Study of the Telitacicept in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome (STERN)

August 20, 2024 updated by: Mao Jianhua, The Children's Hospital of Zhejiang University School of Medicine
The main objective is to evaluate the effectiveness of telitacicept in pediatric patients with frequently relapsing or steroid dependent nephrotic syndrome within the 52-week follow-up.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Nephrotic syndrome(NS) is the most common glomerular disease in children. Approximately 45-50% of patients with nephrotic syndrome exhibit frequent relapses or are dependent on steroid therapy. Frequent relapses or steroid dependence in nephrotic syndrome have been challenging issues for clinicians. Long-term, repeated, and high-dose oral steroid use can lead to side effects such as obesity, delayed development, hypertension, diabetes, glaucoma, osteoporosis, and increased susceptibility to infections. The addition of traditional immunosuppressants such as cyclophosphamide and tacrolimus can cause severe and irreversible side effects. Therefore, exploring new drugs and their application protocols is particularly important. Telitacicept has a unique dual-target mechanism that can inhibit B cell maturation and differentiation at multiple stages, thereby inhibiting B cell activity. Clinical studies have confirmed its significant efficacy in various kidney diseases, such as lupus nephritis, IgA nephropathy, and adult recurrent minimal change nephrotic syndrome; moreover, it has good safety profiles.

Therefore, through this prospective, single-center, open-label clinical trial, we aim to evaluate whether telitacicept provides superior efficacy compared to existing conventional treatment regimens for childhood frequent relapse (FR) or steroid-dependent (SD) nephrotic syndrome (NS), and assess its safety profile. Our goal is to provide an optimized treatment plan for childhood FRNS or SDNS.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Children's Hospital, Zhejiang University School of Medicine
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Sensitive but frequent relapses or steroids dependence nephrotic syndrome
  • Age: 2 to 18 years old
  • Normal renal function: estimated glomerular filtration rate ≥90ml/ min/1.73m2
  • Morning urine protein <1+ or urine protein-creatinine ratio <0.2g/g (<20 mg/ mmol) for 3 consecutive days and above when in enroll
  • No rituximab was used within 6 months, no tacrolimus, mycophenolate mofetil, cyclosporine A, or cyclophosphamide was used within 3 months, no ACTH was used within 3 months prior to the enrollment

Exclusion Criteria:

  • Family history of nephrotic syndrome, chronic glomerulonephritis or uremia
  • Leukopenia (White Blood Cells ≤ 3.0 * 10^9 / L)
  • Moderate to severe anemia (hemoglobin <9.0 g/dL)
  • Thrombocytopenia (platelet count <100*10^12/L)
  • Positive Hepatitis B virus serological indicators (Hepatitis B surface antigen or / and Hepatitis B virus e antigen or / and Hepatitis B core antibody), Hepatitis C virus-positive or patients with abnormal liver function (2 or more times of alamine aminotransferase or total bilirubin was exceeded the normal value, and continued to rise for 2 weeks)
  • There are chronic active infections such as Epstein-Barrvirus, cytomegalovirus or Mycobacterium tuberculosis, and the usage of steroids and immunosuppressive agents may aggravate the state of an illness
  • Secondary nephrotic syndrome (such as purpuric nephritis, lupus nephritis, etc.)
  • Those who with hematological or endocrine system diseases as well as serious organs illness such as heart, liver or kidney
  • Those who with other autoimmune diseases or primary immunodeficiencies or tumors
  • Those who have participated in other clinical trials within three months prior to the enrollment
  • Those who was not suitable for participating this study judged by investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telitacicept group
Weekly administration (administration time can be within 1 week + 3 days). Body weight and dosage: for subjects with body weight greater than 10kg and less than or equal to 20kg, the dose of Telitacicept is 40mg; for subjects with body weight greater than 20kg and less than or equal to 40kg, the dose of Telitacicept is 80mg; for subjects with body weight greater than 40kg and less than or equal to 60kg, the dose of Telitacicept is 120mg; for subjects with body weight greater than or equal to 60kg, the dose of Telitacicept is 160mg. Treatment duration: 52 weeks.
Drug: Telitacicept
The study duration was 52 weeks, with the experimental group receiving subcutaneous injections of Telitacicept once weekly for a total of 52 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year relapse-free survival rate
Time Frame: 1-year period after enrollment
The rate of no relapse within 1 year
1-year period after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse of nephrotic syndrome during 12 months after enrollment
Time Frame: 1-year period after enrollment
Proportion of patients with one or more relapse(s) of nephrotic syndrome
1-year period after enrollment
Number of relapses during 12 months follow up
Time Frame: 1-year period after enrollment
Number of nephrotic syndrome relapses per patient year during the 12 months period after enrollment
1-year period after enrollment
The first time to relapse
Time Frame: 1-year period after enrollment
The first time to relapse after patients taking part in this study
1-year period after enrollment
Cumulative prednisone dosage (milligrams per kilogram per year)
Time Frame: 1-year period after enrollment
The total dosage of prednisones from the beginning to the end of the trial
1-year period after enrollment
Change in hemoglobin of the patients
Time Frame: 1-year period after enrollment
The changes of hemoglobin (g/L) in each follow-up during the study
1-year period after enrollment
Change in blood albumin of the patients
Time Frame: 1-year period after enrollment
The changes of blood albumin (g/L）in each follow-up during the study
1-year period after enrollment
Change in renal function of the patients
Time Frame: 1-year period after enrollment
The change for renal function was judged by the changes of estimated glomerular filtration rate (eGFR in ml/min/1.73m^2) in each follow-up during the study
1-year period after enrollment
Change in mass index (BMI) during 12-month period after enrollment
Time Frame: 1-year period after enrollment
Changes in standard deviation scores for weight (Wt in kilograms), height (Ht in meters) will be combined to report body mass index (BMI in kg/m^2) during 12-month period after enrollment
1-year period after enrollment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse event
Time Frame: 1-year period after enrollment
The number of harmful reactions and the types of adverse events during the study
1-year period after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Children's Hospital of Zhejiang University School of Medicine

Investigators

  • Principal Investigator: Jianhua Mao, MD, Children's Hospital, Zhejiang University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

November 28, 2023

Primary Completion (Estimated)

October 24, 2026

Study Completion (Estimated)

October 24, 2027

Study Registration Dates

First Submitted

October 24, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Actual)

November 9, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STERN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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