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

Phase 3

Completed

• Conditions: Amyloidosis
• Interventions: Drug: Placebo; Drug: KIACTA (eprodisate disodium)

• Registration Number: NCT01215747
• Lead Sponsor: C.T. Development America, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-01
• Study First Submitted QC: 2010-10-05
• Study First Posted: 2010-10-06
• Study Start: 2010-11
• Primary Completion: 2016-01
• Status Verified: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-09
• Last Update Posted: 2016-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 261

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Kiacta (eprodisate disodium)	KIACTA (eprodisate disodium)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
urinary protein/creatinine ratio	screening, baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit
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	Up to 24 months
serum amyloid A	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
rate of change (slope) in creatinine clearance (CrCL) over time	baseline to primary endpoint, measured 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
Progression to end-stage renal disease (ESRD)	baseline, every 3 months to end of study visit

Trial Locations

Locations (45)

Raffi Minasian MD a Medical Corporation; 🇺🇸 Glendale, California, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States

UZ Leuven; 🇧🇪 Leuven, Belgium

Al Hussain University Hospital; 🇪🇬 Cairo, Egypt

Tartu University Hospital; 🇪🇪 Tartu, Estonia

Helsingin yliopistollinen keskussairaala / Meilahti; 🇫🇮 Helsinki, Finland

Hôpital Henri Mondor; 🇫🇷 Creteil, France

Hôpital Claude Huriez; 🇫🇷 Lille, France

Tbilisi Heart and Vascular Clinic Ltd; 🇬🇪 Tbilisi, Georgia

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