RECRUITING

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

Description

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.

Conditions

IgA Nephropathy
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Related Conditions:

IgA Nephropathy

Study Overview

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Study Details

Study overview

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.

A Phase 2b, Multicenter, Open-label, Single-arm Trial to Evaluate the Impact of Sibeprenlimab on Kidney Histopathology Through Repeat Kidney Biopsies in Adolescents and Adults With Immunoglobulin A Nephropathy

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

Condition
IgA Nephropathy
Intervention / Treatment

-

Contacts and Locations

New York

For Additional Information Regarding Sites Contact 844-687-8522, New York, New York, United States, 10001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Participants must be at least 16 years of age or older at the time of signing the informed consent/assent.
  • 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)
  • 1. Participants who are breast-feeding and/or who have a positive pregnancy test result prior to receiving sibeprenlimab.
  • 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:
  • 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.

Ages Eligible for Study

16 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Otsuka Pharmaceutical Development & Commercialization, Inc.,

Study Record Dates

2029-04-17