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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRMD-001-Deferiprone | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Age 18 or older
eGFR of < 60 ml/min/1.73 m2
Presence of at least one additional risk factor:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter A. McCullough, MD, MPH | St. John Providence Health System, Novi, MI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Care Group, St. Vincent's Hospital | Indianapolis | Indiana | 46290 | United States | ||
| St. John Hospital and Medical Center |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Placebo | Drug | 3 placebo tablets will be given every 12 hours for a total of 8 days, beginning 1-3 hours prior to angiography |
|
| Detroit |
| Michigan |
| 48236 |
| United States |
| Cardiac and Vascular Research Center of Northern Michigan | Petoskey | Michigan | 49770 | United States |
| Providence Hospital | Southfield | Michigan | 48075 | United States |
| Ohio Health Research Institute | Columbus | Ohio | 43214 | United States |
| Cardiovascular Catheterization Labs at Fairfield | Fairfield | Ohio | 45104 | United States |
| St. Vincent Mercy Medical Center | Toledo | Ohio | 43608 | United States |
| Oklahoma Cardiovascular Research Group | Oklahoma City | Oklahoma | 73120 | United States |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |