Efficacy and Safety Study of KIACTA in Preventing Renal Function Decline in AA Amyloidosis
NCT ID: NCT01215747
Last Updated: 2016-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
261 participants
INTERVENTIONAL
2010-11-30
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Kiacta (eprodisate disodium)
KIACTA (eprodisate disodium)
Orally 1 to 3 capsules (Kiacta 400 mg) twice daily and adjusted as per the Creatine Clearance (CrCl) level increases or decreases.
Placebo
Placebo
Orally 1 to 3 capsules (placebo) twice daily and adjusted as per the Creatine Clearance (CrCl) level increases or decreases:
Interventions
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KIACTA (eprodisate disodium)
Orally 1 to 3 capsules (Kiacta 400 mg) twice daily and adjusted as per the Creatine Clearance (CrCl) level increases or decreases.
Placebo
Orally 1 to 3 capsules (placebo) twice daily and adjusted as per the Creatine Clearance (CrCl) level increases or decreases:
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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C.T. Development America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Tomasz Sablinski, MD, PhD
Role: STUDY_DIRECTOR
CT Development America, Inc.
Locations
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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
Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, , Poland
Kemerovo State Medical Academy of Roszdrav
Kemerovo, , Russia
Institute of Rheumatology of RAMN
Moscow, , Russia
Research Institute of Clinical and Experimental Lymphology
Novosibirsk, , Russia
Sverdlovsk Regional Clinical Hospital #1
Yekaterinburg, , Russia
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Civil Carlos Haya
Málaga, , Spain
Karolinska Universitetssjukhuset i Huddinge
Stockholm, , Sweden
Fattouma Bourguiba University Hospital
Monastir, , Tunisia
Hedi Chaker University Hospital
Sfax, , Tunisia
Sahloul Hospital
Sousse, , Tunisia
Hôpital Charles Nicolle
Tunis, , Tunisia
La Rabta Hospital
Tunis, , Tunisia
Cukurova University Medical Faculty Balcali Hospital
Adana, , Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Eskisehir Osmangazi University Medical Faculty
Eskişehir, , Turkey (Türkiye)
Municipal Medical & Preventive Institution Donetsk Regional Clinical Territorial Medical Association
Donetsk, , Ukraine
National Scientific Center "Institute of cardiology n.a. academician M.D Strazhesko"
Kyiv, , Ukraine
State Institution "Institute of Nephrology of AMS of Ukraine"
Kyiv, , Ukraine
State Institution "Institute of Nephrology of AMS of Ukraine"
Kyiv, , Ukraine
Royal Free Hospital
London, , United Kingdom
Countries
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Other Identifiers
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CL-503012
Identifier Type: -
Identifier Source: org_study_id
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