Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study ID
NCT05248659
Phase
PHASE2/PHASE3
Status
Enrolling By Invitation

Conditions

  • Immunoglobulin A Nephropathy

Eligibility Criteria

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

Interventions

  • Sibeprenlimab 400 mg s.c. Q4weeks — DRUG
    Sibeprenlimab 400 mg s.c. q 4 weeks

Study Details

To evaluate the long-term safety and tolerability of sibeprenlimab in subjects with IgAN

Key Dates

Start date
Apr 5, 2022
Status verified
Apr 2026
Primary completion
Dec 28, 2028
Completion
Dec 31, 2029

Study Design

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

Arms

  • Experimental: Sibeprenlimab 400 mg s.c. q 4 weeks

Primary Outcome Measure

Adverse Events [ Time Frame: From baseline to the end-of-trial visit in Week 112. ]

Locations (15)

FacilityCityStateZIPSite coordinators
Clinical Research Site #336BirminghamAlabama35233-
Clinical Research Site #325Los AngelesCalifornia90027-
Clinical Research Site #370Palo AltoCalifornia94304-
Clinical Research Site #330DenverColorado80220-
Clinical Research Site #323Lauderdale LakesFlorida33313-
Clinical Research Site #373AtlantaGeorgia30342-
Clinical Research Site #356LawrencevilleGeorgia30046-
Clinical Research Site #369BostonMassachusetts02114-
Clinical Research Site #331WorcesterMassachusetts01655-
Clinical Research Site #320ShelbyMichigan48315-
Clinical Research Site #346Great NeckNew York11021-
Clinical Research Site #350ColumbusOhio43210-
Clinical Research Site #374Dakota DunesSouth Dakota57029-
Clinical Research Site #324HoustonTexas77030-
Clinical Research Site #361MilwaukeeWisconsin53213-

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