Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue

Part of paid clinical trials in Denver, Colorado.

Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study ID
NCT06740526
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sibeprenlimab — DRUG
    Sibeprelimab SC (Period 1) Sibeprelimab SC (Period 2)

Study Details

This is a phase 2b open-label trial to characterize histopathological biomarkers of disease in immunoglobulin A nephropathy (IgAN) and demonstrate potential changes in response to sibeprenlimab.

Key Dates

Start date
Nov 19, 2024
Status verified
Dec 2024
Primary completion
Apr 17, 2029
Completion
Apr 17, 2029

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sibeprenlimab

Primary Outcome Measure

Change from Baseline in Glomerular IgA Deposition by Immunofluorescence in Kidney Tissue to Week 52 [ Time Frame: From Baseline to Week 52 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Clinical Research Site 330DenverColorado80230
Otsuka Call Center
Clinical Research Site 369BostonMassachusetts21144
Otsuka Call Center
Clinical Research Site 374Dakota DunesSouth Dakota57409
Otsuka Call Center
Clinical Research Site 324HoustonTexas77054
Otsuka Call Center

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