Pre-emptive Treatments in Lupus Nephritis Patients With Serological Reactivation

Lupus Nephritis Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

• NCT number: NCT04870359
• Study type: Interventional
• Source: The University of Hong Kong
• Contact: Desmond YH YAP, MBBS (HK), MD (HK)
• Phone: 85222554385
• Email: desmondy@hku.hk
• Status: Recruiting
• Phase: N/A
• Start date: April 21, 2016
• Completion date: March 31, 2023