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Fenoldopam for Prevention of Acute Kidney Injury (FANCY)

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ClinicalTrials.gov Identifier: NCT01690832
Recruitment Status : Unknown
Verified September 2012 by Francesco Pelliccia, University of Roma La Sapienza.
Recruitment status was:  Active, not recruiting
First Posted : September 24, 2012
Last Update Posted : September 24, 2012
Sponsor:
Information provided by (Responsible Party):
Francesco Pelliccia, University of Roma La Sapienza

Study Description
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Brief Summary:

Patients with acute coronary syndromes (ACS) are at increased risk for acute kidney injury (AKI) when they undergo urgent/emergency coronary angiography.

The optimal medical treatment for preventing the occurrence of contrast induced - acute kidney injury is still controversial.

Fenoldopam mesylate is a dopamine A1 receptor agonist that augments renal plasma flow that has reduced the risk of radiocontrast dye nephropathy in some (but not all) preliminary studies.

Neutrophil gelatinase-associated lipocalin (NGAL) is a new biomarker predictive for AKI already shown to be useful for earlier diagnosis of contrast induced nephropathy.

The primary objective of this study is to to test the hypothesis that fenoldopam, in addition to standard treatment, reduce the occurrence of contrast induced - acute kidney injury in patients with acute coronary syndrome (ACS) undergoing urgent/emergency coronary angiography and/or percutaneous coronary intervention.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: standard saline infusion Drug: fenoldopam infusion Phase 4

Detailed Description:

Patients with acute coronary syndromes (ACS) are at increased risk for acute kidney injury (AKI) when they undergo urgent/emergency coronary angiography.

The optimal medical treatment for preventing the occurrence of contrast induced - acute kidney injury is still controversial.

Fenoldopam mesylate is a dopamine A1 receptor agonist that augments renal plasma flow that has reduced the risk of radiocontrast dye nephropathy in some (but not all) preliminary studies.

Neutrophil gelatinase-associated lipocalin (NGAL) is a new biomarker predictive for AKI already shown to be useful for earlier diagnosis of contrast induced nephropathy.

The primary objective of this study is to to test the hypothesis that fenoldopam, in addition to standard treatment, reduce the occurrence of contrast induced - acute kidney injury in patients with acute coronary syndrome (ACS) undergoing urgent/emergency coronary angiography and/or percutaneous coronary intervention.

Patients will be randomized to standard i.v. 1 ml/kg/h saline infusion (Gr. A, N= 50) or to a combination of i.v. 1 ml/kg/h saline infusion and fenoldopam administration (0.08 mcg/Kg/min) from 6 hours before the procedure to 12 hours after the procedure.

Primary End-points

• Incidence of contrast induced acute kidney injury

Secondary End-points

• Post-angiographic 48-h absolute increase in creatinine, absolute increase in estimated glomerular filtration rate, and Neutrophil gelatinase-associated lipocalin (NGAL) value

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Fenoldopam for Prevention of Acute kidNey Injury in Patients With aCute coronarY Syndrome Undergoing Coronary Angiography and/or Percutaneous Coronary Intervention - The FANCY Trial
Study Start Date : September 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: standard saline infusion
standard i.v. 1 ml/kg/h saline infusion from 6 hours before the procedure to 12 hours after the procedure.
 Drug: standard saline infusion
i.v. 1 ml/kg/h saline infusion from 6 hours before the procedure to 12 hours after the procedure
Other Name: saline infusion
Active Comparator: fenoldopam infusion
combination of i.v. 1 ml/kg/h saline infusion and fenoldopam administration (0.08 mcg/Kg/min) from 6 hours before the procedure to 12 hours after the procedure.
 Drug: standard saline infusion
i.v. 1 ml/kg/h saline infusion from 6 hours before the procedure to 12 hours after the procedure
Other Name: saline infusion

Drug: fenoldopam infusion
combination of i.v. 1 ml/kg/h saline infusion and fenoldopam administration (0.08 mcg/Kg/min) from 6 hours before the procedure to 12 hours after the procedure
Other Name: fenoldopam administration (0.08 mcg/Kg/min)


Outcome Measures
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Primary Outcome Measures :
  1. Contrast induced acute kidney injury [ Time Frame: 48 hour ]
    Incidence of contrast induced acute kidney injury at 48 hour post-procedural control


Secondary Outcome Measures :
  1. Markers of kidney injury [ Time Frame: 48 hour ]
    Post-angiographic 48-h absolute increase in creatinine, absolute increase in estimated glomerular filtration rate, and Neutrophil gelatinase-associated lipocalin (NGAL) value


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Indication to urgent/emergency coronary angiography
  • Normal renal function (eGFR> 60 ml/min/1.73 m2)
  • Moderate or high Mehran's risk score for CIN (>11).
  • Able to understand and willing to sign the informed CF

Exclusion Criteria:

• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01690832


Locations
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Italy
Sapienza University
Rome, Lazio, Italy, 00166
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
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Principal Investigator: Francesco Pelliccia, MD Sapienza University
More Information
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Responsible Party: Francesco Pelliccia, Assistant Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01690832    
Other Study ID Numbers: 595/2012/D
First Posted: September 24, 2012    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012
Keywords provided by Francesco Pelliccia, University of Roma La Sapienza:
Contrast induced acute kidney injury
Additional relevant MeSH terms:
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Acute Kidney Injury
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
 Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Fenoldopam
Antihypertensive Agents
Vasodilator Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs