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CompletedNCT01869881Updated Apr 23, 2021

Effect of Sarpogrelate On the Nephropathy in Type 2 Diabetes (SONATA Study)

A Phase 4 interventional study of Anplag(Sarpogrelate) and Placebo in Diabetic Nephropathy, sponsored by Yuhan Corporation. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-04-23.

Sponsored by Yuhan Corporation · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Feb 2013, registered May 2013).
Phase
Phase 4
Study type
Interventional
Enrollment
151
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

Phase 4 Study to evaluate the safety and effect on decreasing subjects' albuminuria who have Type 2 Diabetes by using sarpogrelate and placebo.

02

Conditions studied

  • Diabetic Nephropathy
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 151 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Yuhan Corporation is the lead sponsor of 107 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
151 participants (actual)

Study arms

  • Active comparator
    Sarpogrelate

    Drug: Anplag(Sarpogrelate)

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugAnplag(Sarpogrelate)

    Sarpogrelate 100mg 2 tablets, bid, 400mg/day

  • DrugPlacebo

    Placebo 100mg 2 tablets, bid, 400mg/day

06

What researchers measure

Primary outcomes

  1. ACR(Urine Albumin/Creatinine ratio)

    change of percentage

    Time frame: treatment period(24 weeks)

Secondary outcomes

  1. 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)

    Time frame: Treatment period(24 weeks)

  2. urinary 5-HIAA(5-Hydroxyindoleacetic acid), type 4 collagen

    changes comparing to baseline data

    Time frame: treatment period(24 weeks)

  3. ACR(Urine Albumin/Creatinine ratio)

    improved amount comparing to baseline data

    Time frame: treatment period(24 weeks)

  4. ACR(Urine Albumin/Creatinine ratio)

    rate of normalized ACR

    Time frame: treatment period(24 weeks)

  5. Creatinine

    improved amount of Creatinine

    Time frame: treatment period(24 weeks)

  6. PCR(Protein to Creatinine ratio in Urine)

    improved rate comparing to baseline data

    Time frame: treatment period(24 weeks)

07

Study locations

1 site
  • Korea University, Anam
    Seoul, Korea, Republic of
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01869881
Lead sponsor
Yuhan Corporation
Responsible party
Sponsor
First posted
Jun 5, 2013
Start date
Feb 1, 2013
Primary completion
Nov 17, 2014
Completion
Jan 28, 2015
Last update
Apr 23, 2021

Study contacts

D.S Choi, MD, PhD
principal investigator · Korea University Hospital, Anam

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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