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Pyridoxamine

Phase 2

Diabetic Nephropathy | Small molecule | Nephrology |Medpace Holdings, Inc. Common Stock|Last Updated: Oct 28, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment317

FDA Designations

No designations recorded

Clinical trial landscape

Pyridoxamine · 1 trial · 1 indication

Phase 2 1
NCT00734253Safety and Efficacy Study of Pyridorin in Patients With Nephropathy Due to Type 2 DiabetesDiabetic Nephropathy
COMPLETED317 Analytics
PHASE2COMPLETED
Safety and Efficacy Study of Pyridorin in Patients With Nephropathy Due to Type 2 Diabetes
Diabetic NephropathyUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in serum creatinine from baseline to end of study.
1 year

Secondary Endpoints

SCr slope, change in PCR, Cystatin C slope and change from baseline.
1 Year
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTALPyridorin 150 mg bid
2EXPERIMENTALPyridorin 300 mg bid
3PLACEBO_COMPARATORPlacebo bid

Interventions

NameTypeDescription
Pyridoxamine DihydrochlorideDRUG150 mg capsules taken orally twice a day for 1-year.
PlaceboDRUGPlacebo capsules taken twice a day for 1-year
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Eligibility Criteria

Age Range25 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

INCLUSION CRITERIA: 1. Patients who have given voluntary written consent to participate in this study prior to conducting Screening Visit procedures; 2. Male and female patients 25 years of age or older with a diagnosis of type 2 diabetes; • If a woman is of childbearing potential (WOCBP) she must ...

Countries:United States
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Competitive Landscape -Diabetic Nephropathy 8 trials

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