Lupus NephritisNCT04870359
Pre-emptive Treatments in Lupus Nephritis Patients With Serological Reactivation
A study testing Pre-emptive increase of immunosuppressive treatments and Prednisolone and/or AZA/MMF in people with Lupus Nephritis, run by The University of Hong Kong at 2 sites in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Pre-emptive increase of immunosuppressive treatments and Prednisolone and/or AZA/MMF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesHong Kong
- Study dates
- 21 Apr 2016to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with biopsy-proven lupus nephritis who experienced an episode of Asymptomatic Serological Flare (ASF) as defined by:
- Increase in anti-dsDNA to >100 IU/mL, with or without drop in serum complement levels OR
- 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
- Absence of renal or systemic manifestation of SLE.
Who cannot join
- Patients who cannot provide informed consent.
- Patients whom the clinicians opined to have excessively high risk of infection or malignancy.
- Patients who are pregnant or lactating.
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Queen Mary Hospital, Hong Kong
Hong Kong
United Christian Hospital
Hong Kong
About this study
Official title: Pre-emptive Increase of Immunosuppressive Treatments in Lupus Nephritis Patients With Asymptomatic Serological Reactivation
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.
Read the 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
- Conditions
- Lupus Nephritis
- Being tested
- Pre-emptive increase of immunosuppressive treatments, Prednisolone and/or AZA/MMF
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-emptive increase of immunosuppressive treatmentsProcedure or surgery
- 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.
- Adjustment of the 2nd agent would be as follows:
- For patients who receive AZA <75mg/day; increase the dose of AZA to 75 mg/day.
- For patients who receive MMF <1g/day, increase the dose of MMF to 1g/day.
Prednisolone and/or AZA/MMFDrug
Prednisolone and/or AZA/MMF
| Study group | Role | What they receive |
|---|---|---|
| Pre-emptive Treatment (Prednisolone and/or AZA/MMF) | Active comparator | 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. Receives: Procedure: Pre-emptive increase of immunosuppressive treatments; Drug: Prednisolone and/or AZA/MMF |
| Control | No intervention | Current immunosuppressive regimen and dosage should remain unchanged until the development of renal or extra-renal flares which required increase/change in immunosuppression. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Flare
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
Measured: Within 24 months
Secondary outcomes (8)
Infections requiring hospitalization
Measured: 24 months
Extra-renal flares
Measured: 24 months
Serum creatinine levels
Measured: 24 months
Changes in anti-dsDNA
Measured: 24 months
Changes in C3
Measured: 24 months
Changes in Hba1c
Measured: 24 months
Changes in fasting glucose
Measured: 24 months
Changes in LDL levels
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start21 Apr 2016
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- United Christian Hospital
- Responsible party
- Sponsor
- Investigators
- Desmond YH Yap, MBBS (HK). MD (HK), Principal investigator, Queen Mary Hospital, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870359
- Sponsor's protocol ID
- UW-16-074
- Status last verified
- Dec 2024
- First submitted
- 3 Jul 2017
- Last updated
- 16 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yap DYH, Chan SCW, Wong PYH, Wong S, Zhang D, Yung S, Lo JMW, Lau CS, Tang C, Chan TM. A prospective multicenter randomized controlled trial pre-emptive increase in immunosuppression for asymptomatic serological reactivation in patients with lupus nephritis in clinical remission. Kidney Int. 2026 Jul;110(1):245-254. doi: 10.1016/j.kint.2026.02.037. Epub 2026 Mar 27.
PubMed 41905595
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-emptive Increase of Immunosuppressive Treatments in Lupus Nephritis Patients With Asymptomatic Serological Reactivation
- ClinicalTrials.gov ID
- NCT04870359
- Acronym / sponsor ID
- UW-16-074
- Conditions
- Lupus Nephritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- United Christian Hospital
- Study start
- 21 Apr 2016 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-emptive Treatment (Prednisolone and/or AZA/MMF) | Active comparator | Procedure: Pre-emptive increase of immunosuppressive treatments, Drug: Prednisolone and/or AZA/MMF1. 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. |
| Control | No intervention | –Current immunosuppressive regimen and dosage should remain unchanged until the development of renal or extra-renal flares which required increase/change in immunosuppression. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with biopsy-proven lupus nephritis who experienced an episode of Asymptomatic Serological Flare (ASF) as defined by:
- AND
Key exclusion criteria (3 listed)
- Patients who cannot provide informed consent.
- Patients whom the clinicians opined to have excessively high risk of infection or malignancy.
- Patients who are pregnant or lactating.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-emptive increase of immunosuppressive treatments1. 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. | Procedure or surgery | Pre-emptive Treatment (Prednisolone and/or AZA/MMF) |
| Prednisolone and/or AZA/MMFPrednisolone and/or AZA/MMF | Drug | Pre-emptive Treatment (Prednisolone and/or AZA/MMF) |
Primary outcome
Renal Flare
Time frame: 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
8 secondary outcomes
Infections requiring hospitalization
Time frame: 24 months
Extra-renal flares
Time frame: 24 months
Serum creatinine levels
Time frame: 24 months
Changes in anti-dsDNA
Time frame: 24 months
Changes in C3
Time frame: 24 months
Changes in Hba1c
Time frame: 24 months
Changes in fasting glucose
Time frame: 24 months
Changes in LDL levels
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Derived from this study: PubMed 41905595Yap DYH, Chan SCW, Wong PYH, Wong S, Zhang D, Yung S, Lo JMW, Lau CS, Tang C, Chan TM. A prospective multicenter randomized controlled trial pre-emptive increase in immunosuppression for asymptomatic serological reactivation in patients with lupus nephritis in clinical remission. Kidney Int. 2026 Jul;110(1):245-254. doi: 10.1016/j.kint.2026.02.037. Epub 2026 Mar 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Desmond YH Yap, MBBS (HK). MD (HK) principal investigator
Queen Mary Hospital, The University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-emptive increase of immunosuppressive treatments and Prednisolone and/or AZA/MMF in people with Lupus Nephritis, run by The University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal Flare (time frame: Within 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04870359, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.