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Completed

NCT Number: NCT01146925

Deferiprone for the Prevention of Contrast-Induced Acute Kidney Injury

The primary objective of this trial is to assess the impact of CRMD-001 on markers of contrast-induced acute kidney injury (AKI) in high-risk patients with chronic kidney disease (CKD) undergoing coronary angiography and PCI.

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Key information

Conditions

Contrast-Induced Acute Kidney Injury Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Care Group, St. Vincent's Hospital, Indianapolis, Indiana, United States

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About this study

This trial will evaluate whether treatment with CRMD-001 (unique formulations of the iron chelator, Deferiprone) will reduce the incidence of AKI in subjects with CKD and additional risk factors. Adult subjects with moderate to severe CKD who are undergoing coronary angiography and PCI will be randomized to either placebo or CRMD-001 and followed for 90 days. Subjects will receive 8 days of randomized therapy starting 1-3 hours prior to angiography. The primary endpoint of the trial will be the difference in mean paired change of a panel of sensitive renal biomarkers between the groups. Differences in renal or cardiovascular clinical events will also be evaluated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or older
  • eGFR of < 60 ml/min/1.73 m2
  • Presence of at least one additional risk factor:
  • Diabetes Mellitus
  • Age ≥ 75 years
  • Left Ventricular Ejection Fraction ≤ 40%

Exclusion criteria

  • End-Stage Renal Disease
  • Recent change in serum creatinine
  • Primary PCI for STEMI
  • Currently receiving mechanical ventilation
  • Severe heart failure of cardiogenic shock
  • Requirement for inotropic support (prior 30 days)
  • Sustained hypertension > or = 200/110
  • Subject not expected to live for 90 days
  • Anticipated use of ioxaglate or iohexol
  • Currently receiving fenoldopam, dopamine, theophylline, aminophylline, mannitol, N-acetyl cysteine or Ascorbic acid
  • Absolute neutrophil count < 1500
  • Hemoglobin < 8 gm/dL

Treatment and study plan

CRMD-001-Deferiprone

Drug

CRMD-001 represents unique formulations of Deferiprone. Subjects will be given one (900 mg) immediate release and two (900 mg) extended release tablets 1-3 hours prior to angiography and then every 12 hours for a total of 8 days

Placebo

Drug

3 placebo tablets will be given every 12 hours for a total of 8 days, beginning 1-3 hours prior to angiography

Primary outcomes

  1. Biomarker evidence of Acute Kidney injury

    Time frame: 8 Days

    Mean paired change in a panel of acute kidney injury (AKI) biomarkers (urinary NGAL, LFABP, interleukin-18 (IL-18), kidney injury molecule-1 (KIM-1), urinary alpha GST (proximal tubular injury), Pi GST (distal tubular injury) and cystatin C; serum cystatin C) from baseline (Day 1) to peak in the deferiprone and placebo treatment groups, within 192 hours of contrast exposure

Secondary outcomes

  1. Incidence of Acute Kidney Injury

    Time frame: 48 hours

    Incidence of AKI defined as an absolute increase in serum Cr of ≥ 0.3 mg/dL, and/or a 50% relative increase in serum Cr from baseline (Day 1) to a maximum value obtained within 48 hours of contrast exposure

Sponsors and collaborators

Lead sponsor

CorMedix

Industry

Registry information

Official study title

A Phase II, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy and Safety of CRMD-001 in Contrast-Induced Acute Oxidative Kidney Injury

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 22, 2010
Registry last updated
Jun 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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