AmyloidosisPhase 3NCT01215747
Efficacy and Safety Study of KIACTA in Preventing Renal Function Decline in AA Amyloidosis
A Phase 3 study testing KIACTA (eprodisate disodium) in people with Amyloidosis, run by C.T. Development America, Inc. at 46 sites in 23 countries.
Trial summary
The primary purpose of this study is to assess the efficacy and safety of treatment with Kiacta in adult patients with AA Amyloidosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyloidosis
- What is being tested?
- KIACTA (eprodisate disodium)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 261 participants
- Where
- 46 sitesin 23 countries
- Study dates
- Nov 2010to Mar 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- females must be of nonchildbearing potential (more than 1 yr postmenopausal)or use effective contraception for at least 2 months prior to the baseline visit and through 30 days after the last dose of study medication
- confirmed diagnosis of AA amyloidosis demonstrated by positive biopsy using congo red staining and immunohistochemistry or immunoelectronmicroscopy. Mass spectroscopy will be used upon approval of the sponsor on a case to case basis.
- persistent proteinuria greater than 1 g/24h at 2 distinct 24-hr urine collections
- must have CrCl greater than 25 ml/min/1.73 m2 at 2 distinct 24 hr urine collections
Who cannot join
- evidence or suspicion of chronic kidney disease secondary to a disease other than AA amyloidosis (eg, diabetes, long-standing uncontrolled hypertension, polycystic kidney disease, recurring polynephritis, or systemic lupus erythematosus)
- history of kidney transplantation
- evidence or suspicion of a cause of potentially reversible acute renal failure within 3 months prior to baseline visit
- presence of concomitant diseases or medication that could interfere with the interpretation of study results or compromise patient safety
- presence of condition that could reduce life expectancy to less than 2 yrs
- Type 1 or 2 diabetes mellitus
Show all 15Show fewer
- significant hepatic enzyme elevation
- unstable angina, myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty within 6 months prior to the baseline visit; presence of NY Heart Assoc class III or IV heart failure
- presence of, or history of stroke or transient ischemic attack within 6 months prior to baseline visit
- initiation of, or any changes in, angiotensin converting enzyme inhibitor, angiotensin II receptor antagonist therapy, or renin inhibitor within 3 months prior to baseline visit
- initiation of, or any changes in, cytotoxic agents, anti-tumor necrosis factor agents, anti interleukin-1 or 6 agents, or colchicine therapy within 3 months prior to baseline visit
- previous use of Kiacta
- history of malignancy within 5 yrs prior to study entry, except for cervical carcinoma in situ, nonmelanomatous carcinoma of the skin, or ductal carcinoma in situ of the breast that has been surgically cured
- use of investigational drug within 30 days prior to the first screening visit
- active alcohol and/or drug abuse
Trial locations and contacts
46 sites in 23 countries.
46 sites in 23 countries
Tunisia5 sites
Fattouma Bourguiba University Hospital
Monastir, 5000
Hedi Chaker University Hospital
Sfax, 3029
Sahloul Hospital
Sousse, 4020
Hôpital Charles Nicolle
Tunis, 1006
La Rabta Hospital
Tunis, 1007
Russia4 sites
Kemerovo State Medical Academy of Roszdrav
Kemerovo, 650066
Institute of Rheumatology of RAMN
Moscow, 115522
Research Institute of Clinical and Experimental Lymphology
Novosibirsk, 630117
Sverdlovsk Regional Clinical Hospital #1
Yekaterinburg, 620102
Ukraine4 sites
Municipal Medical & Preventive Institution Donetsk Regional Clinical Territorial Medical Association
Donetsk, 83003
National Scientific Center "Institute of cardiology n.a. academician M.D Strazhesko"
Kyiv, 03680
State Institution "Institute of Nephrology of AMS of Ukraine"
Kyiv, 04050
State Institution "Institute of Nephrology of AMS of Ukraine"
Kyiv, 2125
United States3 sites
Boston Medical Center
Boston, Massachusetts, 02118
Ohio State University Medical Center
Columbus, Ohio, 43210
Raffi Minasian MD a Medical Corporation
Glendale, California, 91204
India3 sites
Regency Hospital
Kanpur, 208005
Muljibhai Patel Urological Hospital
Nadiād, 387001
Sir Ganga Ram Hospital
New Delhi, 110060
Poland3 sites
Wojewodzki Szpital Specjalistyczny
Olsztyn, 10-561
ARS RHEUMATICA Sp. z o.o.
Warsaw, 02-653
Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, 50-556
Turkey (Türkiye)3 sites
Cukurova University Medical Faculty Balcali Hospital
Adana, 01330
Hacettepe University Medical Faculty
Ankara, 06100
Eskisehir Osmangazi University Medical Faculty
Eskişehir, 26480
France2 sites
Hôpital Henri Mondor
Créteil, 94010
Hôpital Claude Huriez
Lille, 59037
Israel2 sites
Bnei Zion Medical Center
Haifa, 31048
The Chaim Sheba Medical Center
Ramat Gan, 52621
Lithuania2 sites
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, LT-50009
Vilnius University Hospital Santariskiu Klinikos
Vilnius, LT-08661
Netherlands2 sites
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
Academisch Ziekenhuis Maastricht
Maastricht, 6229 Hx
Spain2 sites
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Civil Carlos Haya
Málaga, 29009
Finland1 site
Helsingin yliopistollinen keskussairaala / Meilahti
Helsinki, FI-00290
About this study
Official title: 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
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
- Being tested
- KIACTA (eprodisate disodium), Placebo
- Keywords
- Kiacta for AA amyloidosis
- Medical subject headings
- Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KIACTA (eprodisate disodium)Drug
Orally 1 to 3 capsules (Kiacta 400 mg) twice daily and adjusted as per the Creatine Clearance (CrCl) level increases or decreases.
