Efficacy and Safety Study of KIACTA in Preventing Renal Function Decline in AA Amyloidosis

This study is currently recruiting participants.
Verified December 2013 by C.T. Development America, Inc.
Sponsor:
Information provided by (Responsible Party):
C.T. Development America, Inc.
ClinicalTrials.gov Identifier:
NCT01215747
First received: October 1, 2010
Last updated: March 21, 2014
Last verified: December 2013
  Purpose

The primary purpose of this study is to assess the efficacy and safety of treatment with Kiacta in adult patients with AA Amyloidosis.


Condition Intervention Phase
Amyloidosis
Drug: KIACTA (eprodisate disodium)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by C.T. Development America, Inc.:

Primary Outcome Measures:
  • 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) [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • rate of change (slope) in creatinine clearance (CrCL) over time [ Time Frame: baseline to primary endpoint, measured every 3 months to end of study visit ] [ Designated as safety issue: No ]
  • Progression to end-stage renal disease (ESRD) [ Time Frame: baseline, every 3 months to end of study visit ] [ Designated as safety issue: No ]
  • estimated glomerular filtration rate (eGFR) [ Time Frame: screening, baseline, every 3 months, 12 months , early termination, treatment completion, end of study visit ] [ Designated as safety issue: No ]
  • serum cystatin C over time [ Time Frame: baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit ] [ Designated as safety issue: No ]
  • urinary protein/creatinine ratio [ Time Frame: screening, baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit ] [ Designated as safety issue: No ]
  • serum amyloid A [ Time Frame: baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 230
Study Start Date: November 2010
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Kiacta (eprodisate disodium) Drug: 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 Comparator: Placebo Drug: Placebo
Orally 1 to 3 capsules (placebo) twice daily and adjusted as per the Creatine Clearance (CrCl) level increases or decreases:

