Acthar for Treatment of Proteinuria in Diabetic Nephropathy Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

January 31, 2016

Study Completion Date

March 31, 2016

Conditions
Diabetic Nephropathy
Interventions
DRUG

Repository Corticotropin Injection

H.P. Acthar Gel (repository corticotropin injection) is administered via daily SC injection for 36 weeks in the three dose groups \[8 U (0.1 mL), 16 U (0.2 mL), or 32 U (0.4 mL)\].

DRUG

Placebo

Placebo contains the same inactive ingredients as H.P. Acthar Gel without the active pharmaceutical ingredient (API). Placebo is administered via daily SC injection for 36 weeks in equal volumes as the Acthar comparator volumes.

Trial Locations (10)

10461

Questcor Investigational Site, The Bronx

18017

Questcor Investigational Site, Bethlehem

33024

Questcor Investigational Site, Cooper City

33166

Questcor Investigational Site, Miami Springs

37408

Questcor Investigational Site, Chattanooga

43210

Questcor Investigational Site, Columbus

75402

Questcor Investigational Site, Greenville

77030

Questcor Investigational Site, Houston

78229

Questcor Investigational Site, San Antonio

95661

Questcor Investigational Site, Roseville

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mallinckrodt

INDUSTRY