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Effect of Darbepoetin in Contrast-induced Nephropathy

Primary Purpose

Acute Kidney Injury

Status
Terminated
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
darbepoetin-α
isotonic saline
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury focused on measuring darbepoetin, chronic kidney disease, coronary angiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Bundang Hospital,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

darbepoetin-α

isotonic saline

Arm Description

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

Infusion of isotonic saline will be performed 1 hour before angiography

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 8, 2010
Last Updated
November 20, 2014
Sponsor
Seoul National University Bundang Hospital
Collaborators
SMG-SNU Boramae Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01197235
Brief Title
Effect of Darbepoetin in Contrast-induced Nephropathy
Official Title
Prevention of Contrast-Induced Nephropathy by Darbepoetin in Patients With Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
difficult to enroll targeted participants
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
SMG-SNU Boramae Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
darbepoetin, chronic kidney disease, coronary angiography

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
darbepoetin-α
Arm Type
Experimental
Arm Description
Infusion of darbepoetin-α 1.5 μg/kg will be performed 1 hour before angiography
Arm Title
isotonic saline
Arm Type
Placebo Comparator
Arm Description
Infusion of isotonic saline will be performed 1 hour before angiography
Intervention Type
Drug
Intervention Name(s)
darbepoetin-α
Other Intervention Name(s)
aranesp
Intervention Description
Infusion of darbepoetin-α 1.5 μg/kg will be performed 1 hour before angiography
Intervention Type
Drug
Intervention Name(s)
isotonic saline
Other Intervention Name(s)
0.9% NaCl solution
Intervention Description
Infusion of isotonic saline will be performed 1 hour before angiography
Primary Outcome Measure Information:
Title
incidence of contrast-induced nephropathy (CIN)
Description
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
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
maximum difference in Cr levels before and after CAG(coronary angiography) or PCI(percutaneous coronary intervention)
Description
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
Time Frame
1 month after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki Young Na, MD PhD
Organizational Affiliation
Seoul Ntional University Bundang Hospital, Seoul National University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital,
City
Seongnam
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

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Effect of Darbepoetin in Contrast-induced Nephropathy

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