Study of Telitacicept in Patients With Refractory IgA Nephropathy

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

The goal of this clinical trial is to explore the effectiveness and safety of Telitacicept in adults with refractory IgA nephropathy.

The main questions it aims to answer are:

* To evaluate the clinical efficacy of Telitacicept in patients with refractory IgA nephropathy. * To evaluate the safety and adverse reaction of Telitacicept in patients with refractory IgA nephropathy.

Participants will be subcutaneously injected with 240mg of Telitacicept once per week.

Study subject: After 6 months of sequential treatment with renin-angiotensin system (RAS) blockers or glucocorticoids, patients with pathological biopsy of 0.7≥5 g/24 hours of proteinuria was confirmed as refractory IgA nephropathy.

Eligibility criteria

Qualifiers

Voluntarily sign the informed consent form.

IgA nephropathy was confirmed by pathological biopsy.

Age range: ≥ 18 years old, ≤ 70 years old, male or female.

During the screening period, the 24-hour urine protein of Visit 1 and Visit 2 should meet at least one ≥0.75g/24h, and the 24-hour urine protein ≥ 0.75g/24h at Visit 3.

Disqualifiers

Abnormal laboratory indicators of participants need to be excluded.

Secondary IgA nephropathy need to be excluded.

Specific pathologic or clinical renal disease types, and IgA nephropathy that may require hormone therapy.

Patients who have experienced any of the following cardiovascular and cerebrovascular events within the 12 weeks prior to screening.

Trial design

Treatments tested in this trial

  • Telitacicept

Treatment groups

40 Participants
are divided into 1 treatment group