Efficacy and Safety Study of KIACTA in Preventing Renal Function Decline in AA Amyloidosis
Completed · Phase 3 · Has a placebo group
Conditions studied: Amyloidosis
In brief
The primary purpose of this study is to assess the efficacy and safety of treatment with Kiacta in adult patients with AA Amyloidosis.
Key facts
- Study ID
- NCT01215747
- Run by
- C.T. Development America, Inc.
- People needed
- 261
- Starts
- 2010-11-01
- Expected to finish
- 2016-03-01
- Last updated by the study team
- 2016-03-10
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Raffi Minasian MD a Medical Corporation — Glendale, California, United States
- Boston Medical Center — Boston, Massachusetts, United States
- Ohio State University Medical Center — Columbus, Ohio, United States
- UZ Leuven — Leuven, Belgium
- Al Hussain University Hospital — Cairo, Egypt
- Tartu University Hospital — Tartu, Estonia
- Helsingin yliopistollinen keskussairaala / Meilahti — Helsinki, Finland
- Hôpital Henri Mondor — Créteil, France
- Hôpital Claude Huriez — Lille, France
- Tbilisi Heart and Vascular Clinic Ltd — Tbilisi, Georgia
- Universität Heidelberg — Heidelberg, Germany
- Regency Hospital — Kanpur, India
- Muljibhai Patel Urological Hospital — Nadiād, India
- Sir Ganga Ram Hospital — New Delhi, India
- Bnei Zion Medical Center — Haifa, Israel
- The Chaim Sheba Medical Center — Ramat Gan, Israel
- IRCCS Policlinico San Matteo — Pavia, Italy
- Pauls Stradins Clinical University Hospital — Riga, Latvia
- Hospital of Lithuanian University of Health Sciences Kaunas Clinics — Kaunas, Lithuania
- Vilnius University Hospital Santariskiu Klinikos — Vilnius, Lithuania
- Universitair Medisch Centrum Groningen — Groningen, Netherlands
- Academisch Ziekenhuis Maastricht — Maastricht, Netherlands
- Hospital Nacional Arzobispo Loayza — Lima, Peru
- Wojewodzki Szpital Specjalistyczny — Olsztyn, Poland
- ARS RHEUMATICA Sp. z o.o. — Warsaw, Poland
Full record on ClinicalTrials.gov
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