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

NCT01215747 | Completed Phase 3 DMC

• 1 other identifier: CL-503012
• Study Type: interventional
• Target: 261
• Locations: 21 countries
• Sites: 41

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.

Conditions

Amyloidosis

Keywords

Kiacta for AA amyloidosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• 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

• 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

Study Arms (2)

Kiacta (eprodisate disodium)

EXPERIMENTAL

Drug: KIACTA (eprodisate disodium)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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.

Kiacta (eprodisate disodium)

Placebo DRUG

Orally 1 to 3 capsules (placebo) twice daily and adjusted as per the Creatine Clearance (CrCl) level increases or decreases:

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• C.T. Development America, Inc.: lead

Study Sites (46)

Raffi Minasian MD a Medical Corporation

Glendale, California, 91204, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Al Hussain University Hospital

Cairo, 11214, Egypt

Location

Tartu University Hospital

Tartu, EE-51014, Estonia

Location

Helsingin yliopistollinen keskussairaala / Meilahti

Helsinki, FI-00290, Finland

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

Hôpital Claude Huriez

Lille, 59037, France

Location

Tbilisi Heart and Vascular Clinic Ltd

Tbilisi, 0159, Georgia

Location

Universität Heidelberg

Heidelberg, 69120, Germany

Location

Regency Hospital

Kanpur, 208005, India

Location

Muljibhai Patel Urological Hospital

Nadiād, 387001, India

Location

Sir Ganga Ram Hospital

New Delhi, 110060, India

Location

Bnei Zion Medical Center

Haifa, 31048, Israel

Location

The Chaim Sheba Medical Center

Ramat Gan, 52621, Israel

Location

IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Pauls Stradins Clinical University Hospital

Riga, LV-1002, Latvia

Location

Hospital of Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, LT-50009, Lithuania

Location

Vilnius University Hospital Santariskiu Klinikos

Vilnius, LT-08661, Lithuania

Location

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6229 Hx, Netherlands

Location

Hospital Nacional Arzobispo Loayza

Lima, Lima 1, Peru

Location

Wojewodzki Szpital Specjalistyczny

Olsztyn, 10-561, Poland

Location

ARS RHEUMATICA Sp. z o.o.

Warsaw, 02-653, Poland

Location

Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

Wroclaw, 50-556, Poland

Location

Kemerovo State Medical Academy of Roszdrav

Kemerovo, 650066, Russia

Location

Institute of Rheumatology of RAMN

Moscow, 115522, Russia

Location

Research Institute of Clinical and Experimental Lymphology

Novosibirsk, 630117, Russia

Location

Sverdlovsk Regional Clinical Hospital #1

Yekaterinburg, 620102, Russia

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Civil Carlos Haya

Málaga, 29009, Spain

Location

Karolinska Universitetssjukhuset i Huddinge

Stockholm, SE-14186, Sweden

Location

Fattouma Bourguiba University Hospital

Monastir, 5000, Tunisia

Location

Hedi Chaker University Hospital

Sfax, 3029, Tunisia

Location

Sahloul Hospital

Sousse, 4020, Tunisia

Location

Hôpital Charles Nicolle

Tunis, 1006, Tunisia

Location

La Rabta Hospital

Tunis, 1007, Tunisia

Location

Cukurova University Medical Faculty Balcali Hospital

Adana, 01330, Turkey (Türkiye)

Location

Hacettepe University Medical Faculty

Ankara, 06100, Turkey (Türkiye)

Location

Eskisehir Osmangazi University Medical Faculty

Eskişehir, 26480, Turkey (Türkiye)

Location

Municipal Medical & Preventive Institution Donetsk Regional Clinical Territorial Medical Association

Donetsk, 83003, Ukraine

Location

National Scientific Center "Institute of cardiology n.a. academician M.D Strazhesko"

Kyiv, 03680, Ukraine

Location

State Institution "Institute of Nephrology of AMS of Ukraine"

Kyiv, 04050, Ukraine

Location

State Institution "Institute of Nephrology of AMS of Ukraine"

Kyiv, 2125, Ukraine

Location

Royal Free Hospital

London, NW3 2PF, United Kingdom

Location

MeSH Terms

Conditions

Amyloidosis

Interventions

eprodisate

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Tomasz Sablinski, MD, PhD

  CT Development America, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2010
• First Posted: October 6, 2010
• Study Start: November 1, 2010
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 10, 2016

Record last verified: 2016-03

Locations

IL (2); FI (1); PE (1); BE (1); RU (4); ES (1); TU (5); DE (1); PL (3); SE (1); US (3); IT (1); LA (1); EG (1); UA (4); GE (1); FR (2); NL (2); IN (3); LI (2); GB (1)