Effect of Darbepoetin in Contrast-induced Nephropathy

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01197235
• Other study ID #: SNUBH B- 0811/063-001
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: September 8, 2010
• Last updated: November 20, 2014
• Start date: May 2009
• Est. completion date: December 2015

Study information

• Verified date: November 2014
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury
• Renal Insufficiency, Chronic

Intervention

Drug:
• darbepoetin-a
Infusion of darbepoetin-a 1.5 µg/kg will be performed 1 hour before angiography
• isotonic saline
Infusion of isotonic saline will be performed 1 hour before angiography

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital,	Seongnam

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	48 hours	No
Secondary	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	1 month after the intervention	No