Clinical Drug Experience Knowledgebase

Criteria

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