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

Diabetic Nephropathy Clinical Trial

Official title:

Effect of Sarpogrelate On the Nephropathy in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01869881
• Other study ID #: YCM009
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2013
• Est. completion date: January 28, 2015

Study information

• Verified date: April 2019
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: January 28, 2015
• Est. primary completion date: November 17, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Korea University, Anam	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACR(Urine Albumin/Creatinine ratio)	change of percentage	treatment period(24 weeks)
Secondary	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)	Treatment period(24 weeks)
Secondary	urinary 5-HIAA(5-Hydroxyindoleacetic acid), type 4 collagen	changes comparing to baseline data	treatment period(24 weeks)
Secondary	ACR(Urine Albumin/Creatinine ratio)	improved amount comparing to baseline data	treatment period(24 weeks)
Secondary	ACR(Urine Albumin/Creatinine ratio)	rate of normalized ACR	treatment period(24 weeks)
Secondary	Creatinine	improved amount of Creatinine	treatment period(24 weeks)
Secondary	PCR(Protein to Creatinine ratio in Urine)	improved rate comparing to baseline data	treatment period(24 weeks)