Pre-emptive Treatments in Lupus Nephritis Patients With Serological Reactivation

Lupus Nephritis Clinical Trial

Official title:

Pre-emptive Increase of Immunosuppressive Treatments in Lupus Nephritis Patients With Asymptomatic Serological Reactivation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04870359
• Other study ID #: UW-16-074
• Status: Recruiting
• Phase: N/A
• Start date: April 21, 2016
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2022
• Source: The University of Hong Kong
• Contact: Desmond YH YAP, MBBS (HK), MD (HK)
• Phone: 85222554385
• Email: desmondy[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Procedure:
• Pre-emptive increase of immunosuppressive treatments
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.

Drug:
• Prednisolone and/or AZA/MMF
Prednisolone and/or AZA/MMF

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital, Hong Kong	Hong Kong
Hong Kong	United Christian Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	United Christian Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Within 24 months
Secondary	Infections requiring hospitalization		24 months
Secondary	Extra-renal flares		24 months
Secondary	Serum creatinine levels		24 months
Secondary	Changes in anti-dsDNA		24 months
Secondary	Changes in C3		24 months
Secondary	Changes in Hba1c		24 months
Secondary	Changes in fasting glucose		24 months
Secondary	Changes in LDL levels		24 months