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The Prevention of Contrast Induced Nephropathy by Sarpogrelate in Patients With Chronic Kidney Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Seoul National University Boramae Hospital.
Recruitment status was:  Active, not recruiting
Information provided by:
Seoul National University Boramae Hospital Identifier:
First received: July 19, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted


Contrast-induced nephropathy (CIN) is a serious clinical problem associated with increased morbidity and mortality, particularly in patients with chronic renal insufficiency. Although some agents including hydration with saline are being prescribed to prevent renal deterioration in these high risk patients, their efficacy is not clear defined and debatable. Therefore additional prophylactic pretreatments are needed.


Present study aims to investigate differences in occurrence of CIN after sarpogrelate premedication in patients with chronic kidney disease (CKD). 268 participants, aged 20-85 years with a clinical diagnosis of CKD will be recruited. They will be randomly allocated to one of two conditions: (i) a routine treatment without sarpogrelate group (ii) routine treatment with sarpogrelate (a fixed-flexible dose of 300 mg/day). The primary outcome is the occurrence of CIN during 4 weeks after receiving contrast agent.


As of May 2010, there were no registered trials evaluating the therapeutic potentials of sarpogrelate in preventing for CIN. If sarpogrelate decreases the worsening of renal function and occurrence of CIN, it will provide a safe, easy and inexpensive treatment option.

Condition Intervention Phase
Chronic Kidney Disease Drug: sarpogrelate Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase 4 Study of Sarpogrelate That Prevent Contrast-induced Nephropathy

Resource links provided by NLM:

Further study details as provided by Seoul National University Boramae Hospital:

Primary Outcome Measures:
  • incidence of contrast-induced nephropathy [ Time Frame: within 48 hours after using a contrast agent ]
    The primary outcome of the study is the incidence of CIN, defined as either a greater than 25 percent increase of serum Cr or an absolute increase in serum Cr of 0.5 mg/dL within 48 hours after using a contrast agent

Secondary Outcome Measures:
  • occurrence of CIN [ Time Frame: at 4 weeks after using a contrast agent ]
    Clinical endpoint measurements are conducted in-hospital and at 4 weeks. Cr concentration is measured at admission, every day for the next two days after contrast exposure, and at 4 weeks

Estimated Enrollment: 212
Study Start Date: December 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sarpogrelate 300 mg per day
Patients in the sarpogrelate group receive sarpogrelate 300 mg per day for 24 hours before exposure to contrast agent.
Drug: sarpogrelate
sarpogrelate, 300mg/day,duration: 4 weeks
Other Name: Anplag
No Intervention: No sarpogrelate medication

Detailed Description:

All patients with CKD scheduled for CAG will be eligible, assuming their ability to understand the character and individual consequences of participation as well as giving written informed consent. CKD is defined as estimated glomerular filtration rate (eGFR) <60 mL/min per 1.73 m2 using modification of diet in renal disease (MDRD) formula or serum creatinine (Cr) > 1.5 mg/dL.

The MDRD formula was defined in the following way. Where the Cr concentration is in mg/dL:

eGFR = 186 × serum Cr−1.154 × Age−0.203 × (0.742 if female) Exclusion criteria are age less than 20 years or more than 85 years, liver cirrhosis greater than or equal to Child class B, decreased serum platelet level (< 100,000/uL), patients who received or are schedule to receive percutaneous renal intervention, currently are taking anticoagulation drugs, unable to give informed consent. Patients in shock, maintaining hemodialysis, hemofiltration, peritoneal dialysis will be excluded.


Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patient with chronic kidney disease scheduled for coronary angiogram

Exclusion Criteria:

  • age less than 20 years or more than 85 years
  • liver cirrhosis greater than or equal to Child class B
  • decreased serum platelet level (< 100,000/uL)
  • patients who received or are schedule to receive percutaneous renal intervention
  • currently are taking anticoagulation drugs
  • unable to give informed consent
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Please refer to this study by its identifier: NCT01165567

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 156-707
Sponsors and Collaborators
Seoul National University Boramae Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Seoul National University Boramae Hospital, Boramae Medical Center Identifier: NCT01165567     History of Changes
Other Study ID Numbers: 20091104/06-2009-123/89
Study First Received: July 19, 2010
Last Updated: July 19, 2010

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs processed this record on August 18, 2017