International Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Efficacy and Safety of KIACTA in Preventing Renal Function Decline in Patients With AA Amyloidosis

Inclusion Criteria:

- females must be of nonchildbearing potential (more than 1 yr postmenopausal)or use
effective contraception for at least 2 months prior to the baseline visit and through
30 days after the last dose of study medication

- confirmed diagnosis of AA amyloidosis demonstrated by positive biopsy using congo red
staining and immunohistochemistry or immunoelectronmicroscopy. Mass spectroscopy will
be used upon approval of the sponsor on a case to case basis.

- persistent proteinuria greater than 1 g/24h at 2 distinct 24-hr urine collections

- must have CrCl greater than 25 ml/min/1.73 m2 at 2 distinct 24 hr urine collections

Exclusion Criteria:

- evidence or suspicion of chronic kidney disease secondary to a disease other than AA
amyloidosis (eg, diabetes, long-standing uncontrolled hypertension, polycystic kidney
disease, recurring polynephritis, or systemic lupus erythematosus)

- history of kidney transplantation

- evidence or suspicion of a cause of potentially reversible acute renal failure within
3 months prior to baseline visit

- presence of concomitant diseases or medication that could interfere with the
interpretation of study results or compromise patient safety

- presence of condition that could reduce life expectancy to less than 2 yrs

- Type 1 or 2 diabetes mellitus

- significant hepatic enzyme elevation

- unstable angina, myocardial infarction, coronary artery bypass graft surgery, or
percutaneous transluminal coronary angioplasty within 6 months prior to the baseline
visit; presence of NY Heart Assoc class III or IV heart failure

- presence of, or history of stroke or transient ischemic attack within 6 months prior
to baseline visit

- initiation of, or any changes in, angiotensin converting enzyme inhibitor,
angiotensin II receptor antagonist therapy, or renin inhibitor within 3 months prior
to baseline visit

- initiation of, or any changes in, cytotoxic agents, anti-tumor necrosis factor
agents, anti interleukin-1 or 6 agents, or colchicine therapy within 3 months prior
to baseline visit

- previous use of Kiacta

- history of malignancy within 5 yrs prior to study entry, except for cervical
carcinoma in situ, nonmelanomatous carcinoma of the skin, or ductal carcinoma in situ
of the breast that has been surgically cured

- use of investigational drug within 30 days prior to the first screening visit

- active alcohol and/or drug abuse