Trial Information

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

Summary

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

Phase: Phase 3

Sponsor: C.T. Development America, Inc.

Overall Contacts:

Monika Deme, MD
31630037735
monika.deme@ppdi.com

Locations (60)

Country	State	City	Zip	Facility and Contact
United States	California	Glendale	91204	Raffi Minasian MD a Medical Corporation Raffi Minasian, MD Principal Investigator
United States	California	Los Angeles	90048	Cedars-Sinai Medical Center Maria Buscemi 310-248-6594 maria.buscemi@cshs.org Robert Vescio, MD Principal Investigator
United States	Indiana	Indianapolis	46202	Indiana University Joyce Hardwick 317-988-4092 jhardwic@iupui.edu Merrill Benson, MD Principal Investigator
United States	Maryland	Bethesda	20892-1662	National Institute of Arthritis and Musculoskeletal and Skin Diseases Anne Jones 301-443-5422 ajones@mail.nih.gov Amanda K. Ombrello, MD Principal Investigator
United States	Massachusetts	Boston	02118	Boston Medical Center Elizabeth Hankinson 617-638-4494 Hankea4@bu.edu John L. Berk, MD Principal Investigator
United States	Minnesota	Rochester	55905	Mayo Clinic Tammy Evans 507-284-1004 evans.tamara@mayo.edu Stephen B. Erickson, MD Principal Investigator
United States	Ohio	Columbus	43210	Ohio State University Medical Center Mindy Bowers 614-293-3437 mindy.bowers@osumc.edu Yvonne A. Efebera, MD Principal Investigator
Belgium		Leuven	3000	UZ Leuven Cindy Beerten +3216345675 cindy.beerten@uzleuven.be Bert Bammens, MD Principal Investigator
Brazil		Curitiba, Parana	80050-350	Associação Paranaense De Cultura - APC / Hospital Universitário Cajuru da PUCPR Ludimila Guedim Campos +55 41 3271 3150 ludimilaguedim@yahoo.com.br Roberto F. Pecoits-Filho, MD Principal Investigator
Bulgaria		Sofia	1606	University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski" Tsvetelina Yoneva tz_yoneva@abv.bg Rasho K. Rashkov, MD Principal Investigator
Bulgaria		Sofia	1431	University Multiprofile Hospital for Active Treatment "Aleksandrovska" Regina Djerassi +35929230263 Boris Bogov, MD Principal Investigator
Chile		Santiago	7501126	Centro de Estudios Reumatológicos Cecilia Napoli +5629192928 cnapolig@gmail.com Pedro Miranda, MD Principal Investigator
Czech Republic		Praha 2	128 08	Vseobecna fakultni nemocnice v Praze Lucie Malechova +420224962585 lucie.malechova@vfn.cz Romana Rysava,, MD Principal Investigator
Egypt		Cairo	11214	Al Hussain University Hospital Yasser Abdel-Motteleb +20106313361 Hassan M. Bassiouni, MD Principal Investigator
Egypt		Cairo		Ain Shams University Hospital Sabry A. Gohar, MD Principal Investigator
Egypt		Cairo		Sayed Galal University Hospital Ahmed Ghitany +20100011576 Hesham S. Hamoud, MD Principal Investigator
Finland		Helsinki	FI-00290	Helsingin yliopistollinen keskussairaala / Meilahti Arja Kaarto +358 50 427 0124 arja.kaarto@hus.fi Marjatta Leirisalo-Repo, MD Principal Investigator
France		Creteil	94010	Hôpital Henri Mondor Stéphane Baraldi +33 3 20 44 50 48 Stephane.BARALDI@CHRU-LILLE.FR Philippe Remy, MD Principal Investigator
France		Lille	59037	Hôpital Claude Huriez Stéphane Baraldi +33 3 20 44 50 48 Stephane.BARALDI@CHRU-LILLE.FR Eric Hachulla, MD Principal Investigator
