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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


Phase 3
18 Years
80 Years
Open (Enrolling)
Both
Amyloidosis

Thank you

Trial Information

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Time from baseline to a persistent decrease in Creatinine clearance (CrCL) of 40% or more, a persistent increase in Serum Creatinine(SCr) of 80% or more, or progression to end-stage renal disease(ESRD)

Outcome Time Frame:

Up to 24 months

Safety Issue:

No

Principal Investigator

Tomasz Sablinski, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

CT Development America, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

CL-503012

NCT ID:

NCT01215747

Start Date:

November 2010

Completion Date:

May 2014

Related Keywords:

  • Amyloidosis
  • Kiacta for AA amyloidosis
  • Amyloidosis

Name

Location

Mayo ClinicRochester, Minnesota  55905
Stanford UniversityStanford, California  94305
Cedars-Sinai Medical CenterLos Angeles, California  90048
Boston Medical CenterBoston, Massachusetts  02118
Ohio State University Medical CenterColumbus, Ohio  43210
Indiana UniversityIndianapolis, Indiana  46202
Barbara Ann Karmanos Cancer CenterDetroit, Michigan  48201
National Institute of Arthritis and Musculoskeletal and Skin DiseasesBethesda, Maryland  20892-1662
Raffi Minasian MD a Medical CorporationGlendale, California  91204