Effect of Darbepoetin in Contrast-induced Nephropathy

November 20, 2014 updated by: Ki Young Na, Seoul National University Bundang Hospital

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seongnam, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: darbepoetin-α
Infusion of darbepoetin-α 1.5 μg/kg will be performed 1 hour before angiography
Drug: darbepoetin-α
Infusion of darbepoetin-α 1.5 μg/kg will be performed 1 hour before angiography
Other Names:
  • aranesp
Placebo Comparator: isotonic saline
Infusion of isotonic saline will be performed 1 hour before angiography
Drug: isotonic saline
Infusion of isotonic saline will be performed 1 hour before angiography
Other Names:
  • 0.9% NaCl solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of contrast-induced nephropathy (CIN)
Time Frame: 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
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)
Time Frame: 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
1 month after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

SMG-SNU Boramae Medical Center

Investigators

  • Principal Investigator: Ki Young Na, MD PhD, Seoul Ntional University Bundang Hospital, Seoul National University College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

September 8, 2010

First Submitted That Met QC Criteria

September 8, 2010

First Posted (Estimate)

September 9, 2010

Study Record Updates

Last Update Posted (Estimate)

November 21, 2014

Last Update Submitted That Met QC Criteria

November 20, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBH B- 0811/063-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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