Fenoldopam for Prevention of Acute Kidney Injury (FANCY)

• ClinicalTrials.gov Identifier: NCT01690832
• Recruitment Status: Unknown
• First Posted: September 24, 2012
• Last Update Posted: September 24, 2012
• Sponsor: University of Roma La Sapienza
• Information provided by (Responsible Party): Francesco Pelliccia, University of Roma La Sapienza

Tracking Information

• First Submitted Date: September 19, 2012
• First Posted Date: September 24, 2012
• Last Update Posted Date: September 24, 2012
• Study Start Date: September 2012
• Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 19, 2012)

Contrast induced acute kidney injury [ Time Frame: 48 hour ]

Incidence of contrast induced acute kidney injury at 48 hour post-procedural control

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 19, 2012)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Fenoldopam for Prevention of Acute Kidney Injury
• 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

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.

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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Coronary Artery Disease

Intervention

• 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)

Study Arms

• 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.
  Intervention: Drug: standard 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.
  Interventions:

  • Drug: standard saline infusion
  • Drug: fenoldopam infusion

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: September 19, 2012): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2014
• Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT01690832
• Other Study ID Numbers: 595/2012/D
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Francesco Pelliccia, University of Roma La Sapienza
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Roma La Sapienza
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Francesco Pelliccia, MD; Sapienza University

• PRS Account: University of Roma La Sapienza
• Verification Date: September 2012