Germany		Heidelberg	69120	Universität Heidelberg Stefanie Landwehr +496221 56 37358 Stefanie.Landwehr@med.uni-heidelberg.de Jörg Beimler, MD Principal Investigator
India		Jaipur	302020	Dr. Mukesh Jain Clinic Sushma Rai (919) 636-9083 x52 Mukesh K. Jain, MD Principal Investigator
India		Manipal	576104	Kasturba Medical College Sadhana Shanbhag +91 08202574314 sadhana.ss@manipal.edu Sudha Vidyasagar, MD Principal Investigator
India		Nadiad	387001	Muljibhai Patel Urological Hospital Monil Parmar +9126-825-2032 x5 Sishir Gang, MD Principal Investigator
India		New Delhi	110060	Sir Ganga Ram Hospital Swati Chhabra +91-9873467778 swatic45@gmail.com Atul Kakkar, MD Principal Investigator
Israel		Haifa	31048	Bnei Zion Medical Center Svetlana Petrovich +972(4) 835-9685 svetlana.petrovich@b-zion.org.il Itzhak Rosner, MD Principal Investigator
Israel		Ramat-Gan	52621	The Chaim Sheba Medical Center Yifat Kedar +972 35302156 yifat.kedar@sheba.health.gov.il Avi Livneh, MD Principal Investigator
Italy		Modena	41100	Azienda Ospedaliero-Universitaria di Modena Policlinico Riccardo Magistroni +39 059 4224136 riccardo.magistroni@unimo.it Gianni Cappelli, MD Principal Investigator
Italy		Pavia	27100	IRCCS Policlinico San Matteo Leda Roggeri leda78@gmail.com Giampaolo Merlini, MD Principal Investigator
Lithuania		Kaunas	LT-50009	Hospital of Lithuanian University of Health Sciences Kaunas Clinics Margarita Pileckyte +370 37 326 220 Asta Baranauskaite, MD Principal Investigator
Lithuania		Vilnius	LT-08661	Vilnius University Hospital Santariskiu Klinikos Inesa Arstikyte +370 523 65 301 Irena Butrimiene, MD Principal Investigator
Mexico		Aguascalientes	20230	Centenario Hospital Miguel Hidalgo Elva Maria Torres Alba +52 449 994 6720 x4544 elva.torres@clinicasancosme.com.mx Alfredo Chew Wong, MD Principal Investigator
Mexico		Monterrey	64240	Unidad Medica de Tratamientos Avanzados S.C. Virginia Peña Lopez +52 818 301 2342 vickypenalopez@hotmail.com David Lopez Villezca, MD Principal Investigator
Netherlands		Groningen	9713 GZ	Universitair Medisch Centrum Groningen Janita Bulthuis-Kuiper +31503610708 j.bulthuis-kuiper@int.umcg.nl B. P. Hazenberg, MD Principal Investigator
Netherlands		Maastricht	6229 Hx	Academisch Ziekenhuis Maastricht Veronique Gelissen +31433877922 veronique.gelissen@mumc.nl P. Van Paassen, MD Principal Investigator
Peru		Lima	Lima 1	Hospital Nacional Arzobispo Loayza Ana Isabel Tapia Aguilar +51 1 990052618 Anibel2601@yahoo.es Elizabeth T. Escudero Lozano, MD Principal Investigator
Poland		Olsztyn	10-561	Wojewodzki Szpital Specjalistyczny Norbert Kwella +48(89) 538 63 73 lnkwella@poczt.onet.pl Tomasz P. Stompor, MD Principal Investigator
Poland		Warszawa	02-653	ARS RHEUMATICA Sp. z o.o. Ewa Kaminska-Tchorzewska ewakamt@wp.pl Anna Zubrzycka-Sienkiewicz, MD Principal Investigator
Poland		Wroclaw	50-556	Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Arkadiusz Chlebicki arek778@tlen.pl Piotr Wiland,, MD Principal Investigator
Russian Federation		Ekaterinburg	620102	Sverdlovsk Regional Clinical Hospital #1 Anna Nikolaevna Sibiryakova +7 343 351 16 47 sibiryakova_anna@mail.ru Olga M. Lesnyak, MD Principal Investigator
Russian Federation		Kemerovo	650066	Kemerovo State Medical Academy of Roszdrav Svetlana Anatolyevna Smakotina +7(3) 842 39 64 x58 smak67@mail.ru Olga L. Barbarash, MD Principal Investigator
