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

C.T. Development America

Status and phase

Completed

Phase 3

Conditions

Amyloidosis

Treatments

Drug: KIACTA (eprodisate disodium)

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01215747

CL-503012

Details and patient eligibility

About

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

Enrollment

261 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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