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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation
ClinicalTrials.gov Identifier:
NCT01869881
First received: May 31, 2013
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Diabetic Nephropathy
Drug: Anplag(Sarpogrelate)
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Sarpogrelate On the Nephropathy in Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Yuhan Corporation:

Primary Outcome Measures:
  • Safety [ Time Frame: treatment period(24 weeks) ] [ Designated as safety issue: Yes ]
    adverse event and rate of adverse event

  • ACR(Urine Albumin/Creatinine ratio) [ Time Frame: treatment period(24 weeks) ] [ Designated as safety issue: No ]
    change of percentage


Secondary Outcome Measures:
  • ACR(Urine Albumin/Creatinine ratio) [ Time Frame: Treatment period(24 weeks) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    changes comparing to baseline data

  • ACR(Urine Albumin/Creatinine ratio) [ Time Frame: treatment period(24 weeks) ] [ Designated as safety issue: No ]
    improved amount comparing to baseline data

  • ACR(Urine Albumin/Creatinine ratio) [ Time Frame: treatment period(24 weeks) ] [ Designated as safety issue: No ]
    rate of normalized ACR

  • Creatinine [ Time Frame: treatment period(24 weeks) ] [ Designated as safety issue: No ]
    improved amount of Creatinine

  • PCR(Protein to Creatinine ratio in Urine) [ Time Frame: treatment period(24 weeks) ] [ Designated as safety issue: No ]
    improved rate comparing to baseline data


Estimated Enrollment: 166
Study Start Date: February 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sarpogrelate Drug: Anplag(Sarpogrelate)
Sarpogrelate 100mg 2 tablets, bid, 400mg/day
Placebo Comparator: Placebo Drug: Placebo
Placebo 100mg 2 tablets, bid, 400mg/day

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01869881

Locations
Korea, Republic of
Korea University, Anam
Seoul, Korea, Republic of
Sponsors and Collaborators
Yuhan Corporation
Investigators
Principal Investigator: D.S Choi, MD, PhD Korea University Hospital, Anam
  More Information

No publications provided

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01869881     History of Changes
Other Study ID Numbers: YCM009
Study First Received: May 31, 2013
Last Updated: July 8, 2014
Health Authority: Korea: Ministry of Food and Drug Safety

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Kidney Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Urologic Diseases
Sarpogrelate
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014