Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) Nephropathy

Part of paid clinical trials in Palo Alto, California.

Sponsor
Rigel Pharmaceuticals
Study ID
NCT02112838
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Fostamatinib 150 mg — DRUG
    Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks
  • Fostamatinib 100 mg — DRUG
    Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks
  • Placebo — DRUG
    Placebo tablet twice daily by mouth, over the course of 24 weeks

Study Details

The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of IgA Nephropathy

Key Dates

Start date
Oct 31, 2014
Status verified
Jun 2019
Primary completion
Mar 23, 2018
Completion
Nov 12, 2018

Study Design

Enrollment
76 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Fostamatinib 150 mg
    Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks
  • Active Comparator: Fostamatinib 100 mg
    Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks
  • Placebo Comparator: Placebo
    Placebo tablet twice daily by mouth, over the course of 24 weeks

Primary Outcome Measure

Mean Change of Proteinuria as Measured by Spot Urine Protein/Creatinine Ratio (sPCR) at Week 24 [ Time Frame: Baseline to 24 weeks ]

Locations (4)

FacilityCityStateZIPSite coordinators
Stanford University MedicalPalo AltoCalifornia94304-
Nephrology Associates PC, University Hospital, Professional Center 1AugustaGeorgia30901-
Ohio State UniversityColumbusOhio43210-
Southeast Renal Research InstituteChattanoogaTennessee37408-

Find similar trials in Palo Alto, CA

By research site
Stanford University Medical· Palo Alto, CANephrology Associates PC, University Hospital, Professional Center 1· Augusta, GAOhio State University· Columbus, OHSoutheast Renal Research Institute· Chattanooga, TN

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