Status:
COMPLETED
Efficacy and Safety Study of KIACTA in Preventing Renal Function Decline in AA Amyloidosis
Lead Sponsor:
C.T. Development America, Inc.
Conditions:
Amyloidosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The primary purpose of this study is to assess the efficacy and safety of treatment with Kiacta in adult patients with AA Amyloidosis.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
261 Patients enrolled
Trial Details
Trial ID
NCT01215747
Start Date
November 1 2010
End Date
March 1 2016
Last Update
March 10 2016
Active Locations (46)
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1
Raffi Minasian MD a Medical Corporation
Glendale, California, United States, 91204
2
Boston Medical Center
Boston, Massachusetts, United States, 02118
3
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
4
UZ Leuven
Leuven, Belgium, 3000