Effect of Darbepoetin in Contrast-induced Nephropathy

Phase 2

Terminated

• Conditions: Acute Kidney Injury
• Interventions: Drug: isotonic saline; Drug: darbepoetin-α

• Registration Number: NCT01197235
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2010-09-08
• Study First Submitted QC: 2010-09-08
• Study First Posted: 2010-09-09
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-20
• Last Update Posted: 2014-11-21
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
isotonic saline	isotonic saline	Infusion of isotonic saline will be performed 1 hour before angiography
darbepoetin-α	darbepoetin-α	Infusion of darbepoetin-α 1.5 μg/kg will be performed 1 hour before angiography

Primary Outcome Measures

Name	Time	Method
incidence of contrast-induced nephropathy (CIN)	48 hours	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

Secondary Outcome Measures

Name	Time	Method
maximum difference in Cr levels before and after CAG(coronary angiography) or PCI(percutaneous coronary intervention)	1 month after the 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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital,; 🇰🇷 Seongnam, Korea, Republic of