Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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21 July 2016 |
Main ID: |
EUCTR2013-004150-16-LT |
Date of registration:
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07/04/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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
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Scientific title:
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International Open-Label Extension of the Phase 3 Study CL-503012 with KIACTA™ in Patients with AA Amyloidosis |
Date of first enrolment:
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19/06/2014 |
Target sample size:
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70 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004150-16 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
Number of treatment arms in the trial: 1
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Egypt
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Lithuania
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Peru
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Poland
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Russian Federation
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Tunisia
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Ukraine
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United Kingdom
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Contacts
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Name:
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Csaba Kovacs
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Address:
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Bocskai ut 134-146
1113
Budapest
Hungary |
Telephone:
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3613819575 |
Email:
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Csaba.Kovacs@ppdi.com |
Affiliation:
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PPD |
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Name:
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Csaba Kovacs
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Address:
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Bocskai ut 134-146
1113
Budapest
Hungary |
Telephone:
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3613819575 |
Email:
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Csaba.Kovacs@ppdi.com |
Affiliation:
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PPD |
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Key inclusion & exclusion criteria
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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: - 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
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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AA Amyloidosis MedDRA version: 19.0
Level: PT
Classification code 10002022
Term: Amyloidosis
System Organ Class: 10021428 - Immune system disorders
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Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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Intervention(s)
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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 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400-
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Primary Outcome(s)
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Secondary Objective: The secondary objective is to collect data on Kiacta safety and effectiveness in real-life situations.
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Primary end point(s): Collection of data on Kiacta safety and effectiveness in real-life situations
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Timepoint(s) of evaluation of this end point: 12 months
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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.
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: None
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Secondary end point(s): None
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Secondary ID(s)
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CL-503015
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Source(s) of Monetary Support
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A.T. Development Switzerland SARL
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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