Sirolimus in Treatment of Proteinuric Flares of Lupus Nephritis

• Status: Not yet recruiting
• Trial end date: 2023-10-30
• Target enrollment: 0
• Participant gender: All

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 immunosuppressive medication during 12-week follow-up.

Primary Objective:

• To investigate the efficacy of sirolimus for mild proteinuric flares in patients with Class III/IV±V lupus nephritis

Secondary Objective:

• To assess the safety and tolerability of sirolimus treatment for mild proteinuric flares in patients with Class III/IV±V lupus nephritis

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborator: North China Pharmaceutical Group Corporation
• Treatments: Sirolimus

Criteria

Inclusion Criteria:

• 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 :

1. 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

2. No hypoalbuminemia: serum albumin ≥35g/L

3. Stable renal function: serum creatinine<25% increase above the level at the time of renal disease remission

• Eligible to sign informed-consent independently

Exclusion Criteria:

• 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