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

Study Overview
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Brief Summary
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Background: 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. Methods/Design: 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. Discussion: 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.

Detailed Description
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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.

Official Title
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Phase 4 Study of Sarpogrelate That Prevent Contrast-induced Nephropathy

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Drug: sarpogrelate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sarpogrelate 300 mg per day<br>Patients in the sarpogrelate group receive sarpogrelate 300 mg per day for 24 hours before exposure to contrast agent. | Drug: sarpogrelate<br>* sarpogrelate, 300mg/day,duration: 4 weeks<br>* Other names: Anplag;|
| No Intervention: No sarpogrelate medication<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of contrast-induced nephropathy | 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 | within 48 hours after using a contrast agent | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of CIN | 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 | at 4 weeks after using a contrast agent |