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Advancing understanding of treatment through clinical trials
Date:11/3/2012

This condition causes kidney cysts often associated with pain, hypertension, and kidney failure. The phase 3, multi-center, double-blind, placebo-controlled, 3-year trial included 1445 ADPKD patients who were randomized 2:1 to split dose tolvaptan (45/15, 60/30 or 90/30 mg daily as tolerated) or placebo.
  • Total kidney volume increase over 3 years was halved in patients treated with tolvaptan compared to placebo (2.80%/year versus 5.51%/year).
  • Patients taking tolvaptan were 61% less likely to experience a certain level of worsening kidney function and 36% less likely to experience kidney pain requiring treatment.
  • Tolvaptan slowed the rate of kidney function decline compared with placebo.

"Tolvaptan demonstrated clinically meaningful disease-specific benefits for ADPKD patients which may be clinically meaningful," said Dr. Torres. While the trial findings are encouraging, tolvaptan has not yet been approved for this indication.

A third trial, called EVOLVE, was designed to test the hypothesis that treatment with cinacalcet compared with placebo reduces the risk of premature death or non-fatal heart-related events among dialysis patients with secondary hyperparathyroidism. (Secondary hyperparathyroidism, when the parathyroid gland produces excess amounts of parathyroid hormone, arises in most patients with chronic kidney disease as their disease progresses. It can lead to a number of complications, including cardiovascular problems.) Results from analyses using multivariable adjustment and censoring data 6 months after patients stopped taking the drug will be presented, along with safety data, by Glenn Chertow, MD (Stanford University School of Medicine).


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Contact: Adrienne Lea
alea@asn-online.org
202-503-6560
American Society of Nephrology
Source:Eurekalert

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