Effect of Darbepoetin in Contrast-induced Nephropathy
This study is currently recruiting participants.
Verified November 2012 by Seoul National University Bundang Hospital
Sponsor:
Seoul National University Bundang Hospital
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
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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
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 Urologic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on June 18, 2013