AA Amyloidosis MedDRA version: 19.0 Level: PT Classification code 10002022 Term: Amyloidosis System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Product Name: KIACTA
Product Code: NC-503
Pharmaceutical Form: Capsule
INN or Proposed INN: Eprodisate disodium
CAS Number: 36589-58-9
Current Sponsor code: KIACTA
Other descriptive name: NC-503
Conce
Sponsors
A.T. Development Switzerland SARL
Eligibility
Sex/Gender
All
Inclusion criteria
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) no F.1.2.1 Number of subjects for this age range 54 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this open-label extension (OLE) study is to provide access to Kiacta (eprodisate disodium) for those patients who have completed the pivotal, randomized, placebo-controlled Phase 3 Study CL-503012.;Secondary Objective: The secondary objective is to collect data on Kiacta safety and effectiveness in real-life 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None | — |
Countries
Egypt, Lithuania, Peru, Poland, Russian Federation, Tunisia, Ukraine, United Kingdom
Contacts
Public ContactCsaba Kovacs
PPD
Outcome results
None listed