Clinical trial NCT06527872: Study to Assess Real-world Effectiveness of Belimumab for Treatment of Adults With LN
Official title: The Evaluation Of Use of Belimumab in Routine Care SEttings in Lupus Nephritis (LN): the OBSErve-LN Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lupus Nephritis
Keywords: Belimumab
Lupus nephritis
OBSErve-LN
Renal function
Real world data
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2024-07-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include participants with lupus nephritis who initiated belimumab prescribed as per local label alongside standard therapy/ies under routine care conditions in the countries of interest.

Brief summary: The purpose of the OBSErve-LN study is to assess the real-world use and effectiveness of belimumab in routine practice for the treatment of adults with active LN in multiple countries of interest. This study aims to provide the first long-term (up to 5 years) assessment of renal function preservation in belimumab treated participants.


Eligibility criteria: Inclusion Criteria:

* Participants to provide a signed informed consent at the time of enrollment per protocol,
* Male or female aged 18 or over at initiation of belimumab,
* Participants received belimumab for the treatment of active LN prescribed as per local label in combination with standard immunosuppressive therapy/ies at initiation of belimumab,
* Participants initiated belimumab 6 to 24 months prior to study enrollment,
* Accessibility of medical records starting at belimumab initiation (including accessibility of medical records for the prior 12 months and confirmatory biopsy within the prior 24 months from belimumab initiation),
* Biopsy-confirmed diagnosis of active LN in the two-years prior to the initiation of belimumab

  * Class III (focal LN) with or without Class V (membranous LN),
  * Class IV (diffuse LN) with or without Class V,
  * Class V.

Exclusion Criteria:

* Participants receiving renal replacement therapy at initiation of belimumab,
* Participant is concomitantly receiving another biologic at initiation of belimumab,
* Participants in a clinical trial during the observation period (with the exception of allowing participation in other non-interventional studies),
* Participant is pregnant at the initiation of belimumab,
* Participant with a kidney transplant at the initiation of belimumab,
* Participants will be excluded from the study if they are planning to become pregnant or are pregnant at study enrollment.

Primary outcomes:
measure: Number of participants maintaining renal function (less than equal to [<=]30 percentage [%] decline in estimated glomerular filtration rate [eGFR] from the initiation of belimumab) and not requiring renal replacement therapy
timeFrame: At Month 24
Secondary outcomes:
measure: Number of participants achieving Modified Partial Renal Response (<=20% decline eGFR and <=0.7 Urine Protein-Creatinine Ratio [uPCR]) and Modified Complete Renal Response (<=10% decline eGFR and <=0.5 uPCR)
timeFrame: At Months 24, and 60
measure: Number of participants maintaining renal function (<=30% decline in eGFR from the initiation of belimumab) and not requiring renal replacement therapy (in those that remain adherent to belimumab) at Month 24
timeFrame: At Month 24
measure: Change in the daily dose of steroid (in milligrams per day) from the initiation of belimumab
timeFrame: Baseline (Day 1) to Month 60
measure: Estimated Glomerular Filtration Rate (eGFR) slope over time
timeFrame: Up to Month 60
measure: Time to achieving eGFR 30% and 40% reduction
timeFrame: Up to Month 60
measure: Time to initiating renal replacement therapy
timeFrame: Up to Month 60
measure: Number of participants maintaining renal function (<=30% decline in eGFR from the initiation of belimumab) and not requiring renal replacement therapy
timeFrame: At Month 60
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
Study officials:
References: