Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue
NCT ID: NCT06740526
Last Updated: 2025-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
25 participants
INTERVENTIONAL
2024-11-19
2029-04-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Sibeprenlimab
Sibeprenlimab
Sibeprelimab SC (Period 1)
Sibeprelimab SC (Period 2)
Interventions
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Sibeprenlimab
Sibeprelimab SC (Period 1)
Sibeprelimab SC (Period 2)
Eligibility Criteria
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Inclusion Criteria
2. Source-verified kidney biopsy confirmed diagnosis of IgAN.
3. Participant has estimated glomerular filtration rate (eGFR) \> 45 mL/min/1.73 m2 using serum creatinine (Chronic Kidney Disease-Epidemiology Collaboration \[CKD EPI\] creatinine eGFR 2021 equation for those 18 years and older; Chronic Kidney Disease in Children under age 25 \[CKiD U25\] eGFR equation for those younger than 18 years)
Exclusion Criteria
2. Participant has coexisting chronic kidney disease, other than IgAN.
3. Participant has a serum IgG value \<600 mg/dL at screening.
4. Participant is currently receiving or has received within 24 weeks prior to the firstdose of sibeprenlimab, systemic corticosteroids or immunosuppression (note:
topical, ophthalmic, rectal, intra-articular, inhaled corticosteroids are allowed).
5. Participant has uncontrolled hypertension (defined as systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg).
6. Participants who would be likely to require prohibited concomitant therapy during the trial.
16 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Research Site 330
Denver, Colorado, United States
Clinical Research Site 369
Boston, Massachusetts, United States
Clinical Research Site 374
Dakota Dunes, South Dakota, United States
Clinical Research Site 324
Houston, Texas, United States
Clinical Research Site 305
Scarborough Village, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Otsuka Call Center
Role: primary
Otsuka Call Center
Role: primary
Otsuka Call Center
Role: primary
Otsuka Call Center
Role: primary
Otsuka Call Center
Role: primary
Other Identifiers
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417-201-00060
Identifier Type: -
Identifier Source: org_study_id
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