Efficacy and Safety Study of KIACTA in Preventing Renal Function Decline in AA Amyloidosis

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to assess the efficacy and safety of treatment with Kiacta in adult patients with AA Amyloidosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: C.T. Development America, Inc.

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