Telitacicept Efficacy and Safety in Pediatric IgA Nephropathy or IgA Vasculitis Nephritis Treatment
This clinical trial is investigating how well telitacicept works in treating children with IgA Nephropathy or IgA Vasculitis Nephritis, by observing changes in their 24-hour urinary protein levels.
Telitacicept
Urogenital Diseases+8
+ Autoimmune Diseases
+ Female Urogenital Diseases and Pregnancy Complications
Treatment Study
Summary
Study start date: August 1, 2025
Actual date on which the first participant was enrolled.This clinical trial is focused on understanding how effective and safe a new medication, Telitacicept, is for children suffering from two kidney-related conditions known as IgA Nephropathy and IgA Vasculitis Nephritis. These conditions can cause kidney damage and are particularly challenging for children aged 5 to 18. The study aims to discover if adding Telitacicept to standard treatment can better manage these conditions, potentially improving outcomes and providing a new option for children who might not respond well to existing therapies. Participants in the study will be split into two groups: one will receive the usual treatment plus Telitacicept, while the other will only receive the standard therapy. The treatment will last for 24 weeks, during which the main focus will be on how much the protein levels in urine change—a sign of how well the kidneys are functioning. Additional checks will include the urine protein-to-creatinine ratio and the estimated glomerular filtration rate (eGFR), alongside monitoring for any side effects of the drug. This helps ensure that the treatment is not only effective but also safe for the children involved.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.124 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 5 to 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Diagnosed with IgA nephropathy (IgAN) or IgA vasculitis nephritis (IgAVN) Aged 5 to 18 years Weight ≥25 kg Moderate or heavy proteinuria At enrollment, estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73m² calculated using the Schwartz formula (36.5 × height \[cm\] / serum creatinine \[μmol/L\]). Willing to sign the informed consent form Exclusion Criteria: * There is an ongoing infection that requires antiviral drugs or antibiotics for treatment. The patient has received other B cell-targeting biologics within the three months prior to enrollment. Patients with uncontrolled severe hypertension or diabetes. Individuals with other autoimmune diseases, primary immunodeficiencies, or tumors. A history of organ transplantation. Patients with chronic active infections, such as Epstein-Barr virus, cytomegalovirus, or Mycobacterium tuberculosis, whose disease state may be exacerbated by the use of steroids and immunosuppressive agents. Patients with severe liver failure, heart failure, or end-stage renal disease (ESRD). Any other medical conditions that may place the patient at increased risk by participating in this study. Individuals deemed by the investigator as unsuitable for participation in this study.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives