Effect of Darbepoetin in Contrast-induced Nephropathy

NCT01197235 | Terminated Phase 2

• 1 other identifier: SNUBH B- 0811/063-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

darbepoetin, chronic kidney disease, coronary angiography

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• maximum difference in Cr levels before and after CAG(coronary angiography) or PCI(percutaneous coronary intervention)

  1 month after the intervention

Study Arms (2)

darbepoetin-α

EXPERIMENTAL

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

Drug: darbepoetin-α

isotonic saline

PLACEBO COMPARATOR

Infusion of isotonic saline will be performed 1 hour before angiography

Drug: isotonic saline

Interventions

darbepoetin-α DRUG

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

Also known as: aranesp

darbepoetin-α

isotonic saline DRUG

Infusion of isotonic saline will be performed 1 hour before angiography

Also known as: 0.9% NaCl solution

isotonic saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age over 18 yr
• estimated glomerular filtration rate (GFR) \< 60 ml/min/1.73m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• SMG-SNU Boramae Medical Center: collaborator

Study Sites (1)

Seoul National University Bundang Hospital,

Seongnam, 463-707, South Korea

Location

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency, Chronic

Interventions

Darbepoetin alfa; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ki Young Na, MD PhD

  Seoul Ntional University Bundang Hospital, Seoul National University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 8, 2010
• First Posted: September 9, 2010
• Study Start: May 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 21, 2014

Record last verified: 2014-11

Locations

KR (1)