NCT04870359

Pre-emptive Treatments in Lupus Nephritis Patients With Serological Reactivation

Pre-emptive Increase of Immunosuppressive Treatments in Lupus Nephritis Patients With Asymptomatic Serological Reactivation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The optimal management of asymptomatic serological reactivation (ASR) in lupus nephritis (LN) patients remained undefined. This project aims to investigate the impact of pre-emptive treatment on disease relapse in LN patients who experienced ASR.

Detailed description

LN patients who presented with ASR \[defined as 1) increase in anti-dsDNA \>100 IU/mL , with or without drop in serum complement; or 2) increase in anti-dsDNA to higher than the normal range and \>2 times of the preceding value, with or without drop in serum complement; and 3) Absence of renal or systemic manifestations of SLE) will be randomized to receive pre-emptive increase in immunosuppression or had their current immunosuppressive therapies unchanged. Patients will be followed at 4-, 12-, 24-wk and then every 12 weeks up to 24 months to monitor for renal or extra-renal relapses. Bloods and urine will be collected for measurement of renal and serological parameters, and also B cell signatures. Primary outcomes: Renal Flare (denoted as proteinuria \>1g/D; presence of urinary RBC \>30 hpf/RBC casts, or increase in SCr \>15% and positive anti-dsDNA) Secondary outcomes: * Safety \& tolerability of pre-emptive increase of immunosuppressive treatments * Extra-renal flares * Renal function at 24 months * Changes in serological parameters

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
PROCEDURE	Pre-emptive increase of immunosuppressive treatments	1. Increase prednisolone to 0.4-0.5 mg/kg/day; taper by 5 mg every 2 weeks to reach 15mg/day; then further reduce by 2.5 mg every 2 week and aim to reach 5-7.5 mg/day after 12 weeks. 2. Adjustment of the 2nd agent would be as follows: 1. For patients who receive AZA \<75mg/day; increase the dose of AZA to 75 mg/day. 2. For patients who receive MMF \<1g/day, increase the dose of MMF to 1g/day.
DRUG	Prednisolone and/or AZA/MMF	Prednisolone and/or AZA/MMF

Timeline

• Start date: 2016-04-21
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2021-05-03
• Last updated: 2024-12-16

Locations

2 sites across 1 country: Hong Kong