NCT04870359

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2017

Completed
3.8 years until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

5.9 years

First QC Date

July 3, 2017

Last Update Submit

December 13, 2024

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Infections requiring hospitalization

    24 months

  • Extra-renal flares

    24 months

  • Serum creatinine levels

    24 months

  • Changes in anti-dsDNA

    24 months

  • Changes in C3

    24 months

  • +3 more secondary outcomes

Study Arms (2)

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.

Procedure: Pre-emptive increase of immunosuppressive treatmentsDrug: 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.

Interventions

Pre-emptive increase of immunosuppressive treatmentsPROCEDURE

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 Treatment (Prednisolone and/or AZA/MMF)
Prednisolone and/or AZA/MMFDRUG

Prednisolone and/or AZA/MMF

Pre-emptive Treatment (Prednisolone and/or AZA/MMF)

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Queen Mary Hospital, Hong Kong

Hong Kong, Hong Kong

Location

United Christian Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLupus Erythematosus, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Desmond YH Yap, MBBS (HK). MD (HK)

    Queen Mary Hospital, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2017

First Posted

May 3, 2021

Study Start

April 21, 2016

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

December 16, 2024

Record last verified: 2024-12

Locations

HK(2)