Recent Updates
Recently added Catalysts

CRMD-001-Deferiprone

Phase 2

Contrast-Induced Acute Kidney Injury | Small molecule | Nephrology |CorMedix Inc.|Last Updated: Jun 27, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01146925Deferiprone for the Prevention of Contrast-Induced Acute Kidney InjuryPHASE2 COMPLETED 60Jun 1, 2010Jun 1, 2011Jun 27, 20118 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Biomarker evidence of Acute Kidney injury
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 Endpoints
Incidence of Acute Kidney Injury
48 hours
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CRMD-001-DeferiproneEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
CRMD-001-DeferiproneDRUGCRMD-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
PlaceboDRUG3 placebo tablets will be given every 12 hours for a total of 8 days, beginning 1-3 hours prior to angiography
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

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 ...

Countries:United States
Unlock Eligibility Criteria