Safety, Tolerability and Efficacy of KAI-4169 in Hemodialysis Subjects With Secondary Hyperparathyroidism

Status:	Completed
Conditions:	Endocrine
Therapuetic Areas:	Endocrinology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	March 2011
End Date:	August 2011

A Double-Blind, Randomized, Placebo-Controlled Multiple Ascending Dose Study to Assess the Safety, Tolerability and Efficacy of KAI-4169 in Hemodialysis Subjects With Secondary Hyperparathyroidism

The purpose of this study is to characterize the safety and tolerability and efficacy of
multiple ascending doses of KAI-4169 in hemodialysis subjects for the treatment of secondary
hyperparathyroidism.

Inclusion Criteria:

- Subject provides written informed consent.

- Intact PTH at least 350 pg/mL.

- Corrected calcium at least 9.0 mg/dL.

- Hemoglobin at least 9.0 g/dL.

- Adequate hemodialysis three times per week.

- Excepting chronic renal failure, subject is judged to be in stable medical condition
based on medical history, physical examination, and routine laboratory tests.

Exclusion Criteria:

- History or symptomatic ventricular dysrhythmias.

- History of angina pectoris or congestive heart failure

- History of myocardial infarction, coronary angioplasty, or coronary artery bypass
grafting within the past 6 months.

- History of or treatment for seizure disorder.

- Recent (3 months) parathyroidectomy.

- Serum transaminases (alanine aminotransferase, aspartate aminotransferase) greater
than two times the upper limit of normal at screening.

We found this trial at

sites

Clinical Trial Facility in Macon Georgia

Macon, Georgia 31217

from

Macon, GA