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01215747

Contacts
Contact: Monika Deme, MD 31630037735 monika.deme@ppdi.com

  Hide Study Locations
Locations
United States, California
Raffi Minasian MD a Medical Corporation Recruiting
Glendale, California, United States, 91204
Principal Investigator: Raffi Minasian, MD         
Cedars-Sinai Medical Center Withdrawn
Los Angeles, California, United States, 90048
Stanford University Withdrawn
Stanford, California, United States, 94305
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Joyce Hardwick    317-988-4092    jhardwic@iupui.edu   
Principal Investigator: Merrill Benson, MD         
United States, Maryland
National Institute of Arthritis and Musculoskeletal and Skin Diseases Recruiting
Bethesda, Maryland, United States, 20892-1662
Contact: Anne Jones    301-443-5422    ajones@mail.nih.gov   
Principal Investigator: Amanda K. Ombrello, MD         
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Samantha Pappin, Study Coordinator    (617) 638-4494    Samantha.Pappin@bmc.org   
Principal Investigator: John L. Berk, MD         
United States, Michigan
Barbara Ann Karmanos Cancer Center Withdrawn
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic Terminated
Rochester, Minnesota, United States, 55905
United States, Ohio
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Mindy Bowers    614-293-3437    mindy.bowers@osumc.edu   
Principal Investigator: Yvonne A. Efebera, MD         
Argentina
CEMIC Withdrawn
Buenos Aires, Argentina, C1431FWO
Sanatorio Parque Withdrawn
Sante Fe, Argentina, S2000KZD
Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Cindy Beerten    +3216345675    cindy.beerten@uzleuven.be   
Principal Investigator: Bert Bammens, MD         
Brazil
Associação Paranaense De Cultura - APC / Hospital Universitário Cajuru da PUCPR Recruiting
Curitiba, Parana, Brazil, 80050-350
Contact: Ludimila Guedim Campos    +55 41 3271 3150    ludimilaguedim@yahoo.com.br   
Principal Investigator: Roberto F. Pecoits-Filho, MD         
Hospital Santa Marcelina Withdrawn
Sao Paulo, Brazil, 08270-070
Bulgaria
University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski" Withdrawn
Sofia, Bulgaria, 1606
University Multiprofile Hospital for Active Treatment "Aleksandrovska" Recruiting
Sofia, Bulgaria, 1431
Contact: Regina Djerassi    +35929230263      
Principal Investigator: Boris Bogov, MD         
Chile
Centro de Estudios Reumatológicos Withdrawn
Santiago, Chile, 7501126
Czech Republic
Vseobecna fakultni nemocnice v Praze Recruiting
Praha 2, Czech Republic, 128 08
Contact: Lucie Malechova    +420224962585    lucie.malechova@vfn.cz   
Principal Investigator: Romana Rysava,, MD         
Egypt
Al Hussain University Hospital Recruiting
Cairo, Egypt, 11214
Contact: Yasser Abdel-Motteleb    +20106313361      
Principal Investigator: Hassan M. Bassiouni, MD         
Ain Shams University Hospital Withdrawn
Cairo, Egypt
Sayed Galal University Hospital Recruiting
Cairo, Egypt
Contact: Ahmed Ghitany    +20100011576      
Principal Investigator: Hesham S. Hamoud, MD         
Estonia
West Tallinn Central Hospital - Internal Medicine, Nephrology Centre Recruiting
Tallinn, Estonia, EE-10617
Principal Investigator: Madis Ilmoja, MD         
Tartu University Hospital Not yet recruiting
Tartu, Estonia, EE-51014
Principal Investigator: Mai Rosenberg, MD         
Finland
Helsingin yliopistollinen keskussairaala / Meilahti Recruiting
Helsinki, Finland, FI-00290
Contact: Arja Kaarto    +358 50 427 0124    arja.kaarto@hus.fi   
Principal Investigator: Marjatta Leirisalo-Repo, MD         
France
Hôpital Henri Mondor Recruiting
Creteil, France, 94010
Contact: Stéphane Baraldi    +33 3 20 44 50 48    Stephane.BARALDI@CHRU-LILLE.FR   
Principal Investigator: Philippe Remy, MD         
Centre Hospitalier Le Mans Withdrawn
Le Mans, France
Hôpital Claude Huriez Recruiting
Lille, France, 59037
Contact: Stéphane Baraldi    +33 3 20 44 50 48    Stephane.BARALDI@CHRU-LILLE.FR   
Principal Investigator: Eric Hachulla, MD         
Hôpital Tenon Withdrawn
Paris, France, 75970
Hôpital de Rangueil Withdrawn
Toulouse Cedex9, France, 31059
Georgia
Tbilisi Heart and Vascular Clinic Ltd Recruiting
Tbilisi, Georgia, 0159
Principal Investigator: Lali Kilasonia, MD         
Germany
Schloßparkklinik Withdrawn
Berlin, Germany
KRH Klinikum Oststadt-Heidehaus Withdrawn
Hannover, Germany, 30659
