An extension of the CL-503012 study, which involved an investigation into the safety and efficacy of Kiacta™ in preventing kidney function decline in patients with AA amyloidosis, a disease associated with long-standing inflammatory disease, which can lead to the buildup of protein (amyloid A) inside the kidney and can cause kidney failure

Phase 1

Conditions: AA Amyloidosis
MedDRA version: 17.1Level: PTClassification code 10002022Term: AmyloidosisSystem Organ Class: 10021428 - Immune system disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2013-004150-16-PL

Lead Sponsor: A.T. Development Switzerland SAR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 24

Inclusion Criteria

- Patient has completed Study CL-503012, and has undergone all study assessments that
could affect the primary endpoint of Study CL-503012
- Patient is at least 18 years of age
- Patient has a negative pregnancy test, if a female patient of childbearing potential
- Patient is willing to use effective birth control method. Women of childbearing potential
should continue to use effective birth control method as follows:
- Oral contraception with an additional barrier method (since the investigational
product may impair effectiveness of oral contraception)
- Double-barrier method (diaphragm with spermicidal gel or condom with
contraceptive foam)
- Transdermal or long-acting injected contraceptive (e.g., depot
medroxyprogesterone acetate [Depo-Provera®])
- Intrauterine device or implantable contraceptive
- Partner who is surgically sterile (vasectomy)
- Total abstinence
Nonsurgically sterile men should use double-barrier method as described above during
intercourse for the duration of the treatment with Kiacta.
- Patient has provided written informed consent to participate in this OLE study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

- Patient has a CrCl =15 mL/min (as estimated by the Cockcroft-Gault formula prior to
entering into the program
- Patient has liver enzyme values (aspartate aminotransferase, alanine aminotransferase, or
alkaline phosphatase) >5 times the upper limit of normal and/or total bilirubin >50%
higher than the upper limit of normal
- Patient progressed to ESRD during Study CL-503012. In Study CL-503012 ESRD was
defined as one of the following:
i. Presence of Stage 5 chronic kidney disease, i.e., established kidney failure
with an eGFR <15 mL/min, obtained from 2 distinct SCr measurements
separated by 2 to 4 weeks (Visit X and Visit X plus 2 to 4 weeks) or
ii. Initiation of permanent renal replacement therapy, defined as a need for
chronic dialysis (duration of 3 months or more) or transplantation
- Patient was noncompliant while in Study CL-503012
- Patient prematurely withdrawn from Study CL-503012
- Patient has a clinically significant disease that could compromise patient’s safety
- Patient suffers from active alcohol and/or drug abuse
- Patient is pregnant or lactating, or patient is a woman of childbearing potential and is
unwilling to use a clinically approved form of contraception during the program
(continuous use of oral or long-acting injected contraceptive and/or use of an intra-uterine
device or implantable contraceptive, and/or use of a barrier method of birth control)
- Patient was on other investigational drug(s) given within 30 days prior to entry into this
program or during this program (with the exception of study drug taken in previous
CL-50312 program

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this open-label extension (OLE) study is to provide access to Kiacta<br>(eprodisate disodium) for those patients who have completed the pivotal, randomized,<br>placebo-controlled Phase 3 Study CL-503012.;Secondary Objective: The secondary objective is to collect data on Kiacta safety and effectiveness in real-life<br>situations.;Primary end point(s): Collection of data on Kiacta safety and effectiveness in real-life situations;Timepoint(s) of evaluation of this end point: 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None

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