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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kiacta (eprodisate disodium) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KIACTA (eprodisate disodium) | Drug | Orally 1 to 3 capsules (Kiacta 400 mg) twice daily and adjusted as per the Creatine Clearance (CrCl) level increases or decreases. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| rate of change (slope) in creatinine clearance (CrCL) over time | baseline to primary endpoint, measured every 3 months to end of study visit | |
| Progression to end-stage renal disease (ESRD) | baseline, every 3 months to end of study visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomasz Sablinski, MD, PhD | CT Development America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raffi Minasian MD a Medical Corporation | Glendale | California | 91204 | United States | ||
| Boston Medical Center |
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| Placebo | Drug | Orally 1 to 3 capsules (placebo) twice daily and adjusted as per the Creatine Clearance (CrCl) level increases or decreases: |
|
| estimated glomerular filtration rate (eGFR) | screening, baseline, every 3 months, 12 months , early termination, treatment completion, end of study visit |
| serum cystatin C over time | baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit |
| urinary protein/creatinine ratio | screening, baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit |
| serum amyloid A | baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit |
| 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 | Up to 24 months |
| Boston |
| Massachusetts |
| 02118 |
| United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| UZ Leuven | Leuven | 3000 | Belgium |
| Al Hussain University Hospital | Cairo | 11214 | Egypt |
| Tartu University Hospital | Tartu | EE-51014 | Estonia |
| Helsingin yliopistollinen keskussairaala / Meilahti | Helsinki | FI-00290 | Finland |
| Hôpital Henri Mondor | Créteil | 94010 | France |
| Hôpital Claude Huriez | Lille | 59037 | France |
| Tbilisi Heart and Vascular Clinic Ltd | Tbilisi | 0159 | Georgia |
| Universität Heidelberg | Heidelberg | 69120 | Germany |
| Regency Hospital | Kanpur | 208005 | India |
| Muljibhai Patel Urological Hospital | Nadiād | 387001 | India |
| Sir Ganga Ram Hospital | New Delhi | 110060 | India |
| Bnei Zion Medical Center | Haifa | 31048 | Israel |
| The Chaim Sheba Medical Center | Ramat Gan | 52621 | Israel |
| IRCCS Policlinico San Matteo | Pavia | 27100 | Italy |
| Pauls Stradins Clinical University Hospital | Riga | LV-1002 | Latvia |
| Hospital of Lithuanian University of Health Sciences Kaunas Clinics | Kaunas | LT-50009 | Lithuania |
| Vilnius University Hospital Santariskiu Klinikos | Vilnius | LT-08661 | Lithuania |
| Universitair Medisch Centrum Groningen | Groningen | 9713 GZ | Netherlands |
| Academisch Ziekenhuis Maastricht | Maastricht | 6229 Hx | Netherlands |
| Hospital Nacional Arzobispo Loayza | Lima | Lima 1 | Peru |
| Wojewodzki Szpital Specjalistyczny | Olsztyn | 10-561 | Poland |
| ARS RHEUMATICA Sp. z o.o. | Warsaw | 02-653 | Poland |
| Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu | Wroclaw | 50-556 | Poland |
| Kemerovo State Medical Academy of Roszdrav | Kemerovo | 650066 | Russia |
| Institute of Rheumatology of RAMN | Moscow | 115522 | Russia |
| Research Institute of Clinical and Experimental Lymphology | Novosibirsk | 630117 | Russia |
| Sverdlovsk Regional Clinical Hospital #1 | Yekaterinburg | 620102 | Russia |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Civil Carlos Haya | Málaga | 29009 | Spain |
| Karolinska Universitetssjukhuset i Huddinge | Stockholm | SE-14186 | Sweden |
| Fattouma Bourguiba University Hospital | Monastir | 5000 | Tunisia |
| Hedi Chaker University Hospital | Sfax | 3029 | Tunisia |
| Sahloul Hospital | Sousse | 4020 | Tunisia |
| Hôpital Charles Nicolle | Tunis | 1006 | Tunisia |
| La Rabta Hospital | Tunis | 1007 | Tunisia |
| Cukurova University Medical Faculty Balcali Hospital | Adana | 01330 | Turkey (Türkiye) |
| Hacettepe University Medical Faculty | Ankara | 06100 | Turkey (Türkiye) |
| Eskisehir Osmangazi University Medical Faculty | Eskişehir | 26480 | Turkey (Türkiye) |
| Municipal Medical & Preventive Institution Donetsk Regional Clinical Territorial Medical Association | Donetsk | 83003 | Ukraine |
| National Scientific Center "Institute of cardiology n.a. academician M.D Strazhesko" | Kyiv | 03680 | Ukraine |
| State Institution "Institute of Nephrology of AMS of Ukraine" | Kyiv | 04050 | Ukraine |
| State Institution "Institute of Nephrology of AMS of Ukraine" | Kyiv | 2125 | Ukraine |
| Royal Free Hospital | London | NW3 2PF | United Kingdom |
| ID | Term |
|---|---|
| D000686 | Amyloidosis |
| ID | Term |
|---|---|
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C520274 | eprodisate |
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