Last updated: 11/04/2024 08:20:07
Study to assess real-world effectiveness of belimumab for treatment of adults with LNOBSErve-LN
GSK study ID
216147
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title: The evaluation Of use of Belimumab in routine care SEttings in Lupus Nephritis (LN): the OBSErve-LN Study
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
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:
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
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
Change in the daily dose of steroid (in milligrams per day) from the initiation of belimumab
Timeframe: Baseline (Day 1) to Month 60
Estimated Glomerular Filtration Rate (eGFR) slope over time
Timeframe: Up to Month 60
Time to achieving eGFR 30% and 40% reduction
Timeframe: Up to Month 60
Time to initiating renal replacement therapy
Timeframe: Up to Month 60
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
Interventions:
Enrollment:
300
Primary completion date:
2029-29-03
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Lupus Nephritis
Product
belimumab
Collaborators
Not applicable
Study date(s)
October 2024 to March 2029
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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 receiving renal replacement therapy at initiation of belimumab,
- Participant is concomitantly receiving another biologic at initiation of belimumab,
Inclusion and exclusion 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 o Class III (focal LN) with or without Class V (membranous LN), o Class IV (diffuse LN) with or without Class V, o 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.
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
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
Additional information
Not applicable
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