Last updated: 08/13/2024 04:30:09

Real-World Effectiveness of Belimumab in Lupus Nephritis

GSK study ID
219101
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Real-worlD Effectiveness of Belimumab amOng lUpus Nephritis Patients in Taiwan (REBOUND study)
Trial description: This study is an observational, multi-center, with both retrospective and prospective cohort phases, and the duration will depend on the time of participant enrolment. The index date (month 0) will be the date on which the participant had initiated the belimumab therapy. Data will be collected from 12 months prior to index date (pre-index period) and up to 3 years. The primary purpose of the study is to estimate, among adult Taiwanese Lupus Nephritis (LN) participants initiating belimumab and treated for at least three months. Total study treatment duration will be of 24 months with 30 days of follow-up period.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Proportion of participants on Belimumab treatment with preserved renal function defined using mPERR (modified Primary Efficacy Renal Response)

Timeframe: At index date (M0), month 3 (M3), month 6 (M6), month 12 (M12), month 18 (M18), month 24 (M24).

Secondary outcomes:

Proportion of participants on Belimumab treatment with mCRR (modified complete efficacy renal response)

Timeframe: At index date (M0), M3, M6, M12, M18 and M24

Percent change in Estimated Glomerular Filtration Rate (eGFR)

Timeframe: At index date (M0), M3, M6, M12, M18 and M24

Number of Participants with Urine Protein Creatine Ratio (uPCR) and 24-hour proteinuria

Timeframe: At index date (M0), M3, M6, M12, M18 and M24

Change from Baseline in Blood Urine Nitrogen Level

Timeframe: At index date (M0), M3, M6, M12, M18 and M24

Change from Baseline in Serum Creatinine Level

Timeframe: At index date (M0), M3, M6, M12, M18 and M24

Number of Participants with changes in biomarkers parameters. Complement level (C3 and C4). Anti-dsDNA level. Immunoglobulin G level. Serum albumin level. Serum hemoglobin level

Timeframe: At index date (M0), M3, M6, M12, M18 and M24

Incidence Rate per 100 person-year of renal flares

Timeframe: Pre-index period (12 months) and Up to Month 24

Time to renal first flare

Timeframe: Pre-index period (12 months) and Up to Month 24

Duration of Lupus Nephritis related belimumab treatment

Timeframe: Up to Month 25

Incidence Rate per 100 person-year of Hospitalizations or Emergency room (ER) and renal dialysis

Timeframe: Up to Month 25

Interventions:
  • Drug: Belimumab
    • Enrollment:
    60
    Primary completion date:
    2028-28-02
    Observational study model:
    Cohort
    Time perspective:
    Other
    Clinical publications:
    Not applicable
    Medical condition
    Lupus Nephritis
    Product
    belimumab
    Collaborators
    Not applicable
    Study date(s)
    January 2024 to February 2028
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Participants with Lupus Nephritis (LN) participants received National Health Insurance (NHI) reimbursed belimumab for LN treatment after 1st October 2022.
    • Participants who is/was on greater than or equal to (≥) 3 months of reimbursed belimumab treatment.
    • Participants who were on belimumab treatment within 12 months before belimumab reimbursement (1st October 2022).
    • Participants who is currently undergoing chronic renal dialysis.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Participants with Lupus Nephritis (LN) participants received National Health Insurance (NHI) reimbursed belimumab for LN treatment after 1st October 2022.
    • Participants who is/was on greater than or equal to (≥) 3 months of reimbursed belimumab treatment.
    • Participants aged ≥18 years at the time of reimbursed belimumab initial treatment.
    Exclusion criteria:
    • Participants who were on belimumab treatment within 12 months before belimumab reimbursement (1st October 2022).
    • Participants who is currently undergoing chronic renal dialysis.
    • Participation in an ongoing investigational program with interventional therapies outside of routine clinical practice.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Hualien, Taiwan, 970
    Status
    Recruiting
    Contact us
    Location
    GSK Investigational Site
    Taoyuan, Taiwan, 330
    Status
    Recruiting
    Contact us

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Recruiting
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Additional information
    Not applicable
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