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

• ClinicalTrials.gov Identifier: NCT01869881
• Recruitment Status: Completed
• First Posted: June 5, 2013
• Last Update Posted: April 23, 2021
• Sponsor: Yuhan Corporation
• Information provided by (Responsible Party): Yuhan Corporation

Tracking Information

• First Submitted Date: May 31, 2013
• First Posted Date: June 5, 2013
• Last Update Posted Date: April 23, 2021
• Actual Study Start Date: February 1, 2013
• Actual Primary Completion Date: November 17, 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 21, 2021)

ACR(Urine Albumin/Creatinine ratio) [ Time Frame: treatment period(24 weeks) ]

change of percentage

Original Primary Outcome Measures (submitted: June 4, 2013)

• Safety [ Time Frame: treatment period(24 weeks) ]
  adverse event and rate of adverse event
• ACR(Urine Albumin/Creatinine ratio) [ Time Frame: treatment period(24 weeks) ]
  change of percentage

Current Secondary Outcome Measures (submitted: June 4, 2013)

• ACR(Urine Albumin/Creatinine ratio) [ Time Frame: Treatment period(24 weeks) ]
  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)
• urinary 5-HIAA(5-Hydroxyindoleacetic acid), type 4 collagen [ Time Frame: treatment period(24 weeks) ]
  changes comparing to baseline data
• ACR(Urine Albumin/Creatinine ratio) [ Time Frame: treatment period(24 weeks) ]
  improved amount comparing to baseline data
• ACR(Urine Albumin/Creatinine ratio) [ Time Frame: treatment period(24 weeks) ]
  rate of normalized ACR
• Creatinine [ Time Frame: treatment period(24 weeks) ]
  improved amount of Creatinine
• PCR(Protein to Creatinine ratio in Urine) [ Time Frame: treatment period(24 weeks) ]
  improved rate comparing to baseline data

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Sarpogrelate On the Nephropathy in Type 2 Diabetes (SONATA Study)
• Official Title: Effect of Sarpogrelate On the Nephropathy in Type 2 Diabetes
• Brief Summary: Phase 4 Study to evaluate the safety and effect on decreasing subjects' albuminuria who have Type 2 Diabetes by using sarpogrelate and placebo.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Diabetic Nephropathy

Intervention

• Drug: Anplag(Sarpogrelate)
  Sarpogrelate 100mg 2 tablets, bid, 400mg/day
• Drug: Placebo
  Placebo 100mg 2 tablets, bid, 400mg/day

Study Arms

• Active Comparator: Sarpogrelate
  Intervention: Drug: Anplag(Sarpogrelate)
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 21, 2021): 151
• Original Estimated Enrollment (submitted: June 4, 2013): 166
• Actual Study Completion Date: January 28, 2015
• Actual Primary Completion Date: November 17, 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT01869881
• Other Study ID Numbers: YCM009
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Yuhan Corporation
• Original Responsible Party: Same as current
• Current Study Sponsor: Yuhan Corporation
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: D.S Choi, MD, PhD; Korea University Hospital, Anam

• PRS Account: Yuhan Corporation
• Verification Date: April 2019