Clinical trial NCT04870359: Pre-emptive Treatments in Lupus Nephritis Patients With Serological Reactivation
Official title: Pre-emptive Increase of Immunosuppressive Treatments in Lupus Nephritis Patients With Asymptomatic Serological Reactivation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lupus Nephritis
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: United Christian Hospital
First posted: 2021-05-03
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Renal Flare
timeFrame: Within 24 months
Secondary outcomes:
measure: Infections requiring hospitalization
timeFrame: 24 months
measure: Extra-renal flares
timeFrame: 24 months
measure: Serum creatinine levels
timeFrame: 24 months
measure: Changes in anti-dsDNA
timeFrame: 24 months
measure: Changes in C3
timeFrame: 24 months
measure: Changes in Hba1c
timeFrame: 24 months
measure: Changes in fasting glucose
timeFrame: 24 months
measure: Changes in LDL levels
timeFrame: 24 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, Hong Kong
city: Hong Kong
country: Hong Kong
facility: United Christian Hospital
Study officials:
affiliation: Queen Mary Hospital, The University of Hong Kong
name: Desmond YH Yap, MBBS (HK). MD (HK)
role: PRINCIPAL_INVESTIGATOR
References: