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Research Study Summary

A Phase 3 clinical study for patients with Amyloidosis

Research Study 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


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

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Both Male and Female


18 to 80 Years

Overall Status


Lead Sponsor

C.T. Development America, Inc.


70 Months

Facility Type



Both Male and Female ages 18 Years to 80 Years

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

Site Locations (46)

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 Massachusetts Boston 02118 Boston Medical Center
Samantha Pappin, Study Coordinator
(617) 638-4494

John L. Berk, MD
Principal Investigator
United States Ohio Columbus 43210 Ohio State University Medical Center
Mindy Bowers

Yvonne A. Efebera, MD
Principal Investigator
Belgium Leuven 3000 UZ Leuven
Cindy Beerten

Bert Bammens, MD
Principal Investigator
Egypt Cairo 11214 Al Hussain University Hospital
Yasser Abdel-Motteleb

Hassan M. Bassiouni, MD
Principal Investigator
Egypt Cairo Sayed Galal University Hospital
Ahmed Ghitany

Hesham S. Hamoud, MD
Principal Investigator
Finland Helsinki FI-00290 Helsingin yliopistollinen keskussairaala / Meilahti
Arja Kaarto
+358 50 427 0124

Marjatta Leirisalo-Repo, MD
Principal Investigator
France Creteil 94010 Hôpital Henri Mondor
Stéphane Baraldi
+33 3 20 44 50 48

Philippe Remy, MD
Principal Investigator
France Lille 59037 Hôpital Claude Huriez
Stéphane Baraldi
+33 3 20 44 50 48

Eric Hachulla, MD
Principal Investigator
Georgia Tbilisi 0159 Tbilisi Heart and Vascular Clinic Ltd

Lali Kilasonia, MD
Principal Investigator
Germany Heidelberg 69120 Universität Heidelberg
Stefanie Landwehr
+496221 56 37358

Jörg Beimler, 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

Atul Kakkar, MD
Principal Investigator
Israel Haifa 31048 Bnei Zion Medical Center
Svetlana Petrovich
+972(4) 835-9685

Itzhak Rosner, MD
Principal Investigator
Israel Ramat-Gan 52621 The Chaim Sheba Medical Center
Yifat Kedar
+972 35302156

Avi Livneh, MD
Principal Investigator
Italy Modena 41100 Azienda Ospedaliero-Universitaria di Modena Policlinico
Riccardo Magistroni
+39 059 4224136

Gianni Cappelli, MD
Principal Investigator
Italy Pavia 27100 IRCCS Policlinico San Matteo
Leda Roggeri

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

Alfredo Chew Wong, MD
Principal Investigator
Netherlands Groningen 9713 GZ Universitair Medisch Centrum Groningen
Janita Bulthuis-Kuiper

B. P. Hazenberg, MD
Principal Investigator
Netherlands Maastricht 6229 Hx Academisch Ziekenhuis Maastricht
Veronique Gelissen

P. Van Paassen, MD
Principal Investigator
Peru Lima Lima 1 Hospital Nacional Arzobispo Loayza
Ana Isabel Tapia Aguilar
+51 1 990052618

Elizabeth T. Escudero Lozano, MD
Principal Investigator
Poland Olsztyn 10-561 Wojewodzki Szpital Specjalistyczny
Norbert Kwella
+48(89) 538 63 73

Tomasz P. Stompor, MD
Principal Investigator
Poland Warszawa 02-653 ARS RHEUMATICA Sp. z o.o.
Ewa Kaminska-Tchorzewska

Anna Zubrzycka-Sienkiewicz, MD
Principal Investigator
Poland Wroclaw 50-556 Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Arkadiusz Chlebicki

Piotr Wiland,, MD
Principal Investigator
Russian Federation Ekaterinburg 620102 Sverdlovsk Regional Clinical Hospital #1
Anna Nikolaevna Sibiryakova
+7 343 351 16 47

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

Olga L. Barbarash, MD
Principal Investigator
Russian Federation Moscow 115522 Institute of Rheumatology of RAMN
Marina Leonidovna Stanislav
+7(4) 996 14 44 x88

Evgeny Nasonov, MD
Principal Investigator
Russian Federation Novosibirsk 630117 Research Institute of Clinical and Experimental Lymphology
Svetlana Alexandrovna Lapsina
+7 3833 32 03 27

Elena V. Zonova, MD
Principal Investigator
Spain Barcelona 08036 Hospital Clinic de Barcelona
Sara Herrero
+34 93 227 5545

Josep Maria Campistol, MD
Principal Investigator
Spain Malaga 29009 Hospital Civil Carlos Haya
Remedios Toledo Rojas
+34 951291174

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

Habib Skhiri, MD
Principal Investigator
Tunisia Sfax 3029 Hedi Chaker University Hospital
Mahmoud Kharrat

Jamil Hachicha, MD
Principal Investigator
Tunisia Sousse 4020 Sahloul Hospital
Dorsaf Zallema

Abdellatif Achour, MD
Principal Investigator
Tunisia Tunis 1006 Hôpital Charles Nicolle
Rim Goucha

Adel Kheder, MD
Principal Investigator
Tunisia Tunis 1007 La Rabta Hospital
Lilia Ben Fatma

Fatma Ben Moussa, MD
Principal Investigator
Turkey Adana 01330 Cukurova University Medical Faculty Balcali Hospital
Asli Hikmet Kurtoglu

Eren Erken, MD
Principal Investigator
Turkey Ankara 06100 Hacettepe University Medical Faculty
Gulen Tugba

Mustafa Arici, MD
Principal Investigator
Turkey Eskisehir 26480 Eskisehir Osmangazi University Medical Faculty
Halise Metin

Cengiz Korkmaz, MD
Principal Investigator
Ukraine Donetsk 83003 Municipal Medical & Preventive Institution Donetsk Regional Clinical Territorial Medical Association
Tetyana Bevzenko

Oleg V. Syniachenko, MD
Principal Investigator
Ukraine Kyiv 2125 State Institution "Institute of Nephrology of AMS of Ukraine"
Valentina Savchuk

Iryna O. Dudar, MD
Principal Investigator
Ukraine Kyiv 04050 State Institution "Institute of Nephrology of AMS of Ukraine"
Maryna Velychko

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
United Kingdom London NW3 2PF Royal Free Hospital
Thirusha Lane
+44 (0) 20 7433 2759

Helen Lachmann, MD
Principal Investigator


Monika Deme, MD

NCT ID: NCT01215747

Date Last Changed: September 8, 2014

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