RECRUITING

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

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Conditions

IgA Nephropathy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-11-19
Study Completion:2029-04-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06740526

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.

Ages Eligible for Study:16 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participants must be at least 16 years of age or older at the time of signing the informed consent/assent.
  2. 2. Source-verified kidney biopsy confirmed diagnosis of IgAN.
  3. 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. 1. Participants who are breast-feeding and/or who have a positive pregnancy test result prior to receiving sibeprenlimab.
  2. 2. Participant has coexisting chronic kidney disease, other than IgAN.
  3. 3. Participant has a serum IgG value \<600 mg/dL at screening.
  4. 4. Participant is currently receiving or has received within 24 weeks prior to the firstdose of sibeprenlimab, systemic corticosteroids or immunosuppression (note:
  5. 5. Participant has uncontrolled hypertension (defined as systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg).
  6. 6. Participants who would be likely to require prohibited concomitant therapy during the trial.

Contacts and Locations

Study Contact

Otsuka Call Center
CONTACT
844-687-8522
OtsukaUS@druginfo.com

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-19
Study Completion Date2029-04-17

Study Record Updates

Study Start Date2024-11-19
Study Completion Date2029-04-17

Terms related to this study

Additional Relevant MeSH Terms

  • IgA Nephropathy