UnknownPhase 2/3

Sirolimus in Treatment of Proteinuric Flares of Lupus Nephritis

20 participantsStarted 2021-06-30

Plain-language 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

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion 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

What they're measuring

The number of patients achieving sustained Renal Response(RR)

Timeframe: at the end of 12 weeks (3 months) from baseline

Trial details

NCT IDNCT04892212

SponsorPeking Union Medical College Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-30

Contact for this trial

Chao Li, MD

86-010-69155058 superchad099@hotmail.com

View on ClinicalTrials.gov More Lupus Nephritis trials