Universität Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Stefanie Landwehr    +496221 56 37358    Stefanie.Landwehr@med.uni-heidelberg.de   
Principal Investigator: Jörg Beimler, MD         
India
Dr. Mukesh Jain Clinic Withdrawn
Jaipur, India, 302020
Regency Hospital Withdrawn
Kanpur, India, 208005
Kasturba Medical College Withdrawn
Manipal, India, 576104
Muljibhai Patel Urological Hospital Recruiting
Nadiad, India, 387001
Contact: Monil Parmar    +9126-825-2032 x5      
Principal Investigator: Sishir Gang, MD         
Sir Ganga Ram Hospital Recruiting
New Delhi, India, 110060
Contact: Swati Chhabra    +91-9873467778    swatic45@gmail.com   
Principal Investigator: Atul Kakkar, MD         
Israel
Bnei Zion Medical Center Recruiting
Haifa, Israel, 31048
Contact: Svetlana Petrovich    +972(4) 835-9685    svetlana.petrovich@b-zion.org.il   
Principal Investigator: Itzhak Rosner, MD         
The Chaim Sheba Medical Center Recruiting
Ramat-Gan, Israel, 52621
Contact: Yifat Kedar    +972 35302156    yifat.kedar@sheba.health.gov.il   
Principal Investigator: Avi Livneh, MD         
Italy
Azienda Ospedaliero-Universitaria di Modena Policlinico Recruiting
Modena, Italy, 41100
Contact: Riccardo Magistroni    +39 059 4224136    riccardo.magistroni@unimo.it   
Principal Investigator: Gianni Cappelli, MD         
IRCCS Policlinico San Matteo Recruiting
Pavia, Italy, 27100
Contact: Leda Roggeri       leda78@gmail.com   
Principal Investigator: Giampaolo Merlini, MD         
Arcispedale Santa Maria Nuova Withdrawn
Reggio Emilia, Italy, 42100
Latvia
Pauls Stradins Clinical University Hospital Not yet recruiting
Riga, Latvia, LV-1002
Principal Investigator: Aivars Petersons, MD         
Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas Clinics Recruiting
Kaunas, Lithuania, LT-50009
Contact: Margarita Pileckyte    +370 37 326 220      
Principal Investigator: Asta Baranauskaite, MD         
Vilnius University Hospital Santariskiu Klinikos Recruiting
Vilnius, Lithuania, LT-08661
Contact: Inesa Arstikyte    +370 523 65 301      
Principal Investigator: Irena Butrimiene, MD         
Mexico
Centenario Hospital Miguel Hidalgo Recruiting
Aguascalientes, Mexico, 20230
Contact: Elva Maria Torres Alba    +52 449 994 6720 x4544    elva.torres@clinicasancosme.com.mx   
Principal Investigator: Alfredo Chew Wong, MD         
Unidad Medica de Tratamientos Avanzados S.C. Withdrawn
Monterrey, Mexico, 64240
Netherlands
Universitair Medisch Centrum Groningen Recruiting
Groningen, Netherlands, 9713 GZ
Contact: Janita Bulthuis-Kuiper    +31503610708    j.bulthuis-kuiper@int.umcg.nl   
Principal Investigator: B. P. Hazenberg, MD         
Academisch Ziekenhuis Maastricht Recruiting
Maastricht, Netherlands, 6229 Hx
Contact: Veronique Gelissen    +31433877922    veronique.gelissen@mumc.nl   
Principal Investigator: P. Van Paassen, MD         
Peru
Clinica Medica San Martin E.I.R.L Withdrawn
Ica, Peru
Hospital Nacional Arzobispo Loayza Recruiting
Lima, Peru, Lima 1
Contact: Ana Isabel Tapia Aguilar    +51 1 990052618    Anibel2601@yahoo.es   
Principal Investigator: Elizabeth T. Escudero Lozano, MD         
Poland
Wojewodzki Szpital Specjalistyczny Recruiting
Olsztyn, Poland, 10-561
Contact: Norbert Kwella    +48(89) 538 63 73    lnkwella@poczt.onet.pl   
Principal Investigator: Tomasz P. Stompor, MD         
ARS RHEUMATICA Sp. z o.o. Recruiting
Warszawa, Poland, 02-653
Contact: Ewa Kaminska-Tchorzewska       ewakamt@wp.pl   
Principal Investigator: Anna Zubrzycka-Sienkiewicz, MD         
Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Recruiting
Wroclaw, Poland, 50-556
Contact: Arkadiusz Chlebicki       arek778@tlen.pl   
Principal Investigator: Piotr Wiland,, MD         
Russian Federation
Sverdlovsk Regional Clinical Hospital #1 Recruiting
Ekaterinburg, Russian Federation, 620102
Contact: Anna Nikolaevna Sibiryakova    +7 343 351 16 47    sibiryakova_anna@mail.ru   
Principal Investigator: Olga M. Lesnyak, MD         
Kemerovo State Medical Academy of Roszdrav Recruiting
Kemerovo, Russian Federation, 650066
Contact: Svetlana Anatolyevna Smakotina    +7(3) 842 39 64 x58    smak67@mail.ru   
Principal Investigator: Olga L. Barbarash, MD         
Institute of Rheumatology of RAMN Recruiting
Moscow, Russian Federation, 115522
Contact: Marina Leonidovna Stanislav    +7(4) 996 14 44 x88    marista@bk.ru   
Principal Investigator: Evgeny Nasonov, MD         
Research Institute of Clinical and Experimental Lymphology Recruiting
