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

NCT01215747 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 261

Last updated 2016-03-10

No results posted yet for this study

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

  • Amyloidosis

Interventions

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:

Sponsors & Collaborators

  • C.T. Development America, Inc.

    lead INDUSTRY

Principal Investigators

  • Tomasz Sablinski, MD, PhD · CT Development America, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2016-01-31
Completion
2016-03-31

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

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01215747 on ClinicalTrials.gov