Last updated: 05/21/2026 16:30:19
Comparison of Belimumab Plus Standard of Care (SOC) Versus SOC Alone in Lupus Nephritis (LN)
GSK study ID
300881
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Planned
Planned
Trial overview
Official title: Comparative Effectiveness of Belimumab Plus Standard of Care Vs Standard of Care Alone in Lupus Nephritis
Trial description: The study aims to compare the real-world effectiveness of belimumab plus standard of care (SOC) versus SOC alone in participants with lupus nephritis (LN). Data from healthcare administrative claims will be utilized for this purpose. Participants initiating belimumab will be included in the belimumab cohort. The index date for belimumab cohort will be defined as the date of belimumab initiation among participants with LN receiving SOC. At each belimumab initiation, a risk set of participants will be formed at the corresponding time since initiation of SOC for LN, from which participants will be randomly selected to be included in the SOC cohort. The index date for SOC cohort will be defined as the time point corresponding to the same duration since SOC initiation as the belimumab initiation event that generated the risk set.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Time to Achieving Modified Complete Renal Response (mCRR) Sustained Through Week 52
Timeframe: From index date up to Week 52
Secondary outcomes:
Time to First Renal Flare
Timeframe: From index date up to approximately 54 months
Time to Achieving mCRR Sustained Through Week 52 Based on a Classic Definition
Timeframe: From index date up to Week 52
Interventions:
Not applicable
Enrollment:
Not applicable
Observational study model:
Cohort
Primary completion date:
2026-08-07
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Lupus Nephritis
Product
Not applicable
Collaborators
Not applicable
Study date(s)
May 2026 to July 2026
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Inclusion criteria as of study entry:
- Diagnosis of systemic lupus erythematosus (SLE) any time prior to the study entry date, based on:
- Exclusion criteria as of study entry:
- >=1 claim for belimumab and obinutuzumab (i.e., biologics indicated for LN), anifrolumab (a biologic indicated for SLE), or rituximab (a biologic commonly used off-label for SLE and LN) during the washout period (i.e., the 6-month period prior to SOC initiation)
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosis of systemic lupus erythematosus (SLE) any time prior to the study entry date, based on:
- Greater than or equal to (>=) 1 inpatient (IP) claim, or
- >=1 indicator of LN any time prior to the study entry date defined as:
- >=1 claim with LN diagnosis code or
- >=2 claims with renal diagnosis codes on distinct dates, or
- >=2 claims for nephrologist encounters on distinct dates, or
- >=1 claim for treatment with SOC as induction therapy after the first observed indicator for LN
- >=6 months of continuous enrolment before the study entry date (washout period) Inclusion criteria as of index date:
- Criterion for belimumab cohort only: >=1 claim for treatment with belimumab on or after the SOC initiation date
- Index date on or after December 17, 2020 (belimumab approval date)
- >=1 claim for treatment with SOC within the 3 months prior to or on the index date
- Age >=18 years on the index date
- >=12 months of continuous enrolment before the index date (baseline period)
- >=1 measurement for both urine protein-to-creatinine ratio (UPCR) and estimated glomerular filtration rate (eGFR) in the baseline and observation periods
- This criterion is required to assess the study outcomes
Inclusion criteria as of study entry:
>=2 outpatient (OP) / emergency room (ER) claims separated by >=60 days
>=1 claim for renal biopsy test any time before the study entry date in any care setting
The first observed claim for SOC treatment following an indicator for LN will be defined as the study entry date
The index date is defined as the first such observed claim for belimumab
This criterion helps ensure that participants have not discontinued SOC treatment prior to the index date
Exclusion criteria:
- >=1 claim for belimumab and obinutuzumab (i.e., biologics indicated for LN), anifrolumab (a biologic indicated for SLE), or rituximab (a biologic commonly used off-label for SLE and LN) during the washout period (i.e., the 6-month period prior to SOC initiation)
- >=1 claim for CNI (voclosporin, tacrolimus, or cyclosporin) during the washout period Exclusion criteria as of index date:
- >=2 claims for diagnosis of drug-induced lupus on distinct dates, any time before the index date
- >=1 claim for belimumab and obinutuzumab, anifrolumab, or rituximab during the baseline period
- >=1 claim for CNI during the baseline period
- >=1 claim for dialysis or kidney transplant any time before the index date
- >=1 measurement of eGFR less than <15 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2) any time before the index date
- >=1 claim for diagnosis of end-stage renal disease (ESRD) any time before the index date
- >=1 claim for diagnosis of polycystic kidney disease or kidney cancer any time before the index date
- >=1 claim for hereditary nephropathy any time before the index date
Exclusion criteria as of study entry:
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Planned
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
Not applicable
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