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CRMD-001-Deferiprone

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

CRMD-001-Deferiprone · 1 trial · 1 indication

Phase 2 1
NCT01146925Deferiprone for the Prevention of Contrast-Induced Acute Kidney InjuryContrast-Induced Acute Kidney Injury
COMPLETED60 Analytics
PHASE2COMPLETED
Deferiprone for the Prevention of Contrast-Induced Acute Kidney Injury
Contrast-Induced Acute Kidney InjuryUnlock trial analytics

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
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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
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Eligibility Criteria

Age Range18 Years to 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
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Frequently asked questions about CRMD-001-Deferiprone

What is CRMD-001-Deferiprone used for?

CRMD-001-Deferiprone is an investigational small molecule being studied for the prevention of contrast-induced acute kidney injury, a form of kidney damage that can occur after receiving contrast agents during imaging procedures. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

What does CRMD-001-Deferiprone target?

CRMD-001-Deferiprone is an iron-chelating agent that works by binding to free iron in the body. By chelating iron, it may reduce oxidative stress and inflammation that contribute to contrast-induced acute kidney injury. This mechanism is being evaluated in clinical trials for its potential to protect kidney function.

Who makes CRMD-001-Deferiprone?

CRMD-001-Deferiprone is being developed by CorMedix Inc., a biopharmaceutical company. CorMedix is publicly traded on the New York Stock Exchange under the ticker symbol CRMD. The company is conducting clinical research to evaluate the safety and efficacy of this drug candidate.

What phase is CRMD-001-Deferiprone in?

CRMD-001-Deferiprone is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies for commercial use. The Phase 2 trial has been completed, and the drug is still undergoing clinical evaluation to determine its potential as a treatment.

What clinical trials is CRMD-001-Deferiprone in?

CRMD-001-Deferiprone has one completed Phase 2 clinical trial registered as NCT01146925, titled "Deferiprone for the Prevention of Contrast-Induced Acute Kidney Injury." This randomized, double-blind, placebo-controlled study enrolled 60 participants in the United States to evaluate the drug's safety and efficacy.

Is CRMD-001-Deferiprone the same as deferiprone?

CRMD-001-Deferiprone is a formulation of deferiprone, an iron-chelating agent. The drug candidate is being developed by CorMedix Inc. specifically for the prevention of contrast-induced acute kidney injury. Deferiprone itself is an established medication used for other conditions, but this specific formulation is under investigation for a new indication.