Diabetic NephropathyPhase 4NCT01869881
Effect of Sarpogrelate On the Nephropathy in Type 2 Diabetes (SONATA Study)
A Phase 4 study testing Anplag(Sarpogrelate) in people with Diabetic Nephropathy, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
Phase 4 Study to evaluate the safety and effect on decreasing subjects' albuminuria who have Type 2 Diabetes by using sarpogrelate and placebo. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- Anplag(Sarpogrelate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2013to 28 Jan 2015
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- person who signed on ICF
- Type 2 diabetic patient who have microalbuminuria or overt proteinuria
- In case of hypertension patients, who keep the same medication steadily over last 4 weeks
Who cannot join
- patients who have hypersensitivity on sarpogrelate or other salicylic acid
- patients who should keep the antiplatelet agent because of acute cardiac disease or peripheral vein disease
- patients who took other anticoagulant agent within 1 month
- patient who take ACEI OR ARB but not controlled(over 150/100mmHg)
- Type 1 diabetes patients
- Patient who have cardiac or liver problem
- Cr: >1.8mg/dl or GFR: <40ml/min
- malignant tumor patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Sarpogrelate On the Nephropathy in Type 2 Diabetes
Phase 4 Study to evaluate the safety and effect on decreasing subjects' albuminuria who have Type 2 Diabetes by using sarpogrelate and placebo.
- Conditions
- Diabetic Nephropathy
- Being tested
- Anplag(Sarpogrelate), Placebo
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anplag(Sarpogrelate)Drug
Sarpogrelate 100mg 2 tablets, bid, 400mg/day
PlaceboDrug
Placebo 100mg 2 tablets, bid, 400mg/day
| Study group | Role | What they receive |
|---|---|---|
| Sarpogrelate | Active comparator | Not described Receives: Drug: Anplag(Sarpogrelate) |
| 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.
ACR(Urine Albumin/Creatinine ratio)
change of percentage
Measured: treatment period(24 weeks)
Secondary outcomes (6)
ACR(Urine Albumin/Creatinine ratio)
improvement efficiency rate of ACR comparing to baseline Definition of improvement efficiency : ACR become normal(<20mg/g Cr) or ACR is decreased more than 50% comparing to data before taking IP(Investigators' product)
Measured: Treatment period(24 weeks)
urinary 5-HIAA(5-Hydroxyindoleacetic acid), type 4 collagen
changes comparing to baseline data
Measured: treatment period(24 weeks)
ACR(Urine Albumin/Creatinine ratio)
improved amount comparing to baseline data
Measured: treatment period(24 weeks)
ACR(Urine Albumin/Creatinine ratio)
rate of normalized ACR
Measured: treatment period(24 weeks)
Creatinine
improved amount of Creatinine
Measured: treatment period(24 weeks)
PCR(Protein to Creatinine ratio in Urine)
improved rate comparing to baseline data
Measured: treatment period(24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study start1 Feb 2013
- Primary completion17 Nov 2014
- Study completion28 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- D.S Choi, MD, PhD, Principal investigator, Korea University Hospital, Anam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869881
- Sponsor's protocol ID
- YCM009
- Status last verified
- Apr 2019
- First submitted
- 31 May 2013
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
PubMed 35224730
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sarpogrelate On the Nephropathy in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01869881
- Acronym / sponsor ID
- YCM009
- Conditions
- Diabetic Nephropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 17 Nov 2014 (actual)
- Study completion
- 28 Jan 2015 (actual)
- First posted
- 5 Jun 2013 (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.
Phase 4 Study to evaluate the safety and effect on decreasing subjects' albuminuria who have Type 2 Diabetes by using sarpogrelate and placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarpogrelate | Active comparator | Drug: Anplag(Sarpogrelate) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- person who signed on ICF
- Type 2 diabetic patient who have microalbuminuria or overt proteinuria
- In case of hypertension patients, who keep the same medication steadily over last 4 weeks
Key exclusion criteria (8 listed)
- patients who have hypersensitivity on sarpogrelate or other salicylic acid
- patients who should keep the antiplatelet agent because of acute cardiac disease or peripheral vein disease
- patients who took other anticoagulant agent within 1 month
- patient who take ACEI OR ARB but not controlled(over 150/100mmHg)
- Type 1 diabetes patients
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 |
|---|---|---|
| Anplag(Sarpogrelate)Sarpogrelate 100mg 2 tablets, bid, 400mg/day | Drug | Sarpogrelate |
| PlaceboPlacebo 100mg 2 tablets, bid, 400mg/day | Drug | Placebo |
Primary outcome
ACR(Urine Albumin/Creatinine ratio)
Time frame: treatment period(24 weeks)
change of percentage
6 secondary outcomes
ACR(Urine Albumin/Creatinine ratio)
Time frame: Treatment period(24 weeks)
urinary 5-HIAA(5-Hydroxyindoleacetic acid), type 4 collagen
Time frame: treatment period(24 weeks)
ACR(Urine Albumin/Creatinine ratio)
Time frame: treatment period(24 weeks)
ACR(Urine Albumin/Creatinine ratio)
Time frame: treatment period(24 weeks)
Creatinine
Time frame: treatment period(24 weeks)
PCR(Protein to Creatinine ratio in Urine)
Time frame: treatment period(24 weeks)
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 23 Apr 2021.
- Derived from this study: PubMed 35224730Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
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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.
D.S Choi, MD, PhD principal investigator
Korea University Hospital, Anam
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 Anplag(Sarpogrelate) in people with Diabetic Nephropathy, run by Yuhan Corporation 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 3 inclusion and 8 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 23 Apr 2021. 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. 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 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?
ACR(Urine Albumin/Creatinine ratio) (time frame: treatment period(24 weeks)). 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 NCT01869881, which also lists 1 linked publication.
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 23 Apr 2021.