Last updated: 02/19/2025 11:20:13

Evaluating Lupus Nephritis (LN) Remission among Participants Initiating Belimumab in a Real-World Setting

GSK study ID
222163
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Will be recruiting
Will be recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Evaluating Renal Remission among Patients with Lupus Nephritis Initiating Belimumab in a Real-World Setting
Trial description: This study aims to explore how participants treated with belimumab in a real-world setting compared to those treated with other standard of care treatments (SOC). This study will evaluate the effectiveness of belimumab, with respect to complete renal response and time to renal flare, among participants with LN in comparison with other SOC treatments in a real-world setting.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Percentage of participants with complete renal response

Timeframe: Up to 1-year post-treatment initiation

Secondary outcomes:

Time to renal flare

Timeframe: Up to 1-year post-treatment initiation

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2025-08-04
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Lupus Nephritis
Product
belimumab
Collaborators
Not applicable
Study date(s)
February 2025 to April 2025
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Diagnosis of Systemic Lupus Erythematosus (SLE) on greater than equal to (>=1) inpatient claim, or on >=2 outpatient claims separated by >=60 days
  • To identify participants with LN: >=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 renal biopsy test
  • Greater than or equals to 1 claim for diagnosis of drug-induced lupus or central nervous system lupus any time before the index date.
  • Claim for, B cell targeted therapy, or any other biologic during the 12 month Baseline period.
Inclusion and exclusion criteria
Inclusion criteria:
  • Diagnosis of Systemic Lupus Erythematosus (SLE) on greater than equal to (>=1) inpatient claim, or on >=2 outpatient claims separated by >=60 days
  • To identify participants with LN: >=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 renal biopsy test
  • At least one claim for treatment for LN, after 01 January 2020, with a diagnosis of SLE at any time prior, and an indicator of LN in the 12 month Baseline period.
  • Treatment for LN will be defined based on the earliest occurrence of one of the indicators.
  • The first indicator of treatment for LN will be defined as the index date.
  • Age >= 18 years on the index date.
  • 12 months of continuous enrollment before the index date.
  • Greater than or equals to 1 measurement for both Urine Protein to Creatinine Ratio (UPCR) and Estimated Glomerular Filtration Rate (eGFR) in the Baseline period and in the observation period.
Exclusion criteria:
  • Greater than or equals to 1 claim for diagnosis of drug-induced lupus or central nervous system lupus any time before the index date.
  • Claim for, B cell targeted therapy, or any other biologic during the 12 month Baseline period.
  • Greater than or equals to 1 claim for dialysis or kidney transplant during the 12 month Baseline period.
  • Greater than or equals to 1 claim for 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
Will be 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

Not applicable
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