Lupus Nephritis Clinical Trials, Lupus Nephritis: Diagnosis and Management, Glomerulonephritis: Caus

Описание: A 32-year-old woman with lupus nephritis at an altitude clinic, stable kidney function, and ongoing immunosuppression, recently recovered from a respiratory infection, is considered for a comparative-effectiveness research study. What key aspects of her clinical presentation and background should inform your approach to trial recruitment and endpoint selection? How can study design be optimized to ensure findings remain widely applicable to diverse patient populations?

VIDEO INFO
Category: Lupus Nephritis Clinical Trials, Lupus Nephritis: Diagnosis and Management, Glomerulonephritis: Causes, Diagnosis, and Management, Nephrology: Kidney Disease Diagnosis and Management
Difficulty: Moderate - Intermediate level - Requires solid foundational knowledge
Question Type: Epidemiology
Case Type: Routine Visit - Standard clinical encounter in outpatient setting

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QUESTION
A 32-year-old woman with systemic lupus erythematosus and a biopsy 6 months ago showing ISN/RPS class IV-G (active/chronic) attends a routine nephrology-rheumatology visit to discuss participation in a pragmatic comparative-effectiveness study. She lives at altitude and recently recovered from an upper-respiratory infection. She is not pregnant. Current medicines: hydroxychloroquine 200 mg twice daily, mycophenolate mofetil 1,000 mg twice daily, prednisone 10 mg daily, and calcium/vitamin D....

OPTIONS
A. Consecutive adults at community and academic sites; recent biopsy-confirmed III/IV/V; central randomization; blinded 12-month endpoint (UPCR =0.5 g/g, stable eGFR) with adjudication; ITT with class/proteinuria stratification.
B. Recruit tertiary-center referrals with UPCR =2.0 g/g and recent hospitalizations only; rely on unadjudicated site-reported outcomes to minimize costs, accelerate timelines, and accept heterogeneous adherence patterns explicitly.
C. Use an online opt-in registry with self-reported dipstick protein at 6 months and accept kidney biopsies up to 5 years old to broaden eligibility, reduce screening, and waive remote record verification.
D. Restrict to new class IV cases on a repeat biopsy within 30 days and exclude community sites; define success as 50% proteinuria reduction at 24 weeks without eGFR requirements or safety lab thresholds.

CORRECT ANSWER
A. Consecutive adults at community and academic sites; recent biopsy-confirmed III/IV/V; central randomization; blinded 12-month endpoint (UPCR =0.5 g/g, stable eGFR) with adjudication; ITT with class/proteinuria stratification.

EXPLANATION
A pragmatic LN trial should enhance external validity by enrolling consecutive adults across community and academic sites with recent biopsy-confirmed class III/IV/V disease, while preserving core trial quality through centralized randomization, blinded adjudication of a clinically meaningful endpoint (e.g., UPCR =0.5 g/g with stable eGFR at 12 months), and intention-to-treat analysis with prespecified stratification by class and proteinuria....


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