KIACTA to prevent kidney function worsening in AA amyloidosis patients
Research type
Research Study
Full title
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
IRAS ID
63714
Contact name
Helen Lachmann
Sponsor organisation
Celtic Therapeutics Development Switzerland SARL
Eudract number
2010-022313-25
Clinicaltrials.gov Identifier
Research summary
Amyloidosis is the general term for a number of diseases in which the build up of abnormal proteins (amyloid) leads to dysfunction or failure of the involved organs. AA amyloidosis results from the build up of amyloid A protein. It is a complication of chronic inflammatory conditions such as arthritis, chronic infections and familial Mediterranean fever. Rheumatoid arthritis is the major cause of AA amyloidosis in Western Europe. AA amyloidosis mainly affects the kidney, spleen, liver and adrenal glands. The most common feature of the disease is kidney dysfunction. End-stage kidney failure is the cause of death in 40-60% of cases. The average survival time from diagnosis varies from 2-13 years. Current treatment is based on controlling the underlying disease to slow progression of AA amyloidosis. Kiacta has been designed to specifically inhibit the build up of amyloid A protein. Kiacta has previously been administered to 179 people and has been found to be safe and well tolerated. The purpose of this study is to assess the efficacy and safety of treatment with Kiacta. Efficacy will be assessed by looking at kidney function and safety will be assessed by looking at side effects. Participants will be randomly assigned to receive Kiacta or placebo in a 1:1 ratio. The daily dose they receive will depend on kidney function. Participants will continue to take study drug until they experience end-stage kidney disease, have worsening of kidney function after 24 months of treatment or until the study is ended. During this time, participants will attend the clinic every 3 months where procedures performed will include: vital signs, ECG, physical examination, urine and blood samples. This study is sponsored by C.T. Development Switzerland SARL. Approximately 230 patients will participate in this study in 30 countries worldwide, with 30 patients from the National Amyloidosis Centre in the UK.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
11/LO/0180
Date of REC Opinion
7 Apr 2011
REC opinion
Favourable Opinion