Deferiprone for the Prevention of Contrast-Induced Acute Kidney Injury

NCT01146925 | Completed Phase 2

• 1 other identifier: CRMD-001-2001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Contrast-Induced Acute Kidney Injury

Keywords

Acute Kidney Injury; Contrast-Induced Nephropathy; Labile Iron; Iron Chelation; Deferiprone

Outcome Measures

Primary Outcomes (1)

• Biomarker evidence of Acute Kidney injury

  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

  8 Days

Secondary Outcomes (1)

• Incidence of Acute Kidney Injury

  48 hours

Study Arms (2)

CRMD-001-Deferiprone

EXPERIMENTAL

Drug: CRMD-001-Deferiprone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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

CRMD-001-Deferiprone

Placebo DRUG

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

Placebo

Eligibility Criteria

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

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• CorMedix: lead

Study Sites (8)

The Care Group, St. Vincent's Hospital

Indianapolis, Indiana, 46290, United States

Location

St. John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Cardiac and Vascular Research Center of Northern Michigan

Petoskey, Michigan, 49770, United States

Location

Providence Hospital

Southfield, Michigan, 48075, United States

Location

Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

Cardiovascular Catheterization Labs at Fairfield

Fairfield, Ohio, 45104, United States

Location

St. Vincent Mercy Medical Center

Toledo, Ohio, 43608, United States

Location

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, 73120, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Peter A. McCullough, MD, MPH

  St. John Providence Health System, Novi, MI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 16, 2010
• First Posted: June 22, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 27, 2011

Record last verified: 2011-06

Locations

US (8)