Trials / Completed
CompletedNCT01215747
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 261 (actual)
- Sponsor
- C.T. Development America, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose of this study is to assess the efficacy and safety of treatment with Kiacta in adult patients with AA Amyloidosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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: |
Timeline
- Start date
- 2010-11-01
- Primary completion
- 2016-01-01
- Completion
- 2016-03-01
- First posted
- 2010-10-06
- Last updated
- 2016-03-10
Locations
46 sites across 23 countries: United States, Belgium, Egypt, Estonia, Finland, France, Georgia, Germany, India, Israel, Italy, Latvia, Lithuania, Netherlands, Peru, Poland, Russia, Spain, Sweden, Tunisia, Turkey (Türkiye), Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT01215747. Inclusion in this directory is not an endorsement.