Status:
UNKNOWN
Sirolimus in Treatment of Proteinuric Flares of Lupus Nephritis
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
North China Pharmaceutical Group Corporation
Conditions:
Lupus Nephritis
Immunosuppression
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
Brief Summary
This a single-centre, one-arm, open-label pilot study. Eligible patients with mild proteinuric flares of lupus nephritis Class III/IV±V are received sirolimus without changing previous immunosuppressi...
Detailed Description
Lupus nephritis is a common and serious complication of systemic lupus erythematosus (SLE). It often requires aggressive immunosuppressive therapy. Although majority of patients with severe lupus neph...
Eligibility Criteria
Inclusion
- Biopsy-proven Class III or IV±V lupus nephritis (ISN/RPS 2003 lupus nephritis classification) with biopsy performed within 48 weeks before inclusion.
- Males or females aged 18 to 60 years old at the time of screening.
- The mild proteinuric flare of lupus nephritis is defined as meeting all of the following criteria :
- Persistently increased proteinuria after complete remission, and 24-hr proteinuria≥1.0g/day or doubling of proteinuria after partial remission, and 24-hr proteinuria≥2.0g/day
- No hypoalbuminemia: serum albumin ≥35g/L
- Stable renal function: serum creatinine\<25% increase above the level at the time of renal disease remission
- Eligible to sign informed-consent independently
Exclusion
- Renal disease unrelated to SLE (e.g. diabetes mellitus, other glomerular or tubulointerstitial diseases, renovascular disease), or transplanted kidney
- Estimate glomerular filtration rate (eGFR by CKD-EPI)\<45mL/min per 1.73m\^2 at the time of screening
- Renal biopsy showing cellular of fibrocellular crescent in more than 25% of glomeruli
- Central nervous system (CNS) or other severe organ manifestations of lupus that necessitate aggressive immunosuppressive therapy on its own.
- Co-morbidities that require corticosteroid therapy (e.g. asthma, inflammatory bowel disease)
- Any increased dose of corticosteroids or other immunosuppressive medication including cyclophosphamide, mycophenolate, leflunomide, calcineurin inhibitors, azathioprine, methotrexate, or use of biological agents regardless of duration, with the past six months
- Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection history: seropositivity of HBV surface antigen (HBsAg) or HCV antibodies (HCV-Ab)
- Women who are pregnant or breastfeeding
- Women with childbearing potential or their male partners, who refuse to use an effective birth control method
Key Trial Info
Start Date :
June 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04892212
Start Date
June 30 2021
End Date
October 30 2023
Last Update
May 19 2021
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