaptan has received FDA marketing clearance as a treatment for rapidly progressing autosomal dominant polycystic kidney disease (ADPKD) in adults. It …

Tolvaptan - Pkdiet
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