Trial | NCT01146925  Report issue

Title

Deferiprone for the Prevention of Contrast-Induced Acute Kidney Injury
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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    deferiprone ...

  • Study Participants

    60
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.
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.
Study Started
Jun 30
2010
Primary Completion
Jun 30
2011
Study Completion
Jun 30
2011
Last Update
Jun 27
2011
Estimate

Drug CRMD-001-Deferiprone

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

Drug Placebo

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

CRMD-001-Deferiprone Experimental

Placebo Placebo Comparator

Criteria 

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
No Results Posted