Last updated: 03/26/2024 11:20:10
PGx_218044_PHNA_PGx analysis of APOL1 genetic variants for participants with SLE in four Phase III belimumab clinical studies
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: 218044 Analysis of the effect of Apolipoprotein L1 risk variants on treatment response to belimumab in systemic lupus erythematosus (SLE) patients of self-reported Black race who participated in clinical trial BEL110752/BLISS52/C1057, BEL110751/BLISS-76/C1056 BEL112341, or BEL115471/EMBRACE
Trial description: This study assesses the effect of APOL1 risk variants on response to belimumab in self-reported black participants with Systemic Lupus Erythematosus in studies BEL110751, BEL110752, BEL112341, BEL115471.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Change from baseline in protein:creatinine levels
Timeframe: 52 weeks
Proportion of subjects who develop nephritis
Timeframe: 52 weeks
Change from baseline in estimated glomerular filtration rate (eGFR)
Timeframe: 52 weeks
Secondary outcomes:
Systemic Lupus Responder Index (SRI4) response
Timeframe: 52 weeks
Time to first severe flare
Timeframe: 52 weeks
Change from baseline in Systemic Lupus International Collaborating Clinics (SLICC) damage score
Timeframe: 52 weeks
Change from baseline in Physician’s Global Assessment (PGA) score
Timeframe: 52 weeks
Change from baseline in complement C3 levels
Timeframe: 52 weeks
Change from baseline in complement C4 levels
Timeframe: 52 weeks
Change from baseline in anti-double stranded DNA levels
Timeframe: 52 weeks
Interventions:
Enrollment:
0
Primary completion date:
2021-10-12
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
October 2021 to December 2021
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- In the ITT populations of BEL110751, BEL110752, BEL112341, BEL115471 AND
- Received at least one dose of placebo or belimumab AND
- Not in the ITT populations of BEL110751, BEL110752, BEL112341, BEL115471 OR
- Did not receive at least one dose of placebo or belimumab OR
Inclusion and exclusion criteria
Inclusion criteria:
- In the ITT populations of BEL110751, BEL110752, BEL112341, BEL115471 AND
- Received at least one dose of placebo or belimumab AND
- Self-reported black race AND
- Provided written informed consent for genetics research, a DNA sample, and were successfully genotyped
Exclusion criteria:
- Not in the ITT populations of BEL110751, BEL110752, BEL112341, BEL115471 OR
- Did not receive at least one dose of placebo or belimumab OR Were not of self-reported black race OR
- Did not provide written informed consent for genetics research, a DNA sample, or were not successfully genotyped
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2021-10-12
Actual study completion date
2021-10-12
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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