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

Primary Purpose

Diabetic Nephropathy

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Anplag(Sarpogrelate)

Placebo

About this trial

This is an interventional treatment trial for Diabetic Nephropathy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Korea University, Anam

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sarpogrelate

Placebo

Arm Description

Outcomes

Primary Outcome Measures

ACR(Urine Albumin/Creatinine ratio)

change of percentage

Secondary Outcome Measures

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)

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

changes comparing to baseline data

ACR(Urine Albumin/Creatinine ratio)

improved amount comparing to baseline data

ACR(Urine Albumin/Creatinine ratio)

rate of normalized ACR

Creatinine

improved amount of Creatinine

PCR(Protein to Creatinine ratio in Urine)

improved rate comparing to baseline data

Full Information

NCT ID

NCT01869881

First Posted

May 31, 2013

Last Updated

April 21, 2021

Sponsor

Yuhan Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01869881

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

February 1, 2013 (Actual)

Primary Completion Date

November 17, 2014 (Actual)

Study Completion Date

January 28, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yuhan Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Nephropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

151 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sarpogrelate

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Anplag(Sarpogrelate)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

ACR(Urine Albumin/Creatinine ratio)

Description

change of percentage

Time Frame

treatment period(24 weeks)

Secondary Outcome Measure Information:

Title

ACR(Urine Albumin/Creatinine ratio)

Description

Time Frame

Treatment period(24 weeks)

Title

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

Description

changes comparing to baseline data

Time Frame

treatment period(24 weeks)

Title

ACR(Urine Albumin/Creatinine ratio)

Description

improved amount comparing to baseline data

Time Frame

treatment period(24 weeks)

Title

ACR(Urine Albumin/Creatinine ratio)

Description

rate of normalized ACR

Time Frame

treatment period(24 weeks)

Title

Creatinine

Description

improved amount of Creatinine

Time Frame

treatment period(24 weeks)

Title

PCR(Protein to Creatinine ratio in Urine)

Description

improved rate comparing to baseline data

Time Frame

treatment period(24 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

D.S Choi, MD, PhD

Organizational Affiliation

Korea University Hospital, Anam

Official's Role

Principal Investigator

Facility Information:

Facility Name

Korea University, Anam

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

35224730

Citation

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.

Results Reference

derived

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

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