Chronic Kidney DiseasePhase 4K-STARNCT00860431
Kremezin Study Against Renal Disease Progression in Korea
A Phase 4 study testing AST-120 in people with Chronic Kidney Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
1. To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) added to standard-of-care therapy in moderate to severe Chronic Kidney Disease (CKD III-IV), on time to first occurrence of any event of the triple composite outcome of initiation of renal replacement therapy, decline of eGFR 50% or more or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- AST-120
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 578 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2009to Sep 2013
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Age 18 years or older
- CKD stage 3,4 (estimated GFR by Cockcroft-Gault equation 15-59 mL/min/1.73m^2)
- Followed up by responsible nephrologists more than 6 months
- eGFR checked 2 times or more during screening period
- eGFR declined or expected to decline >= 5mL/min/year or >=2.5mL/min/6 months
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- Blood pressure <= 160/100 mmHg
- Blood pressure checked 3 times or more during screening period
- No significant change of medication for CKD
Who cannot join
- Patients who took medicine AST-120 or ketosteril within 2 months
- Received any investigational agent or participated in a clinical study within the previous 2 months
- History of gastrointestinal disease (active gastric ulcer, inflammatory bowel disease, hiatal hernia, or severe GI dysmotility)
- obstructive urologic disease and other reversible kidney diseases
- chronic kidney disease due to autosomal dominant polycystic kidney disease, ADPKD
- severe nephrotic syndrome, 10g or more/day(or random urine pCR >= 10.0)
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- History of previous kidney transplant
- Heart failure (NYHA III-IV), uncontrolled arrhythmia, unstable angina
- Liver cirrhosis (Child-Pugh B,C)
- active infection, uncontrolled inflammatory disease
- progressive malignant disease
- cerebral infarction and intracranial hemorrhage within 6 months,except transient ischemic attack (TIA)
- uncontrolled blood sugar (HbA1c >10%)
- severe anemia, Hb <7g/dL
- Life expectancy less than 12 months at the point of randomization
- Pregnant and willing to bear child during study
- patients, inappropriate to study (researchers decided)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: K-STAR (Kremezin STudy Against Renal Disease Progression in Korea) Randomized, Open-label, Controlled Study
- To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) added to standard-of-care therapy in moderate to severe Chronic Kidney Disease (CKD III-IV), on time to first occurrence of any event of the triple composite outcome of initiation of renal replacement therapy, decline of eGFR 50% or more or doubling of serum creatinine (sCr) when compared with standard-of-care group;
- To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) to GFR and proteinuria;
- To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) to health related quality of life;
- To evaluate the safety and tolerability of long-term AST-120 therapy in patients with CKD;
- To evaluate the all-cause mortality and hospitalization apart from those planned for operation and intervention)
- Conditions
- Chronic Kidney Disease
- Being tested
- AST-120
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AST-120Drug
6g/day (3 times a day)
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Standard-of-care (conservative treatment) |
| 2 | Experimental | AST-120 6g/day (3 times a day) Receives: Drug: AST-120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The development of a component of a triple composite endpoint (doubling of serum Cr, decline of estimated GFR 50% or more by C-G equation, initiation of renal replacement therapy)
Measured: approximately 49 months (at least 12 months for enrollment and 36 months for intervention, 1month for follow up)
Secondary outcomes (1)
change of estimated GFR and urine protein excretion, Assessment of health related quality of life, all-cause mortality
Measured: approximately 49 months (at least 12 months for enrollment and 36 months for intervention, 1month for follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 578 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- HK inno.N Corporation, Kureha Corporation
- Investigators
- Yon Su Kim, M.D.PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860431
- Sponsor's protocol ID
- 06-2008-355-0
- Acronym
- K-STAR
- Status last verified
- Mar 2014
- First submitted
- 9 Mar 2009
- Last updated
- 19 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Baek SH, Cha RH, Kang SW, Park CW, Cha DR, Kim SG, Yoon SA, Kim S, Han SY, Park JH, Chang JH, Lim CS, Kim YS, Na KY. Circulating renalase predicts all-cause mortality and renal outcomes in patients with advanced chronic kidney disease. Korean J Intern Med. 2019 Jul;34(4):858-866. doi: 10.3904/kjim.2017.058. Epub 2017 Nov 29.