Novosibirsk, Russian Federation, 630117
Contact: Svetlana Alexandrovna Lapsina    +7 3833 32 03 27    lapsinas@bk.ru   
Principal Investigator: Elena V. Zonova, MD         
North-West State Medical University n.a. I.I. Mechnikov Recruiting
St. Petersburg, Russian Federation, 191015
Contact: Liya Nikolaevna Belousova    +7(8) 125 43 04 x60    liya-belousova@yandex.ru   
Principal Investigator: Yury P. Uspenskiy, MD         
Voronezh State Medical Academy n.a. N.N.Burdenko Withdrawn
Voronezh, Russian Federation, 394066
Spain
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Sara Herrero    +34 93 227 5545    sherrer1@clinic.ub.es   
Principal Investigator: Josep Maria Campistol, MD         
Hospital Civil Carlos Haya Recruiting
Malaga, Spain, 29009
Contact: Remedios Toledo Rojas    +34 951291174    remedios.toledorojas@gmail.com   
Principal Investigator: Antonio Fernández-Nebró, MD         
Sweden
Karolinska Universitetssjukhuset i Huddinge Recruiting
Stockholm, Sweden, SE-14186
Contact: Ann-Christina Emmoth    +46 585 825 50      
Principal Investigator: Peter Bárány, MD         
Tunisia
Fattouma Bourguiba University Hospital Recruiting
Monastir, Tunisia, 5000
Contact: Sabra El Aloui    +21673461144      
Principal Investigator: Habib Skhiri, MD         
Hedi Chaker University Hospital Recruiting
Sfax, Tunisia, 3029
Contact: Mahmoud Kharrat    +21674247779      
Principal Investigator: Jamil Hachicha, MD         
Sahloul Hospital Recruiting
Sousse, Tunisia, 4020
Contact: Dorsaf Zallema       dorsafzel@yahoo.fr   
Principal Investigator: Abdellatif Achour, MD         
Hôpital Charles Nicolle Recruiting
Tunis, Tunisia, 1006
Contact: Rim Goucha    +21620337385    senda.goucha@rns.tn   
Principal Investigator: Adel Kheder, MD         
La Rabta Hospital Recruiting
Tunis, Tunisia, 1007
Contact: Lilia Ben Fatma       lamia.triki@rns.tn   
Principal Investigator: Fatma Ben Moussa, MD         
Turkey
Cukurova University Medical Faculty Balcali Hospital Recruiting
Adana, Turkey, 01330
Contact: Asli Hikmet Kurtoglu    +905309616662    asli-hikmet.kurtoglu@staffoutsourcing.com;asli_bio@hotmail.com   
Principal Investigator: Eren Erken, MD         
Hacettepe University Medical Faculty Recruiting
Ankara, Turkey, 06100
Contact: Gulen Tugba    +905309620489    tugba.gulen@staff-outsourcing.com   
Principal Investigator: Mustafa Arici, MD         
Eskisehir Osmangazi University Medical Faculty Recruiting
Eskisehir, Turkey, 26480
Contact: Halise Metin    +905334509689    halisemetin@hotmail.com   
Principal Investigator: Cengiz Korkmaz, MD         
Ukraine
Municipal Medical & Preventive Institution Donetsk Regional Clinical Territorial Medical Association Recruiting
Donetsk, Ukraine, 83003
Contact: Tetyana Bevzenko    +380503269136    tanya.bevzenko@gmail.com   
Principal Investigator: Oleg V. Syniachenko, MD         
Municipal Treatment-Prophylactic Institution Central City Clinical Hospital #1 Withdrawn
Donetsk, Ukraine, 83114
State Institution "Institute of Nephrology of AMS of Ukraine" Recruiting
Kyiv, Ukraine, 2125
Contact: Valentina Savchuk    +380445126474    savalm@bigmir.net   
Principal Investigator: Iryna O. Dudar, MD         
State Institution "Institute of Nephrology of AMS of Ukraine" Recruiting
Kyiv, Ukraine, 04050
Contact: Maryna Velychko    +380444559377    nauca@inephrology.kiev.ua   
Principal Investigator: Mykola O. Kolesnyk, MD         
National Scientific Center "Institute of cardiology n.a. academician M.D Strazhesko" Recruiting
Kyiv, Ukraine, 03680
Contact: Olena Garmish    +38067 960 02 53      
Principal Investigator: Volodymyr Kovalenko, MD         
United Kingdom
Royal Free Hospital Recruiting
London, United Kingdom, NW3 2PF
Contact: Thirusha Lane    +44 (0) 20 7433 2759    t.lane@ucl.ac.uk   
Principal Investigator: Helen Lachmann, MD         
Sponsors and Collaborators
C.T. Development America, Inc.
Investigators
Study Director: Tomasz Sablinski, MD, PhD CT Development America, Inc.
  More Information

No publications provided

Responsible Party: C.T. Development America, Inc.
ClinicalTrials.gov Identifier: NCT01215747     History of Changes
Other Study ID Numbers: CL-503012
Study First Received: October 1, 2010
Last Updated: March 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by C.T. Development America, Inc.:
Kiacta for AA amyloidosis

Additional relevant MeSH terms:
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014