Pre-emptive Treatments in Lupus Nephritis Patients With Serological Reactivation
NCT ID: NCT04870359
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
49 participants
INTERVENTIONAL
2016-04-21
2022-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pre-emptive Treatment (Prednisolone and/or AZA/MMF)
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.
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.
Prednisolone and/or AZA/MMF
Prednisolone and/or AZA/MMF
Control
Current immunosuppressive regimen and dosage should remain unchanged until the development of renal or extra-renal flares which required increase/change in immunosuppression.
No interventions assigned to this group
Interventions
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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.
Prednisolone and/or AZA/MMF
Prednisolone and/or AZA/MMF
Eligibility Criteria
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Inclusion Criteria
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
2. Patients whom the clinicians opined to have excessively high risk of infection or malignancy.
3. Patients who are pregnant or lactating.
18 Years
90 Years
ALL
No
Sponsors
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United Christian Hospital
OTHER
The University of Hong Kong
OTHER
Responsible Party
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Principal Investigators
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Desmond YH Yap, MBBS (HK). MD (HK)
Role: PRINCIPAL_INVESTIGATOR
Queen Mary Hospital, The University of Hong Kong
Locations
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Queen Mary Hospital, Hong Kong
Hong Kong, , Hong Kong
United Christian Hospital
Hong Kong, , Hong Kong
Countries
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Other Identifiers
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UW-16-074
Identifier Type: -
Identifier Source: org_study_id