PubMed 29172403Lee SW, Kim S, Na KY, Cha RH, Kang SW, Park CW, Cha DR, Kim SG, Yoon SA, Han SY, Park JH, Chang JH, Lim CS, Kim YS. Serum Anion Gap Predicts All-Cause Mortality in Patients with Advanced Chronic Kidney Disease: A Retrospective Analysis of a Randomized Controlled Study. PLoS One. 2016 Jun 1;11(6):e0156381. doi: 10.1371/journal.pone.0156381. eCollection 2016.
PubMed 27249416
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- K-STAR (Kremezin STudy Against Renal Disease Progression in Korea) Randomized, Open-label, Controlled Study
- ClinicalTrials.gov ID
- NCT00860431
- Acronym / sponsor ID
- K-STAR / 06-2008-355-0
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 578 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- HK inno.N Corporation, Kureha Corporation
- Study start
- Mar 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 12 Mar 2009 (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.
- To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) added to standard-of-care therapy in moderate to severe Chronic Kidney Disease (CKD III-IV), on time to first occurrence of any event of the triple composite outcome of initiation of renal replacement therapy, decline of eGFR 50% or more or doubling of serum creatinine (sCr) when compared with standard-of-care group;
- To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) to GFR and proteinuria;
- To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) to health related quality of life;
- To evaluate the safety and tolerability of long-term AST-120 therapy in patients with CKD;
- To evaluate the all-cause mortality and hospitalization apart from those planned for operation and intervention)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Standard-of-care (conservative treatment) |
| 2 | Experimental | Drug: AST-120AST-120 6g/day (3 times a day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Informed consent
- Age 18 years or older
- CKD stage 3,4 (estimated GFR by Cockcroft-Gault equation 15-59 mL/min/1.73m^2)
- Followed up by responsible nephrologists more than 6 months
- eGFR checked 2 times or more during screening period
Key exclusion criteria (17 listed)
- Patients who took medicine AST-120 or ketosteril within 2 months
- Received any investigational agent or participated in a clinical study within the previous 2 months
- History of gastrointestinal disease (active gastric ulcer, inflammatory bowel disease, hiatal hernia, or severe GI dysmotility)
- obstructive urologic disease and other reversible kidney diseases
- chronic kidney disease due to autosomal dominant polycystic kidney disease, ADPKD
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 |
|---|---|---|
| AST-1206g/day (3 times a day) | Drug | 2 |
Primary outcome
The development of a component of a triple composite endpoint (doubling of serum Cr, decline of estimated GFR 50% or more by C-G equation, initiation of renal replacement therapy)
Time frame: approximately 49 months (at least 12 months for enrollment and 36 months for intervention, 1month for follow up)
1 secondary outcome
change of estimated GFR and urine protein excretion, Assessment of health related quality of life, all-cause mortality
Time frame: approximately 49 months (at least 12 months for enrollment and 36 months for intervention, 1month for follow up)
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 19 Mar 2014.
- Derived from this study: PubMed 29172403Baek SH, Cha RH, Kang SW, Park CW, Cha DR, Kim SG, Yoon SA, Kim S, Han SY, Park JH, Chang JH, Lim CS, Kim YS, Na KY. Circulating renalase predicts all-cause mortality and renal outcomes in patients with advanced chronic kidney disease. Korean J Intern Med. 2019 Jul;34(4):858-866. doi: 10.3904/kjim.2017.058. Epub 2017 Nov 29.
- Derived from this study: PubMed 27249416Lee SW, Kim S, Na KY, Cha RH, Kang SW, Park CW, Cha DR, Kim SG, Yoon SA, Han SY, Park JH, Chang JH, Lim CS, Kim YS. Serum Anion Gap Predicts All-Cause Mortality in Patients with Advanced Chronic Kidney Disease: A Retrospective Analysis of a Randomized Controlled Study. PLoS One. 2016 Jun 1;11(6):e0156381. doi: 10.1371/journal.pone.0156381. eCollection 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.
Yon Su Kim, M.D.PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AST-120 in people with Chronic Kidney Disease, run by Seoul National University Hospital at 1 site in South Korea.
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 9 inclusion and 17 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 19 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The development of a component of a triple composite endpoint (doubling of serum Cr, decline of estimated GFR 50% or more by C-G equation, initiation of renal replacement therapy) (time frame: approximately 49 months (at least 12 months for enrollment and 36 months for intervention, 1month for follow up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00860431, which also lists 2 linked publications.
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 19 Mar 2014.