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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
C.T. Development America, Inc.
ClinicalTrials.gov Identifier:
NCT01215747
First received: October 1, 2010
Last updated: November 3, 2014
Last verified: September 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01215747

  Hide Study Locations
Locations
United States, California
Raffi Minasian MD a Medical Corporation
Glendale, California, United States, 91204
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Belgium
UZ Leuven
Leuven, Belgium, 3000
Egypt
Al Hussain University Hospital
Cairo, Egypt, 11214
Sayed Galal University Hospital
Cairo, Egypt
Estonia
Tartu University Hospital
Tartu, Estonia, EE-51014
Finland
Helsingin yliopistollinen keskussairaala / Meilahti
Helsinki, Finland, FI-00290
France
Hôpital Henri Mondor
Creteil, France, 94010
Hôpital Claude Huriez
Lille, France, 59037
Georgia
Tbilisi Heart and Vascular Clinic Ltd
Tbilisi, Georgia, 0159
Germany
Universität Heidelberg
Heidelberg, Germany, 69120
India
Regency Hospital
Kanpur, India, 208005
Muljibhai Patel Urological Hospital
Nadiad, India, 387001
Sir Ganga Ram Hospital
New Delhi, India, 110060
Israel
Bnei Zion Medical Center
Haifa, Israel, 31048
The Chaim Sheba Medical Center
Ramat-Gan, Israel, 52621
Italy
Azienda Ospedaliero-Universitaria di Modena Policlinico
Modena, Italy, 41100
IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Latvia
Pauls Stradins Clinical University Hospital
Riga, Latvia, LV-1002
Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, Lithuania, LT-50009
Vilnius University Hospital Santariskiu Klinikos
Vilnius, Lithuania, LT-08661
Mexico
Centenario Hospital Miguel Hidalgo
Aguascalientes, Mexico, 20230
Netherlands
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9713 GZ
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands, 6229 Hx
Peru
Hospital Nacional Arzobispo Loayza
Lima, Peru, Lima 1
Poland
Wojewodzki Szpital Specjalistyczny
Olsztyn, Poland, 10-561
ARS RHEUMATICA Sp. z o.o.
Warszawa, Poland, 02-653
Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, Poland, 50-556
Russian Federation
Sverdlovsk Regional Clinical Hospital #1
Ekaterinburg, Russian Federation, 620102
Kemerovo State Medical Academy of Roszdrav
Kemerovo, Russian Federation, 650066
Institute of Rheumatology of RAMN
Moscow, Russian Federation, 115522
Research Institute of Clinical and Experimental Lymphology
Novosibirsk, Russian Federation, 630117
Spain
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Hospital Civil Carlos Haya
Malaga, Spain, 29009
Sweden
Karolinska Universitetssjukhuset i Huddinge
Stockholm, Sweden, SE-14186
Tunisia
Fattouma Bourguiba University Hospital
Monastir, Tunisia, 5000
Hedi Chaker University Hospital
Sfax, Tunisia, 3029
Sahloul Hospital
Sousse, Tunisia, 4020
Hôpital Charles Nicolle
Tunis, Tunisia, 1006
La Rabta Hospital
Tunis, Tunisia, 1007
Turkey
Cukurova University Medical Faculty Balcali Hospital
Adana, Turkey, 01330
Hacettepe University Medical Faculty
Ankara, Turkey, 06100
Eskisehir Osmangazi University Medical Faculty
Eskisehir, Turkey, 26480
Ukraine
Municipal Medical & Preventive Institution Donetsk Regional Clinical Territorial Medical Association
Donetsk, Ukraine, 83003
National Scientific Center "Institute of cardiology n.a. academician M.D Strazhesko"
Kyiv, Ukraine, 03680
State Institution "Institute of Nephrology of AMS of Ukraine"
Kyiv, Ukraine, 04050
State Institution "Institute of Nephrology of AMS of Ukraine"
Kyiv, Ukraine, 2125
United Kingdom
Royal Free Hospital
London, United Kingdom, NW3 2PF
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: November 3, 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
Metabolic Diseases
Proteostasis Deficiencies

ClinicalTrials.gov processed this record on November 20, 2014