Efficacy and Safety of Telitacicept in IgAN

Sponsor
Ruijin Hospital
Study ID
NCT06654596
Status
Recruiting
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Conditions

  • Glucocorticoid
  • IgA Nephropathy (IgAN)
  • Kidney Diseases
  • Telitacicept

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Telitacicept 240mg — DRUG
    Patients in telitacicept group will be treated with maximum tolerable dose of angiotensin converting enzyme inhibitor ( ACEI ) and/or angiotensin II receptor blocker ( ARB ) combined with telitacicept. 240 mg telitacicept will be used once a week for 40 weeks.
  • Glucocorticoid — DRUG
    Patients in glucocorticoid group will be treated with ACEI/ARB and glucocorticoid ( prednisone/prednisolone) 0.5mg/kg (maximum 40mg/d). After 8 weeks, reduce the dosage by 5 mg per month for a total of 28-40 weeks.

Study Details

A study to evaluate efficacy and safety of telitacicept in the treatment of patients with primary IgA nephropathy at high risk of progression.

Key Dates

Start date
Dec 6, 2024
Status verified
Dec 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
118 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Telitacicept+ACEI/ARB
  • Active Comparator: Glucocorticoids+ACEI/ARB

Primary Outcome Measure

Change of 24-hour urine protein [ Time Frame: From baseline to week 40 ]

Central Contacts

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