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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

  Show 49 Study Locations
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