Last updated: 10/27/2025 18:40:10
Kidney Impairment in Participants With Systemic Lupus Erythematosus on Belimumab Versus Standard of Care
GSK study ID
217533
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Evaluating Decline in Kidney Function in a Real-World Population of Patients with Systemic Lupus Erythematosus Treated with Belimumab Versus Standard of Care
Trial description: This study will evaluate the impact of belimumab (as compared to standard of care [SOC]) on decline in kidney function among adult participants with SLE in the United States (US). The index date will be the date of the first prescription for belimumab or SOC. The first month after the index date will serve as the washout period for participants.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Percent change in estimated glomerular filtration rate (eGFR) measurement from Baseline to observation period
Timeframe: Baseline (12 months before index date) to observation period (11 months after washout period)
Secondary outcomes:
Time to worsened kidney impairment
Timeframe: Baseline (12 months before index date) to observation period (11 months after washout period)
Time to initiation of Lupus nephritis (LN) induction therapy
Timeframe: Up to observation period (11 months after washout period)
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2025-06-10
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Lupus Nephritis
Product
belimumab
Collaborators
Not applicable
Study date(s)
December 2023 to October 2025
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- For the belimumab cohort, initiation of a prescription for Intravenous (IV) or Subcutaneous (SC) belimumab between 01-Jan-2017 and 31-Mar-2023 (defines the index date).
- For the SOC cohort without prior belimumab use, the earliest occurrence of any of the following three clinical activities between 01-Jan-2017 and 31-Mar-2023 will qualify for inclusion and define the index date. For those with prior belimumab use, the earliest of any of these activities on or after the discontinuation of belimumab will define the index date:
- For the belimumab cohort, those on belimumab monotherapy (that is [i.e.], exclude those with no prescriptions for any SLE therapy, including immunosuppressants, steroids, or antimalarials in the past 6 months)
- Diagnosis of drug-induced lupus any time before the index date
Inclusion and exclusion criteria
Inclusion criteria:
- For the belimumab cohort, initiation of a prescription for Intravenous (IV) or Subcutaneous (SC) belimumab between 01-Jan-2017 and 31-Mar-2023 (defines the index date).
- For the SOC cohort without prior belimumab use, the earliest occurrence of any of the following three clinical activities between 01-Jan-2017 and 31-Mar-2023 will qualify for inclusion and define the index date. For those with prior belimumab use, the earliest of any of these activities on or after the discontinuation of belimumab will define the index date:
- Initiation of an immunosuppressant (either first time use or switching to a new immunosuppressant) for the treatment of systemic lupus erythematosus (SLE)
- Initiation of IV corticosteroids
- Initiation or dose escalation of oral corticosteroids (OCS) to a prednisone-equivalent dosage >=20 milligram per day (mg/day) for participants who never had a dose >=20 mg/day during the Baseline period.
- As OCS may have different dosage forms, doses of different OCS will be converted to equivalent prednisone strengths for the calculation of expected daily dose. These conversions will be based on the potencies and duration of action of the OCS. The conversions for the equivalent dose of each OCS to 7.5 mg of prednisone were extracted from the literature and medical references, and the conversion table.
- Diagnosis of SLE at any time before or on the index date based on
- >=2 outpatient medical records at least 60 days apart, OR
- >=1 inpatient/ Emergency Room (ER) record
- Age >=18 years on the index date
- >=12 months of continuous enrollment before and after the index date
- For the analyses of percent change in eGFR and time to worsened kidney impairment outcome, participants are also required to have at least one eGFR measurement during the Baseline period and during the observation period. In addition, participants in the analysis of percent change in eGFR will be required to not switch treatment cohorts for at least 12 months after the index date.
Exclusion criteria:
- For the belimumab cohort, those on belimumab monotherapy (that is [i.e.], exclude those with no prescriptions for any SLE therapy, including immunosuppressants, steroids, or antimalarials in the past 6 months)
- Diagnosis of drug-induced lupus any time before the index date
- Diagnosis of active central nervous system lupus any time before the index date
- Diagnosis of lupus nephritis (LN) prior to the index date
- Initiation of LN induction therapy prior to the index date
- Prescription for the index therapy within the 12 months preceding the participant’s index date (for those who qualify for more than one treatment cohort, this applies only to the first index date)
- Prescription for anifrolumab during the 12-month baseline period
- Participants with a diagnosis of polycystic kidney disease or kidney cancer
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Study complete
Actual primary completion date
2025-06-10
Actual study completion date
2025-06-10
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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