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

Primary Purpose

Amyloidosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
KIACTA (eprodisate disodium)
Placebo
Sponsored by
C.T. Development America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Amyloidosis focused on measuring Kiacta for AA amyloidosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Raffi Minasian MD a Medical Corporation
  • Boston Medical Center
  • Ohio State University Medical Center
  • UZ Leuven
  • Al Hussain University Hospital
  • Tartu University Hospital
  • Helsingin yliopistollinen keskussairaala / Meilahti
  • Hôpital Henri Mondor
  • Hôpital Claude Huriez
  • Tbilisi Heart and Vascular Clinic Ltd
  • Universität Heidelberg
  • Regency Hospital
  • Muljibhai Patel Urological Hospital
  • Sir Ganga Ram Hospital
  • Bnei Zion Medical Center
  • The Chaim Sheba Medical Center
  • IRCCS Policlinico San Matteo
  • Pauls Stradins Clinical University Hospital
  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
  • Vilnius University Hospital Santariskiu Klinikos
  • Universitair Medisch Centrum Groningen
  • Academisch Ziekenhuis Maastricht
  • Hospital Nacional Arzobispo Loayza
  • Wojewodzki Szpital Specjalistyczny
  • ARS RHEUMATICA Sp. z o.o.
  • Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
  • Sverdlovsk Regional Clinical Hospital #1
  • Kemerovo State Medical Academy of Roszdrav
  • Institute of Rheumatology of RAMN
  • Research Institute of Clinical and Experimental Lymphology
  • Hospital Clinic de Barcelona
  • Hospital Civil Carlos Haya
  • Karolinska Universitetssjukhuset i Huddinge
  • Fattouma Bourguiba University Hospital
  • Hedi Chaker University Hospital
  • Sahloul Hospital
  • Hôpital Charles Nicolle
  • La Rabta Hospital
  • Cukurova University Medical Faculty Balcali Hospital
  • Hacettepe University Medical Faculty
  • Eskisehir Osmangazi University Medical Faculty
  • Municipal Medical & Preventive Institution Donetsk Regional Clinical Territorial Medical Association
  • National Scientific Center "Institute of cardiology n.a. academician M.D Strazhesko"
  • State Institution "Institute of Nephrology of AMS of Ukraine"
  • State Institution "Institute of Nephrology of AMS of Ukraine"
  • Royal Free Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Kiacta (eprodisate disodium)

Placebo

Arm Description

Outcomes

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)

Secondary Outcome Measures

rate of change (slope) in creatinine clearance (CrCL) over time
Progression to end-stage renal disease (ESRD)
estimated glomerular filtration rate (eGFR)
serum cystatin C over time
urinary protein/creatinine ratio
serum amyloid A
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

Full Information

First Posted
October 1, 2010
Last Updated
March 9, 2016
Sponsor
C.T. Development America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01215747
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
C.T. Development America, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyloidosis
Keywords
Kiacta for AA amyloidosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
261 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kiacta (eprodisate disodium)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
KIACTA (eprodisate disodium)
Intervention Description
Orally 1 to 3 capsules (Kiacta 400 mg) twice daily and adjusted as per the Creatine Clearance (CrCl) level increases or decreases.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Orally 1 to 3 capsules (placebo) twice daily and adjusted as per the Creatine Clearance (CrCl) level increases or decreases:
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Progression to end-stage renal disease (ESRD)
Time Frame
baseline, every 3 months to end of study visit
Title
estimated glomerular filtration rate (eGFR)
Time Frame
screening, baseline, every 3 months, 12 months , early termination, treatment completion, end of study visit
Title
serum cystatin C over time
Time Frame
baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit
Title
urinary protein/creatinine ratio
Time Frame
screening, baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit
Title
serum amyloid A
Time Frame
baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomasz Sablinski, MD, PhD
Organizational Affiliation
CT Development America, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Raffi Minasian MD a Medical Corporation
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Al Hussain University Hospital
City
Cairo
ZIP/Postal Code
11214
Country
Egypt
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
EE-51014
Country
Estonia
Facility Name
Helsingin yliopistollinen keskussairaala / Meilahti
City
Helsinki
ZIP/Postal Code
FI-00290
Country
Finland
Facility Name
Hôpital Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Hôpital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Tbilisi Heart and Vascular Clinic Ltd
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Universität Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Regency Hospital
City
Kanpur
ZIP/Postal Code
208005
Country
India
Facility Name
Muljibhai Patel Urological Hospital
City
Nadiad
ZIP/Postal Code
387001
Country
India
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Bnei Zion Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Ramat-Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
Vilnius University Hospital Santariskiu Klinikos
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Academisch Ziekenhuis Maastricht
City
Maastricht
ZIP/Postal Code
6229 Hx
Country
Netherlands
Facility Name
Hospital Nacional Arzobispo Loayza
City
Lima
ZIP/Postal Code
Lima 1
Country
Peru
Facility Name
Wojewodzki Szpital Specjalistyczny
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
ARS RHEUMATICA Sp. z o.o.
City
Warszawa
ZIP/Postal Code
02-653
Country
Poland
Facility Name
Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Sverdlovsk Regional Clinical Hospital #1
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Kemerovo State Medical Academy of Roszdrav
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
Institute of Rheumatology of RAMN
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Research Institute of Clinical and Experimental Lymphology
City
Novosibirsk
ZIP/Postal Code
630117
Country
Russian Federation
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Civil Carlos Haya
City
Malaga
ZIP/Postal Code
29009
Country
Spain
Facility Name
Karolinska Universitetssjukhuset i Huddinge
City
Stockholm
ZIP/Postal Code
SE-14186
Country
Sweden
Facility Name
Fattouma Bourguiba University Hospital
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia
Facility Name
Hedi Chaker University Hospital
City
Sfax
ZIP/Postal Code
3029
Country
Tunisia
Facility Name
Sahloul Hospital
City
Sousse
ZIP/Postal Code
4020
Country
Tunisia
Facility Name
Hôpital Charles Nicolle
City
Tunis
ZIP/Postal Code
1006
Country
Tunisia
Facility Name
La Rabta Hospital
City
Tunis
ZIP/Postal Code
1007
Country
Tunisia
Facility Name
Cukurova University Medical Faculty Balcali Hospital
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Eskisehir Osmangazi University Medical Faculty
City
Eskisehir
ZIP/Postal Code
26480
Country
Turkey
Facility Name
Municipal Medical & Preventive Institution Donetsk Regional Clinical Territorial Medical Association
City
Donetsk
ZIP/Postal Code
83003
Country
Ukraine
Facility Name
National Scientific Center "Institute of cardiology n.a. academician M.D Strazhesko"
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
State Institution "Institute of Nephrology of AMS of Ukraine"
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
State Institution "Institute of Nephrology of AMS of Ukraine"
City
Kyiv
ZIP/Postal Code
2125
Country
Ukraine
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2PF
Country
United Kingdom

12. IPD Sharing Statement

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

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