Trial of the Impact of Sibeprenlimab on Immunoglobulin A... | NCT06740526

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

NCT06740526

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Status

Recruiting

Last Update Posted

Apr 6, 2025Actual

Enrollment

25Estimated

Phase

Phase 2

Conditions

IgA Nephropathy

Interventions

Sibeprenlimab

Countries

United States
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 19, 2024Actual

Primary Completion Date

Apr 17, 2029Estimated

Completion Date

Apr 17, 2029Estimated

First Submitted Date

Dec 13, 2024

First Submission Date that Met QC Criteria

Dec 13, 2024

First Posted Date

Dec 18, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2025

Last Update Posted Date

Apr 6, 2025Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Label	Type	Description	Intervention Names
Sibeprenlimab	Experimental		Drug: Sibeprenlimab

Name	Type	Description	Arm Group Labels	Other Names
Sibeprenlimab	Drug	Sibeprelimab SC (Period 1) Sibeprelimab SC (Period 2)	Sibeprenlimab

Measure	Description	Time Frame
Change from Baseline in Glomerular IgA Deposition by Immunofluorescence in Kidney Tissue to Week 52		From Baseline to Week 52

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants must be at least 16 years of age or older at the time of signing the informed consent/assent.
Source-verified kidney biopsy confirmed diagnosis of IgAN.
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:

Participants who are breast-feeding and/or who have a positive pregnancy test result prior to receiving sibeprenlimab.
Participant has coexisting chronic kidney disease, other than IgAN.
Participant has a serum IgG value <600 mg/dL at screening.
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).
Participant has uncontrolled hypertension (defined as systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg).
Participants who would be likely to require prohibited concomitant therapy during the trial.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Otsuka Call Center	Contact	844-687-8522		Otsuka-ProfessionalServices@otsuka-us.com

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Site 330	Recruiting	Denver	Colorado	80230	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.

Access Criteria

Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com

URL

http://clinical-trials.otsuka.com

ID	Term
D005921	Glomerulonephritis
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases