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