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Visionary Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05248646
Recruitment Status : Recruiting
First Posted : February 21, 2022
Last Update Posted : March 10, 2023
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
This is a phase 3 study to evaluate effects on proteinuria and glomerular filtration rate of sibeprenlimab 400 mg subcutaneously (s.c.) Q 4 weeks in adults with IgAN who are receiving maximally tolerated standard-of-care therapy.

Condition or disease Intervention/treatment Phase
Immunoglobulin A Nephropathy Drug: Sibeprenlimab 400 mg Drug: Placebo Phase 3

Detailed Description:
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sibeprenlimab 400 mg administered SC Q 4 weeks compared to placebo in patients with IgAN. The primary objective is to compare the relative change from baseline in the urinary protein to creatinine ratio (uPCR) in 24-hour urine collections, after 9 months of treatment. The key secondary objective is to compare the annualized rate of change from baseline (slope) of estimated glomerular filtration rate (eGFR) after approximately 24 months of treatment. There will be one main cohort comprised of approximately 450 subjects with source-verified biopsy-confirmed IgAN and eGFR ≥ 30 mL/min/1.73 m^2. An additional exploratory cohort will be comprised of up to 20 subjects with source-verified biopsy confirmed IgAN and eGFR of 20 to < 30 mL/min/1.73 m^2.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 470 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects With Immunoglobulin A Nephropathy.
Actual Study Start Date : March 15, 2022
Estimated Primary Completion Date : December 30, 2026
Estimated Study Completion Date : December 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Active Comparator: Sibeprenlimab 400 mg s.c. q 4weeks Drug: Sibeprenlimab 400 mg
Sibeprenlimab 400 mg s.c. q 4 weeks
Other Name: VIS649

Placebo Comparator: Placebo Drug: Placebo
Placebo s.c. q 4 weeks

Primary Outcome Measures :
  1. Urinary protein to creatinine ratio (uPCR) in a 24-hour collection [ Time Frame: At 9 months ]

Secondary Outcome Measures :
  1. Annualized rate of change from baseline (slope) of eGFR [ Time Frame: Over 24 months ]
  2. Proportion of subjects achieving urine total protein < 1.0 g/day and ≥ 25% reduction from baseline. [ Time Frame: At 12 months ]
  3. Annualized slope of eGFR [ Time Frame: Over 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and female patients ≥ 18 years of age .
  • Biopsy-confirmed IgAN. (Patients with an eGFR of 30 to 45 mL/min/1.73m2 must have had a kidney biopsy performed within 36 months of the screening visit).
  • Stable and maximally tolerated dose of ACEI and/or ARB for at least 3 months prior to screening. Patients who are on a stable dose of SGLT2i may participate if treatment was initiated ≥3 months prior to screening. Patients who are unable to take an ACEI or ARB may participate if their overall management conforms with standards of care and other protocol requirements.
  • Screening urine protein/creatinine ratio (uPCR) ≥ 0.75 g/g or urine protein ≥ 1.0 g/day
  • eGFR ≥ 30 mL/min/1.73 m2, (for the exploratory cohort only: eGFR 20- <30 mL/min/1.73 m2), calculated using the CKD-EPI equation.)

Exclusion Criteria:

  • Secondary forms of IgAN or IgA vasculitis.
  • Coexisting chronic kidney disease other than IgAN.
  • Kidney biopsy findings in addition to IgAN including those of diabetic nephropathy, membranous nephropathy, or lupus nephritis. Hypertensive vascular changes are acceptable.
  • Kidney biopsy MEST or MEST-C score of T2 or C2 (Oxford IgAN classification). If MEST-scoring was not performed, the presence of > 50% tubulo-interstitial fibrosis, or crescents in > 25% of glomeruli is exclusionary. This does not apply to the exploratory cohort.
  • Nephrotic syndrome
  • Serum IgG < 600 mg/dL at screening.
  • Chronic systemic immunosuppression, including glucocorticoids, within 16 weeks of randomization
  • Participation in another interventional clinical trial and receipt of another investigational drug within 30 days prior to the administration of IMP or 5 half-lives from last investigational drug administration, whichever is longer.
  • Chronic infectious disease, or acute infectious disease at time of screening.
  • Type 1 diabetes, or poorly controlled Type 2 diabetes
  • Uncontrolled hypertension

The protocol provides additional information about these and other inclusion and exclusion criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05248646

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Contact: Otsuka Call Center 844-687-8522

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United States, New York
For additional information regarding sites, contact 844-687-8522 Recruiting
New York, New York, United States, 10001
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc. Identifier: NCT05248646    
Other Study ID Numbers: 417-201-00007
First Posted: February 21, 2022    Key Record Dates
Last Update Posted: March 10, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
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 the Vivli data sharing platform which can be found here:

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Autoimmune Diseases
Immune System Diseases