Deferiprone for the Prevention of Contrast-Induced Acute Kidney Injury

Contrast-Induced Acute Kidney Injury Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01146925
• Other study ID #: CRMD-001-2001
• Status: Completed
• Phase: Phase 2
• First received: June 16, 2010
• Last updated: June 23, 2011
• Start date: June 2010
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: CorMedix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 or older

2. eGFR of < 60 ml/min/1.73 m2

3. Presence of at least one additional risk factor:

• Diabetes Mellitus

• Age = 75 years

• Left Ventricular Ejection Fraction = 40%

Exclusion Criteria:

1. End-Stage Renal Disease

2. Recent change in serum creatinine

3. Primary PCI for STEMI

4. Currently receiving mechanical ventilation

5. Severe heart failure of cardiogenic shock

6. Requirement for inotropic support (prior 30 days)

7. Sustained hypertension > or = 200/110

8. Subject not expected to live for 90 days

9. Anticipated use of ioxaglate or iohexol

10. Currently receiving fenoldopam, dopamine, theophylline, aminophylline, mannitol, N-acetyl cysteine or Ascorbic acid

11. Absolute neutrophil count < 1500

12. Hemoglobin < 8 gm/dL

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Contrast-Induced Acute Kidney Injury

Intervention

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

Locations

Country	Name	City	State
United States	Ohio Health Research Institute	Columbus	Ohio
United States	St. John Hospital and Medical Center	Detroit	Michigan
United States	Cardiovascular Catheterization Labs at Fairfield	Fairfield	Ohio
United States	The Care Group, St. Vincent's Hospital	Indianapolis	Indiana
United States	Oklahoma Cardiovascular Research Group	Oklahoma City	Oklahoma
United States	Cardiac and Vascular Research Center of Northern Michigan	Petoskey	Michigan
United States	Providence Hospital	Southfield	Michigan
United States	St. Vincent Mercy Medical Center	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
CorMedix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Incidence of Acute Kidney Injury	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	48 hours	No