Lupus & antiphospholipid syndrome
Measurement of kidney disease in a novel multidomain treatment response measure for SLE clinical trials
Authors' conclusion
Lupus-related kidney disease response within the TRM-SLE will be measured by proteinuria improvement without significant eGFR worsening. Clinically meaningful thresholds for entry and improvement were defined, allowing the assessment of response in patients with active kidney disease in general SLE RCTs.
Study context
- Population
- International working group of clinicians and patient representatives defining treatment response for lupus-related kidney disease in SLE randomised controlled trials (RCTs)eight clinicians and four patient representatives · clinicians eight · patient representatives four
- Outcome
- Definition of the 'nephropathy' domain for Treatment Response Measure for SLE (TRM-SLE)
Methodological detailssystematic literature review (SLR), Nominal group technique, international working group
- Systematic literature review (SLR)
- Nominal group technique
- International working group
Recommendations
As reported in the abstract
Consensus
100%
Further findings
Candidate response measures and SLR
- Unique nominations
- 30
- Candidate response measures shortlisted
- four
- Articles screened
- 8012
- Relevant papers included
- 50
Consensus response definition and thresholds
- Entry threshold
- Urine protein-creatinine ratio (UPCR) >1 g/g
- Clinically meaningful response (CMR) threshold
- UPCR improvement >50% from baseline and UPCR <1 g/g if baseline UPCR <3 g/g or <3 g/g if baseline UPCR ≥3 g/g
- Complete response (CR) threshold
- UPCR ≤0.2 g/g
- Response based on proteinuria improvement, assessed via UPCR on a 24-hour or first morning void collection
- Responders also require estimated glomerular filtration rate (eGFR) within 80% of baseline
Original publication
Measurement of kidney disease in a novel multidomain treatment response measure for SLE clinical trials. Lupus Sci Med. Published 9 November 2026. doi:10.
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