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A randomized controlled study to evaluate the efficacy and safety of rituximab in the treatment of elderly IGG4-related Kidney disease

A randomized controlled study to evaluate the efficacy and safety of rituximab in the treatment of elderly IGG4-related Kidney disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103574
Enrollment
Unknown
Registered
2025-05-30
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgG4-related kidney disease in the elderly

Interventions

Experimental group:Rituximab 1 g intravenous infusion is given at weeks 0 and 2. At 12 weeks, it is decided whether to add another 1 g depending on the status of B cell reconstitution.
Control group:Prednisone (or an equivalent dose of other glucocorticoids) at a starting dose of 0.8 g/kg/day orally is tapered according to the study protocol or adjusted according to the condition.

Sponsors

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age > = 60 years 2. Newly diagnosed IgG4RKD: including IgG4 interstitial nephritis and IgG4 membranous nephropathy 3. Have not received any IgG4-RD related treatment

Exclusion criteria

Exclusion criteria: 1. Presence of other major complications; 2. Definite diagnosis or secondary to other kidney diseases 3. Have used immunosuppressive therapy, including hormones or various immunosuppressants, in the past 3 months; 4. Presence of other contraindications to the use of hormones, such as necrosis of the femoral head, active gastrointestinal bleeding 5. Combined with other conditions affecting the use of rituximab: (1) Active or occult infection, including: active bacterial, fungal, tuberculosis infection, HBV, CMV and other viral infections or incubation periods; (2) History of allergy to rituximab components 6. Clinician judgment that the patient is unable to comply with the study protocol 7. Participate in other clinical trials at the same time

Design outcomes

Primary

MeasureTime frame
eGFR;Urine protein;

Countries

China

Contacts

Public ContactKe Zheng

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

kellyz_0_67@163.com+86 10 6915 5307

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026