Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04870359
Status:
UNKNOWN
Last Update Posted:
2022-07-26
First Post:
2017-07-03
Brief Title:
Pre-emptive Treatments in Lupus Nephritis Patients With Serological Reactivation
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
Pre-emptive Increase of Immunosuppressive Treatments in Lupus Nephritis Patients With Asymptomatic Serological Reactivation
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
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 IUmL 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 1gD presence of urinary RBC 30 hpfRBC 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 1gD presence of urinary RBC 30 hpfRBC 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?:
None