PlaceboDrug
Orally 1 to 3 capsules (placebo) twice daily and adjusted as per the Creatine Clearance (CrCl) level increases or decreases:
| Study group | Role | What they receive |
|---|---|---|
| Kiacta (eprodisate disodium) | Experimental | Not described Receives: Drug: KIACTA (eprodisate disodium) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from baseline to a persistent decrease in Creatinine clearance (CrCL) of 40% or more, a persistent increase in Serum Creatinine(SCr) of 80% or more, or progression to end-stage renal disease(ESRD)
Measured: Up to 24 months
Secondary outcomes (7)
rate of change (slope) in creatinine clearance (CrCL) over time
Measured: baseline to primary endpoint, measured every 3 months to end of study visit
Progression to end-stage renal disease (ESRD)
Measured: baseline, every 3 months to end of study visit
estimated glomerular filtration rate (eGFR)
Measured: screening, baseline, every 3 months, 12 months , early termination, treatment completion, end of study visit
serum cystatin C over time
Measured: baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit
urinary protein/creatinine ratio
Measured: screening, baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit
serum amyloid A
Measured: baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit
Time from baseline to persistent decrease in CrCL of 40% or more, a persistent increase in SCr of 80% or more, progression to ESRD, or all-cause mortality
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmyloidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- C.T. Development America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tomasz Sablinski, MD, PhD, Study director, CT Development America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215747
- Sponsor's protocol ID
- CL-503012
- Status last verified
- Mar 2016
- First submitted
- 1 Oct 2010
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01215747
- Acronym / sponsor ID
- CL-503012
- Conditions
- Amyloidosis
- Keywords
- Kiacta for AA amyloidosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- C.T. Development America, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 6 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to assess the efficacy and safety of treatment with Kiacta in adult patients with AA Amyloidosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kiacta (eprodisate disodium) | Experimental | Drug: KIACTA (eprodisate disodium) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- females must be of nonchildbearing potential (more than 1 yr postmenopausal)or use effective contraception for at least 2 months prior to the baseline visit and through 30 days after the last dose of study medication
- confirmed diagnosis of AA amyloidosis demonstrated by positive biopsy using congo red staining and immunohistochemistry or immunoelectronmicroscopy. Mass spectroscopy will be used upon approval of the sponsor on a case to case basis.
- persistent proteinuria greater than 1 g/24h at 2 distinct 24-hr urine collections
- must have CrCl greater than 25 ml/min/1.73 m2 at 2 distinct 24 hr urine collections
Key exclusion criteria (15 listed)
- evidence or suspicion of chronic kidney disease secondary to a disease other than AA amyloidosis (eg, diabetes, long-standing uncontrolled hypertension, polycystic kidney disease, recurring polynephritis, or systemic lupus erythematosus)
- history of kidney transplantation
- evidence or suspicion of a cause of potentially reversible acute renal failure within 3 months prior to baseline visit
- presence of concomitant diseases or medication that could interfere with the interpretation of study results or compromise patient safety
- presence of condition that could reduce life expectancy to less than 2 yrs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Kiacta (eprodisate disodium) |
| PlaceboOrally 1 to 3 capsules (placebo) twice daily and adjusted as per the Creatine Clearance (CrCl) level increases or decreases: | Drug | Placebo |
Primary outcome
Time from baseline to a persistent decrease in Creatinine clearance (CrCL) of 40% or more, a persistent increase in Serum Creatinine(SCr) of 80% or more, or progression to end-stage renal disease(ESRD)
Time frame: Up to 24 months
7 secondary outcomes
rate of change (slope) in creatinine clearance (CrCL) over time
Time frame: baseline to primary endpoint, measured every 3 months to end of study visit
Progression to end-stage renal disease (ESRD)
Time frame: baseline, every 3 months to end of study visit
estimated glomerular filtration rate (eGFR)
Time frame: screening, baseline, every 3 months, 12 months , early termination, treatment completion, end of study visit
serum cystatin C over time
Time frame: baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit
urinary protein/creatinine ratio
Time frame: screening, baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit
serum amyloid A
Time frame: baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit
Time from baseline to persistent decrease in CrCL of 40% or more, a persistent increase in SCr of 80% or more, progression to ESRD, or all-cause mortality
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomasz Sablinski, MD, PhD study director
CT Development America, Inc.
46 sites in 23 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KIACTA (eprodisate disodium) in people with Amyloidosis, run by C.T. Development America, Inc. at 46 sites in 23 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Tunisia, Russia, Ukraine, United States, India and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from baseline to a persistent decrease in Creatinine clearance (CrCL) of 40% or more, a persistent increase in Serum Creatinine(SCr) of 80% or more, or progression to end-stage renal disease(ESRD) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2016.