Otsuka Phase III trial of Tolvaptan meets primary endpoint

5th November 2012 (Last Updated November 5th, 2012 18:30)

Otsuka Pharmaceutical has announced that its Phase III trial of Tolvaptan, an investigational compound for autosomal dominant polycystic kidney disease (ADPKD), has met its primary endpoint.

Otsuka Pharmaceutical has announced that its Phase III trial of Tolvaptan, an investigational compound for autosomal dominant polycystic kidney disease (ADPKD), has met its primary endpoint.

The placebo-controlled, parallel-arm study demonstrated nearly 50% reduction in the change of total kidney volume (TKV) among ADPKD patients, as compared to placebo, over a period of three years.

Mayo Clinic Division of Nephrology and Hypertension professor of medicine Dr Vicente Torres said ADPKD is the fourth most common overall cause and the most common inherited cause of kidney failure worldwide.

"The placebo-controlled, parallel-arm study demonstrated nearly 50% reduction in the change of total kidney volume (TKV) among ADPKD patients, as compared to placebo, over a period of three years."

"In most patients with this disease, relentless cyst growth within the kidneys destroys the tissue, causes hypertension and painful complications, and negatively impacts the quality of life," Torres said.

"The results of this study reveal a potential treatment that blunts kidney growth, lessens associated symptoms and slows kidney function decline when given over three years."

A statistically significant reduction in the risk of multiple events of worsening kidney function, kidney pain, hypertension or albuminuria were observed, meeting the key secondary endpoint of the randomised, double-blind study.

The common adverse events associated with tolvaptan therapy were linked to its aquaretic mode of action, while common adverse events reported in the placebo included renal pain, haematuria and urinary tract infection.

Otsuka Pharmaceutical Development & Commercialization president and CEO William Carson said; "Tolvaptan was discovered by Otsuka in Japan, and if approved by regulatory agencies, could become the first pharmaceutical therapy for patients who suffer from ADPKD."