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Research on the Efficacy and mechanism of Sirolimus in delaying IgG4-RKD renal fibrosis through PI3K/Akt/mTOR signaling pathway

Research on the Efficacy and mechanism of Sirolimus in delaying IgG4-RKD renal fibrosis through PI3K/Akt/mTOR signaling pathway

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078767
Enrollment
Unknown
Registered
2023-12-18
Start date
2023-02-15
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

IgG4-related Kidney Disease (IgG4RKD)

Interventions

1:Sirolimus 1mg/ day (Initial dose),target trough concentration 5-8µg/L

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-80 years old; male (2) IgG4-RKD patients diagnosed by renal biopsy pathology, and regularly followed-up rin our hospital; (3) The patient has completed induced remission therapy and entered the maintenance treatment stage; (4) Prednisone dose =<15mg/d (or equivalent of other glucocorticoids), other immunosuppressant doses stable for more than 4 weeks; (5) The patient or family member is able to understand the study protocol and is willing to participate in the study, providing written informed consent.

Exclusion criteria

Exclusion criteria: (1) The presence of metal in the body ; (2) Combined with IgG4-RD mimic diseases, such as vasculitis, hematological malignancy, etc.; (3) Have a birth plan in the near future (4) Obvious abnormal liver function; (5) Being in the state of kidney dialysis

Design outcomes

Primary

MeasureTime frame
eGFR;

Secondary

MeasureTime frame
serum IgG4;urine protein;renal MRI parameter-K value;renal MRI parameter-ADC value;

Countries

China

Contacts

Public ContactKe Zheng

Peking Union Medical College Hospital

kellyz_0_67@163.com+86 135 2007 0767

Outcome results

None listed

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