Study to Assess Real-world Effectiveness of Belimumab for Treatment of Adults With LN

NCT06527872 | Recruiting

• 1 other identifier: 216147
• Study Type: observational
• Target: 300
• Locations: 2 countries
• Sites: 5

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.

Conditions

Lupus Nephritis

Keywords

Belimumab; Lupus nephritis; OBSErve-LN; Renal function; Real world data

Outcome Measures

Primary Outcomes (1)

• 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

  Renal replacement therapy will involve participants requiring dialysis, kidney transplant, or those in end-stage kidney disease.

  At Month 24

Secondary Outcomes (7)

• 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

• 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

Study Arms (1)

All Participants cohort

Participants with active LN who initiated belimumab as per local label alongside standard therapy/ies under routine care conditions.

Other: None (Observational study)

Interventions

None (Observational study) OTHER

Not Applicable since Observational Study

Also known as: Observational Study

All Participants cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (5)

GSK Investigational Site

Baltimore, Maryland, 21287, United States

RECRUITING

GSK Investigational Site

Charlotte, North Carolina, 28207, United States

RECRUITING

GSK Investigational Site

Columbus, Ohio, 43201, United States

RECRUITING

GSK Investigational Site

Hixson, Tennessee, 37343-7908, United States

RECRUITING

GSK Investigational Site

Fukuoka, 807-8556, Japan

RECRUITING

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Observation

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 30, 2024
• Study Start: October 4, 2024
• Primary Completion (Estimated): March 29, 2029
• Study Completion (Estimated): March 29, 2029
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); JP (1)