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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by C.T. Development America, Inc.
Sponsor:
Information provided by (Responsible Party):
C.T. Development America, Inc.
ClinicalTrials.gov Identifier:
NCT01215747
First received: October 1, 2010
Last updated: March 21, 2014
Last verified: December 2013

October 1, 2010
March 21, 2014
November 2010
September 2016   (final data collection date for primary outcome measure)
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 ]
all-cause mortality [ Time Frame: Average of 24 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01215747 on ClinicalTrials.gov Archive Site
  • 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 ]
  • persistent decrease in creatinine clearance (CrCl) of 40% or more [ Time Frame: baseline to primary endpoint, measured every 3 months to end of study visit ] [ Designated as safety issue: No ]
  • peristent increase in Serum Creatinine (SCr) of 80% or more [ 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 ]
Not Provided
Not Provided
 
Efficacy and Safety Study of KIACTA in Preventing Renal Function Decline in AA Amyloidosis
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Amyloidosis
  • 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.
  • Drug: Placebo
    Orally 1 to 3 capsules (placebo) twice daily and adjusted as per the Creatine Clearance (CrCl) level increases or decreases:
  • Experimental: Kiacta (eprodisate disodium)
    Intervention: Drug: KIACTA (eprodisate disodium)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
230
September 2016
September 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Monika Deme, MD 31630037735 monika.deme@ppdi.com
United States,   Argentina,   Belgium,   Brazil,   Bulgaria,   Chile,   Czech Republic,   Egypt,   Estonia,   Finland,   France,   Georgia,   Germany,   India,   Israel,   Italy,   Latvia,   Lithuania,   Mexico,   Netherlands,   Peru,   Poland,   Russian Federation,   Spain,   Sweden,   Tunisia,   Turkey,   Ukraine,   United Kingdom
 
NCT01215747
CL-503012
Yes
C.T. Development America, Inc.
C.T. Development America, Inc.
Not Provided
Study Director: Tomasz Sablinski, MD, PhD CT Development America, Inc.
C.T. Development America, Inc.
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP