Lupus Nephritis
Conditions
Keywords
Belimumab, Lupus nephritis, OBSErve-LN, Renal function, Real world data
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.
Detailed description
This is a Phase 4 study and will involve both prospective and retrospective data collection from participants.
Interventions
OTHERNone (Observational study)
Not Applicable since Observational Study
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 in any formulation (subcutaneous or intravenous) 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 at any time prior to belimumab initiation), * Biopsy-confirmed LN diagnosis at any time prior to belimumab initiation for treatment of LN * 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 (i.e., dialysis, kidney transplant, or those in end-stage kidney disease) at initiation of belimumab, * Participant is concomitantly receiving another SLE targeted monoclonal antibody (MAb), or a MAb expected to compromise immune responses, 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | At Month 24 | Renal replacement therapy will involve participants requiring dialysis, kidney transplant, or those in end-stage kidney disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving Modified Partial Renal Response (<=20% Decline in eGFR and <=0.7 Urine Protein-Creatinine Ratio [uPCR]) and Modified Complete Renal Response (<=10% Decline in eGFR and <=0.5 uPCR) | At Months 24 and 60 | — |
| 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 | At Month 24 | Renal replacement therapy will involve participants requiring dialysis, kidney transplant, or those in end-stage kidney disease. |
| Change in the Daily Dose of Steroid (in milligrams per day) from the Initiation of Belimumab | Baseline (Day 1) to Month 60 | — |
| Estimated Glomerular Filtration Rate (eGFR) Slope over Time | Up to Month 60 | — |
| Time to Achieving eGFR 30% and 40% Reduction | Up to Month 60 | — |
| Time to Initiating Renal Replacement Therapy | Up to Month 60 | Renal replacement therapy will involve participants requiring dialysis, kidney transplant, or those in end-stage kidney disease. |
| Number of Participants Maintaining Renal Function (<=30% Decline in eGFR from the Initiation of Belimumab) and Not Requiring Renal Replacement Therapy | At Month 60 | Renal replacement therapy will involve participants requiring dialysis, kidney transplant, or those in end-stage kidney disease. |
Countries
France, Italy, Japan, United States
Contacts
CONTACTUS GSK Clinical Trials Call Center
CONTACTEU GSK Clinical Trials Call Center
STUDY_DIRECTORGSK Clinical Trials
GlaxoSmithKline
Outcome results
None listed