Effect of Darbepoetin in Contrast-induced Nephropathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Seoul National University Bundang Hospital
Sponsor:
Collaborator:
SMG-SNU Boramae Medical Center
Information provided by (Responsible Party):
Ki Young Na, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01197235
First received: September 8, 2010
Last updated: November 2, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Acute Kidney Injury
Drug: darbepoetin-α
Drug: isotonic saline
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Contrast-Induced Nephropathy by Darbepoetin in Patients With Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • incidence of contrast-induced nephropathy (CIN) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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) [ Time Frame: 1 month after the intervention ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 330
Study Start Date: May 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 0.9% NaCl solution

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01197235

Contacts
Contact: Hyunjin Cho 82-31-787-7030

Locations
Korea, Republic of
Seoul National University Bundang Hospital, Recruiting
Seongnam, Korea, Republic of, 463-707
Contact: Hyunjin Cho         
Principal Investigator: Ki Young Na, MD PhD         
Sponsors and Collaborators
Seoul National University Bundang Hospital
SMG-SNU Boramae Medical Center
Investigators
Principal Investigator: Ki Young Na, MD PhD Seoul Ntional University Bundang Hospital, Seoul National University College of Medicine
  More Information

No publications provided

Responsible Party: Ki Young Na, Associate Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01197235     History of Changes
Other Study ID Numbers: SNUBH B- 0811/063-001
Study First Received: September 8, 2010
Last Updated: November 2, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Bundang Hospital:
darbepoetin, chronic kidney disease, coronary angiography

Additional relevant MeSH terms:
Kidney Diseases
Acute Kidney Injury
Renal Insufficiency, Chronic
Wounds and Injuries
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on July 24, 2014