Trial record 1 of 3 for:
kiacta
Efficacy and Safety Study of KIACTA in Preventing Renal Function Decline in AA Amyloidosis
This study is currently recruiting participants.
Verified February 2013 by C.T. Development America, Inc.
Sponsor:
C.T. Development America, Inc.
Information provided by (Responsible Party):
C.T. Development America, Inc.
ClinicalTrials.gov Identifier:
NCT01215747
First received: October 1, 2010
Last updated: February 28, 2013
Last verified: February 2013
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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: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01215747
Show 76 Study Locations
Contacts
| Contact: Monika Deme, MD | 31630037735 | monika.deme@ppdi.com |
Show 76 Study LocationsSponsors 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: | February 28, 2013 |
| 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 Proteostasis Deficiencies Metabolic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013