Effect of Darbepoetin in Contrast-induced Nephropathy

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the drug that produce red blood cells is effective in the prevention of kidney dysfunction after coronary angiography in patients with chronic kidney disease.

Detailed Description
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Use of radiocontrast agent is inevitable in computed tomography or angiography. However, contrast agent can aggravate kidney function. Contrast-induced nephropathy (CIN) refers to the clinical situation where decreased kidney function after use of contrast. CIN is the 3rd most common cause of acute kidney injury in the hospitals. There are a lot of reports that death rate is increased in patients with CIN. Erythropoietin is an agent that treat anemia. It also has been reported to have a tissue-protective effect in the animal experiments. In this study, we hypothesized that erythropoietin can reduce the incidence of CIN in patients with chronic kidney disease undergoing coronary angiography.

Official Title
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Prevention of Contrast-Induced Nephropathy by Darbepoetin in Patients With Chronic Kidney Disease

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Drug: darbepoetin-α
* Drug: isotonic saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age over 18 yr estimated glomerular filtration rate (GFR) < 60 ml/min/1.73m2 Exclusion Criteria: Chronic renal replacement therapy (hemodialysis, peritoneal dialysis, continuous renal replacement therapy) Pregnancy or lactation Use of contrast agent within 1 week Emergent CAG or PCI Not recovered from AKI(acute kidney injury) Use of nephrotoxic drugs within 48 hr Cardiogenic shock (SBP(systolic blood pressure) < 90 mmHg) or pulmonary edema Uncontrolled hypertension (SBP ≥ 200 mmHg or DBP(diastolic blood pressure) ≥ 130 mmHg) History of hypersensitivity to contrast agent Known allergy or hypersensitivity to EPO(erythropoietin) Use of EPO within 1 month Anemia (hemoglobin < 9 g/dL) Ventilatory care

Ages Eligible for Study
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Minimum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: darbepoetin-α<br>Infusion of darbepoetin-α 1.5 μg/kg will be performed 1 hour before angiography | Drug: darbepoetin-α<br>* Infusion of darbepoetin-α 1.5 μg/kg will be performed 1 hour before angiography<br>* Other names: aranesp;|
| Placebo Comparator: isotonic saline<br>Infusion of isotonic saline will be performed 1 hour before angiography | Drug: isotonic saline<br>* Infusion of isotonic saline will be performed 1 hour before angiography<br>* Other names: 0.9% NaCl solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of contrast-induced nephropathy (CIN) | a greater than 25 percent increase in serum Cr or an absolute increase in serum Cr of 0.5 mg/dL within 48 hours after using the contrast agent | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum difference in Cr levels before and after CAG(coronary angiography) or PCI(percutaneous coronary intervention) | the maximum difference in Cr levels before and after CAG or PCI, the incidence of AKI requiring renal replacement therapy, length of hospital stay, mortality, myocardial infarction, revascularization, and the occurrence of stroke | 1 month after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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darbepoetin, chronic kidney disease, coronary angiography