Clinical trial NCT01215747: Efficacy and Safety Study of KIACTA in Preventing Renal Function Decline in AA Amyloidosis
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Amyloidosis
Keywords: Kiacta for AA amyloidosis
Lead sponsor: C.T. Development America, Inc.
Sponsor class: INDUSTRY
First posted: 2010-10-06
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
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)
timeFrame: Up to 24 months
Secondary outcomes:
measure: rate of change (slope) in creatinine clearance (CrCL) over time
timeFrame: baseline to primary endpoint, measured every 3 months to end of study visit
measure: Progression to end-stage renal disease (ESRD)
timeFrame: baseline, every 3 months to end of study visit
measure: estimated glomerular filtration rate (eGFR)
timeFrame: screening, baseline, every 3 months, 12 months , early termination, treatment completion, end of study visit
measure: serum cystatin C over time
timeFrame: baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit
measure: urinary protein/creatinine ratio
timeFrame: screening, baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit
measure: serum amyloid A
timeFrame: baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit
measure: 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
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Raffi Minasian MD a Medical Corporation
state: California
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Leuven
country: Belgium
facility: UZ Leuven
city: Cairo
country: Egypt
facility: Al Hussain University Hospital
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Helsinki
country: Finland
facility: Helsingin yliopistollinen keskussairaala / Meilahti
city: Creteil
country: France
facility: Hôpital Henri Mondor
city: Lille
country: France
facility: Hôpital Claude Huriez
city: Tbilisi
country: Georgia
facility: Tbilisi Heart and Vascular Clinic Ltd
city: Heidelberg
country: Germany
facility: Universität Heidelberg
city: Kanpur
country: India
facility: Regency Hospital
city: Nadiad
country: India
facility: Muljibhai Patel Urological Hospital
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
city: Haifa
country: Israel
facility: Bnei Zion Medical Center
city: Ramat-Gan
country: Israel
facility: The Chaim Sheba Medical Center
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Klinikos
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
city: Lima
country: Peru
facility: Hospital Nacional Arzobispo Loayza
city: Olsztyn
country: Poland
facility: Wojewodzki Szpital Specjalistyczny
city: Warszawa
country: Poland
facility: ARS RHEUMATICA Sp. z o.o.
city: Wroclaw
country: Poland
facility: Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Clinical Hospital #1
city: Kemerovo
country: Russian Federation
facility: Kemerovo State Medical Academy of Roszdrav
city: Moscow
country: Russian Federation
facility: Institute of Rheumatology of RAMN
city: Novosibirsk
country: Russian Federation
facility: Research Institute of Clinical and Experimental Lymphology
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Malaga
country: Spain
facility: Hospital Civil Carlos Haya
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset i Huddinge
city: Monastir
country: Tunisia
facility: Fattouma Bourguiba University Hospital
city: Sfax
country: Tunisia
facility: Hedi Chaker University Hospital
city: Sousse
country: Tunisia
facility: Sahloul Hospital
city: Tunis
country: Tunisia
facility: Hôpital Charles Nicolle
city: Tunis
country: Tunisia
facility: La Rabta Hospital
city: Adana
country: Turkey
facility: Cukurova University Medical Faculty Balcali Hospital
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University Medical Faculty
city: Donetsk
country: Ukraine
facility: Municipal Medical & Preventive Institution Donetsk Regional Clinical Territorial Medical Association
city: Kyiv
country: Ukraine
facility: National Scientific Center "Institute of cardiology n.a. academician M.D Strazhesko"
city: Kyiv
country: Ukraine
facility: State Institution "Institute of Nephrology of AMS of Ukraine"
city: Kyiv
country: Ukraine
facility: State Institution "Institute of Nephrology of AMS of Ukraine"
city: London
country: United Kingdom
facility: Royal Free Hospital
Study officials:
affiliation: CT Development America, Inc.
name: Tomasz Sablinski, MD, PhD
role: STUDY_DIRECTOR
References: