New hope for kids with rare kidney disease: telitacicept vs. steroids
NCT ID NCT07354503
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether the drug telitacicept works better than standard steroids for children aged 3-17 with kidney inflammation caused by IgA vasculitis. About 300 participants will be followed for up to 48 weeks to see if their urine protein levels drop and kidney function stays stable. The goal is to give doctors a safer, more effective treatment option.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jan 2026
An estimate. Start dates often move.
- Expected to finish
-
Jun 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Collect patients diagnosed with childhood IgA vasculitis nephritis who received treatment with glucocorticoids and/or telitacicept during the treatment period and met the inclusion and exclusion criteria.
- Ages
-
3 to 17 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 3-17 years; 2. Patients diagnosed with IgA vasculitis nephritis (IgAVN) based on clinical manifestations and renal pathological diagnosis; 3. Urinary protein quantification requirements: urinary protein/creatinine ratio (UPCR) of ≥1 mg/mg (100 mg/mmol); 4. Estimated glomerular filtration rate (eGFR) calculated using the modified Schwartz formula of ≥60 mL/min/1.73 m². 5. Renal biopsy is optional (if a renal biopsy is performed, cases classified as International Society of Nephropathology (ISKDC) grade ≥IV must be excluded). Exclusion Criteria: 1. Patients with congenital or acquired immunodeficiency, or those with concurrent tuberculosis, active cytomegalovirus (CMV), Epstein-Barr virus(EBV), hepatitis B, hepatitis C, Human Immunodeficiency Virus(HIV) infection, deep fungal infections, or other active infections; 2. Patients exhibiting the following abnormal laboratory indicators at the time of initial diagnosis: moderate to severe neutropenia (≤1000/μL); moderate to severe anemia (hemoglobin \<9.0 g/dL); thrombocytopenia (platelet count \<100×10\^12/L); or abnormal liver function (Alanine Aminotransferase(ALT), Aspartate Aminotransferase(AST), or bilirubin exceeding 2.5 times the upper limit of normal and persistently elevated for 2 weeks); 3. Patients with a history of tumors or severe cardiovascular, digestive system, hematological, endocrine, or other systemic diseases; 4. Patients with concurrent other urinary system diseases (such as hereditary kidney diseases, etc.); 5. Subjects with severe osteoporosis requiring treatment; 6. Subjects diagnosed with uncontrolled mental illness or intellectual disabilities; 7. Subjects who have received B-cell targeted therapy within the last 6 months; 8. History of major organ transplant or hematopoietic stem cell/cell/bone marrow or kidney transplant; 9. Vaccination with live attenuated vaccines within 1 month prior to treatment; 10. Use of various traditional Chinese medicines for treating kidney diseases during the treatment period (patients who have previously used traditional Chinese medicine can be included, but are strictly prohibited from using it after receiving treatment according to the protocol); 11. Incomplete clinical data.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for IgA vasculitis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Blood test may spot hidden gut trouble in kids with rare disease
- New combo therapy aims to tame rare blood vessel disease
- Pregnancy and vasculitis: new study seeks answers
- Skin biopsies shed light on rare blood vessel disease
- Which drug tames skin vasculitis best? new trial aims to find out
- Scientists build tissue bank to unlock vasculitis mysteries