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Efficacy and safety of multitarget therapy with cyclophosphamide and sirolimus for lupus nephritis: a single-arm, single-center pilot study

Efficacy and safety of multitarget therapy with cyclophosphamide and sirolimus for lupus nephritis: a single-arm, single-center pilot study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027957
Enrollment
Unknown
Registered
2019-12-07
Start date
2019-12-05
Completion date
Unknown
Last updated
2019-12-10

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

Conditions

lupus nephritis

Interventions

single arm:cyclophosphamide and sirolimus

Sponsors

The First Affiliated Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) the patients with SLE according to criteria for classification of SLICC in 2012; (2) 24-hour urine protein quantity >= 1.5g; (3) SLEDAI >= 8 points; (4) aged 18-65 years, gender unlimited; (5) signing the informed consent before the test; (6) CYC, MMF, tacrolimus, cyclosporine, leflunomide, Glucocorticoid (dose not more than 0.8mg/kg x d), human immunoglobulin or plasma exchange were not used 30 days before the test.

Exclusion criteria

Exclusion criteria: (1) kidney damage caused by other diseases, such as hypertensive nephropathy and diabetic nephropathy; (2) patients with immune deficiency, uncontrolled severe infection and active peptic ulcer; (3) pregnant women,lactating women and men or women with family planning in the past 12 months; (4) patients have a history of allergy to the test drug; (5) patients with active hepatitis or serious liver disease; (6) patients with serious heart, liver, kidney and other important organ lesions; (7) the researcher thinks that it is not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
SLEDAI;complete remission and partial remission;

Countries

China

Contacts

Public ContactPingting Yang

The First Affiliated Hospital of China Medical University

ypt1028@163.com+86 13904003875

Outcome results

None listed

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