NCT01869881

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 5, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2015

Completed
Last Updated

April 23, 2021

Status Verified

April 1, 2019

Enrollment Period

1.8 years

First QC Date

May 31, 2013

Last Update Submit

April 21, 2021

Conditions

Diabetic Nephropathy

Outcome Measures

Primary Outcomes (1)

  • ACR(Urine Albumin/Creatinine ratio)

    change of percentage

    treatment period(24 weeks)

Secondary Outcomes (6)

  • ACR(Urine Albumin/Creatinine ratio)

    Treatment period(24 weeks)

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

    treatment period(24 weeks)

  • ACR(Urine Albumin/Creatinine ratio)

    treatment period(24 weeks)

  • ACR(Urine Albumin/Creatinine ratio)

    treatment period(24 weeks)

  • Creatinine

    treatment period(24 weeks)

  • +1 more secondary outcomes

Study Arms (2)

Sarpogrelate

ACTIVE COMPARATOR
Drug: Anplag(Sarpogrelate)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Anplag(Sarpogrelate)DRUG

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

Sarpogrelate
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University, Anam

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 35224730DERIVED

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • D.S Choi, MD, PhD

    Korea University Hospital, Anam

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2013

First Posted

June 5, 2013

Study Start

February 1, 2013

Primary Completion

November 17, 2014

Study Completion

January 28, 2015

Last Updated

April 23, 2021

Record last verified: 2019-04

Locations

KR(1)