Efficacy and Safety Study of KIACTA in Preventing Renal Function Decline in AA Amyloidosis
- Conditions
- Amyloidosis
- Interventions
- Drug: PlaceboDrug: KIACTA (eprodisate disodium)
- Registration Number
- NCT01215747
- Lead Sponsor
- C.T. Development America, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 261
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Kiacta (eprodisate disodium) KIACTA (eprodisate disodium) -
- Primary Outcome Measures
Name Time Method 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) Up to 24 months
- Secondary Outcome Measures
Name Time Method Progression to end-stage renal disease (ESRD) baseline, every 3 months to end of study visit urinary protein/creatinine ratio screening, baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit Time from baseline to persistent decrease in CrCL of 40% or more, a persistent increase in SCr of 80% or more, progression to ESRD, or all-cause mortality Up to 24 months serum amyloid A baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit serum cystatin C over time baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit rate of change (slope) in creatinine clearance (CrCL) over time baseline to primary endpoint, measured every 3 months to end of study visit estimated glomerular filtration rate (eGFR) screening, baseline, every 3 months, 12 months , early termination, treatment completion, end of study visit
Trial Locations
- Locations (45)
Hôpital Henri Mondor
🇫🇷Creteil, France
Hôpital Charles Nicolle
🇹🇳Tunis, Tunisia
Hôpital Claude Huriez
🇫🇷Lille, France
UZ Leuven
🇧🇪Leuven, Belgium
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Karolinska Universitetssjukhuset i Huddinge
🇸🇪Stockholm, Sweden
Royal Free Hospital
🇬🇧London, United Kingdom
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Raffi Minasian MD a Medical Corporation
🇺🇸Glendale, California, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Tartu University Hospital
🇪🇪Tartu, Estonia
Helsingin yliopistollinen keskussairaala / Meilahti
🇫🇮Helsinki, Finland
Universität Heidelberg
🇩🇪Heidelberg, Germany
Regency Hospital
🇮🇳Kanpur, India
The Chaim Sheba Medical Center
🇮🇱Ramat-Gan, Israel
Pauls Stradins Clinical University Hospital
🇱🇻Riga, Latvia
Sverdlovsk Regional Clinical Hospital #1
🇷🇺Ekaterinburg, Russian Federation
Fattouma Bourguiba University Hospital
🇹🇳Monastir, Tunisia
Hospital Civil Carlos Haya
🇪🇸Malaga, Spain
Municipal Medical & Preventive Institution Donetsk Regional Clinical Territorial Medical Association
🇺🇦Donetsk, Ukraine
IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
Research Institute of Clinical and Experimental Lymphology
🇷🇺Novosibirsk, Russian Federation
Hacettepe University Medical Faculty
🇹🇷Ankara, Turkey
Institute of Rheumatology of RAMN
🇷🇺Moscow, Russian Federation
Bnei Zion Medical Center
🇮🇱Haifa, Israel
Academisch Ziekenhuis Maastricht
🇳🇱Maastricht, Netherlands
Al Hussain University Hospital
🇪🇬Cairo, Egypt
Tbilisi Heart and Vascular Clinic Ltd
🇬🇪Tbilisi, Georgia
Universitair Medisch Centrum Groningen
🇳🇱Groningen, Netherlands
Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
🇵🇱Wroclaw, Poland
La Rabta Hospital
🇹🇳Tunis, Tunisia
Eskisehir Osmangazi University Medical Faculty
🇹🇷Eskisehir, Turkey
National Scientific Center "Institute of cardiology n.a. academician M.D Strazhesko"
🇺🇦Kyiv, Ukraine
Muljibhai Patel Urological Hospital
🇮🇳Nadiad, India
Kemerovo State Medical Academy of Roszdrav
🇷🇺Kemerovo, Russian Federation
State Institution "Institute of Nephrology of AMS of Ukraine"
🇺🇦Kyiv, Ukraine
Sir Ganga Ram Hospital
🇮🇳New Delhi, India
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
🇱🇹Kaunas, Lithuania
Vilnius University Hospital Santariskiu Klinikos
🇱🇹Vilnius, Lithuania
Hospital Nacional Arzobispo Loayza
🇵🇪Lima, Peru
ARS RHEUMATICA Sp. z o.o.
🇵🇱Warszawa, Poland
Hedi Chaker University Hospital
🇹🇳Sfax, Tunisia
Sahloul Hospital
🇹🇳Sousse, Tunisia
Wojewodzki Szpital Specjalistyczny
🇵🇱Olsztyn, Poland
Cukurova University Medical Faculty Balcali Hospital
🇹🇷Adana, Turkey