Russian Federation		Moscow	115522	Institute of Rheumatology of RAMN Marina Leonidovna Stanislav +7(4) 996 14 44 x88 marista@bk.ru Evgeny Nasonov, MD Principal Investigator
Russian Federation		Novosibirsk	630117	Research Institute of Clinical and Experimental Lymphology Svetlana Alexandrovna Lapsina +7 3833 32 03 27 lapsinas@bk.ru Elena V. Zonova, MD Principal Investigator
Russian Federation		St. Petersburg	191015	North-West State Medical University n.a. I.I. Mechnikov Liya Nikolaevna Belousova +7(8) 125 43 04 x60 liya-belousova@yandex.ru Yury P. Uspenskiy, MD Principal Investigator
Spain		Barcelona	08036	Hospital Clinic de Barcelona Sara Herrero +34 93 227 5545 sherrer1@clinic.ub.es Josep Maria Campistol, MD Principal Investigator
Spain		Malaga	29009	Hospital Civil Carlos Haya Remedios Toledo Rojas +34 951291174 remedios.toledorojas@gmail.com Antonio Fernández-Nebró, MD Principal Investigator
Sweden		Stockholm	SE-14186	Karolinska Universitetssjukhuset i Huddinge Ann-Christina Emmoth +46 585 825 50 Peter Bárány, MD Principal Investigator
Tunisia		Monastir	5000	Fattouma Bourguiba University Hospital Sabra El Aloui +21673461144 Habib Skhiri, MD Principal Investigator
Tunisia		Sfax	3029	Hedi Chaker University Hospital Mahmoud Kharrat +21674247779 Jamil Hachicha, MD Principal Investigator
Tunisia		Sousse	4020	Sahloul Hospital Dorsaf Zallema dorsafzel@yahoo.fr Abdellatif Achour, MD Principal Investigator
Tunisia		Tunis	1006	Hôpital Charles Nicolle Rim Goucha +21620337385 senda.goucha@rns.tn Adel Kheder, MD Principal Investigator
Tunisia		Tunis	1007	La Rabta Hospital Lilia Ben Fatma lamia.triki@rns.tn Fatma Ben Moussa, MD Principal Investigator
Turkey		Adana	01330	Cukurova University Medical Faculty Balcali Hospital Asli Hikmet Kurtoglu +905309616662 asli-hikmet.kurtoglu@staffoutsourcing.com;asli_bio@hotmail.com Eren Erken, MD Principal Investigator
Turkey		Ankara	06100	Hacettepe University Medical Faculty Gulen Tugba +905309620489 tugba.gulen@staff-outsourcing.com Mustafa Arici, MD Principal Investigator
Turkey		Eskisehir	26480	Eskisehir Osmangazi University Medical Faculty Halise Metin +905334509689 halisemetin@hotmail.com Cengiz Korkmaz, MD Principal Investigator
Ukraine		Donetsk	83114	Municipal Treatment-Prophylactic Institution Central City Clinical Hospital #1 Denys Puzikov +380622574074 Oleksandr I. Dyadyk, MD Principal Investigator
Ukraine		Donetsk	83003	Municipal Medical & Preventive Institution Donetsk Regional Clinical Territorial Medical Association Tetyana Bevzenko +380503269136 tanya.bevzenko@gmail.com Oleg V. Syniachenko, MD Principal Investigator
Ukraine		Kyiv	04050	State Institution "Institute of Nephrology of AMS of Ukraine" Maryna Velychko +380444559377 nauca@inephrology.kiev.ua Mykola O. Kolesnyk, MD Principal Investigator
Ukraine		Kyiv	03680	National Scientific Center "Institute of cardiology n.a. academician M.D Strazhesko" Olena Garmish +38067 960 02 53 Volodymyr Kovalenko, MD Principal Investigator
Ukraine		Kyiv	2125	State Institution "Institute of Nephrology of AMS of Ukraine" Valentina Savchuk +380445126474 savalm@bigmir.net Iryna O. Dudar, MD Principal Investigator
United Kingdom		London	NW3 2PF	Royal Free Hospital Thirusha Lane +44 (0) 20 7433 2759 t.lane@ucl.ac.uk Helen Lachmann, MD Principal Investigator

NCT ID:NCT01215747

Date Last Changed: February 28, 2013