Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2026-01-01 @ 9:13 AM
Study NCT ID:
NCT04870359
Status:
COMPLETED
Last Update Posted:
2024-12-16
First Post:
2017-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-emptive Treatments in Lupus Nephritis Patients With Serological Reactivation
Sponsor:
The University of Hong Kong
Organization:
Study Overview
Official Title:
Pre-emptive Increase of Immunosuppressive Treatments in Lupus Nephritis Patients With Asymptomatic Serological Reactivation
Status:
COMPLETED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: