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Effect of Darbepoetin in Contrast-induced Nephropathy

NCT ID: NCT01197235

Last Updated: 2014-11-21

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

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2015-12-31

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.

Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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darbepoetin-α

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

Group Type EXPERIMENTAL

darbepoetin-α

Intervention Type DRUG

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

isotonic saline

Infusion of isotonic saline will be performed 1 hour before angiography

Group Type PLACEBO_COMPARATOR

isotonic saline

Intervention Type DRUG

Infusion of isotonic saline will be performed 1 hour before angiography

Interventions

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darbepoetin-α

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

Intervention Type DRUG

isotonic saline

Infusion of isotonic saline will be performed 1 hour before angiography

Intervention Type DRUG

Other Intervention Names

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aranesp 0.9% NaCl solution

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SMG-SNU Boramae Medical Center

OTHER

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ki Young Na

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ki Young Na, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul Ntional University Bundang Hospital, Seoul National University College of Medicine

Locations

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Seoul National University Bundang Hospital,

Seongnam, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SNUBH B- 0811/063-001

Identifier Type: -

Identifier Source: org_study_id