Effect of Darbepoetin in Contrast-induced Nephropathy

Seoul National University

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Acute Kidney Injury

Treatments: Drug: isotonic saline; Drug: darbepoetin-α

Study type: Interventional

Funder types: Other

Identifiers

NCT01197235

SNUBH B- 0811/063-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

darbepoetin-α

Experimental group

Description:

Infusion of darbepoetin-α 1.5 μg/kg will be performed 1 hour before angiography

Treatment:

Drug: darbepoetin-α

isotonic saline

Placebo Comparator group

Description:

Infusion of isotonic saline will be performed 1 hour before angiography

Treatment:

Drug: isotonic saline