Lupus Nephritis
Conditions
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
Interventions
PROCEDUREPre-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.
DRUGPrednisolone and/or AZA/MMF
Prednisolone and/or AZA/MMF
Sponsors
United Christian Hospital
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients with biopsy-proven lupus nephritis who experienced an episode of Asymptomatic Serological Flare (ASF) as defined by: 1. Increase in anti-dsDNA to \>100 IU/mL, with or without drop in serum complement levels OR 2. Increase in anti-dsDNA to higher than the normal range and more than two times of the preceding value, with or without drop in serum complement levels AND 3. Absence of renal or systemic manifestation of SLE.
Exclusion criteria
1. Patients who cannot provide informed consent. 2. Patients whom the clinicians opined to have excessively high risk of infection or malignancy. 3. Patients who are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal Flare | Within 24 months | A composite endpoint denoted by proteinuria \>1g/day, presence of urinary RBC \>30/hpf or RBC casts, or increase in serum creatinine by 15% compared with baseline, and anti-DNA antibody titre above the upper limit of normal |
Secondary
| Measure | Time frame |
|---|---|
| Extra-renal flares | 24 months |
| Serum creatinine levels | 24 months |
| Changes in anti-dsDNA | 24 months |
| Infections requiring hospitalization | 24 months |
| Changes in Hba1c | 24 months |
| Changes in fasting glucose | 24 months |
| Changes in LDL levels | 24 months |
| Changes in C3 | 24 months |
Countries
Hong Kong
Outcome results
None listed