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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01165567
Recruitment Status : Unknown
Verified July 2010 by Seoul National University Boramae Hospital.
Recruitment status was:  Active, not recruiting
First Posted : July 20, 2010
Last Update Posted : July 20, 2010
Information provided by:
Seoul National University Boramae Hospital

Brief Summary:


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 or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: sarpogrelate Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 participants
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
Study Start Date : December 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01165567

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

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
First Posted: July 20, 2010    Key Record Dates
Last Update Posted: July 20, 2010
Last Verified: July 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