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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-12-31

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.

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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.

Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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sarpogrelate 300 mg per day

Patients in the sarpogrelate group receive sarpogrelate 300 mg per day for 24 hours before exposure to contrast agent.

Group Type EXPERIMENTAL

sarpogrelate

Intervention Type DRUG

sarpogrelate, 300mg/day,duration: 4 weeks

No sarpogrelate medication

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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sarpogrelate

sarpogrelate, 300mg/day,duration: 4 weeks

Intervention Type DRUG

Other Intervention Names

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Anplag

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No