Chronic Kidney Disease Clinical Trial
Official title:
Phase 4 Study of Sarpogrelate That Prevent Contrast-induced Nephropathy
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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