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Hormonal Regulation

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The renin-aldosterone system is an endocrine system which guides the renal absorption of water and electrolytes, thus managing blood pressure and osmoregulation. Activation of the system begins in the kidneys with a small cluster of cells adjacent to the afferent and efferent blood vessels of the renal corpuscle. As the nephrons are filtering blood, juxtaglomerular cells monitor blood pressure. If they detect a decrease in pressure, they release the hormone renin into the bloodstream.
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The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
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Low-Grade Proteinuria in Lupus Nephritis: Why "Mild" Is Often Misleading.

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Related Experiment Video

Updated: Jun 4, 2025

Analyses of Proteinuria, Renal Infiltration of Leukocytes, and Renal Deposition of Proteins in Lupus-prone MRL/lpr Mice
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Lupus nephritis randomised controlled trials: evidence gaps and under-represented groups.

Alberto Nordmann-Gomes1,2, Gabriel Cojuc-Konigsberg3, Adriana Hernández-Andrade2

  • 1School of Medicine, Universidad Panamericana, Mexico City, Mexico.

Lupus Science & Medicine
|December 20, 2024
PubMed
Summary

This review of lupus nephritis clinical trials highlights under-representation of diverse populations and inconsistent study designs. More inclusive research is needed for lupus nephritis therapies.

Keywords:
Clinical TrialLupus NephritisOutcome Assessment, Health CarePatient Reported Outcome MeasuresSystemic Lupus Erythematosus

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Area of Science:

  • Nephrology
  • Rheumatology
  • Clinical Pharmacology

Background:

  • Lupus nephritis (LN) management relies on evidence from randomized clinical trials (RCTs).
  • Assessing the generalizability and identifying evidence gaps in current LN pharmacological therapy research is crucial.

Purpose of the Study:

  • To conduct a scoping review of RCTs on pharmacological therapies for initial lupus nephritis management.
  • To analyze study design, participant populations, and outcome definitions to evaluate generalizability and identify research gaps.

Main Methods:

  • Systematic evaluation of RCTs for initial LN therapy (2000-2024).
  • Extracted data on study design, participant criteria, outcomes, and clinical characteristics.
  • Classified interventions into guideline-recommended (e.g., cyclophosphamide, mycophenolic acid analogues) and other regimens.
  • Assessed study robustness using the Fragility Index (FI).

Main Results:

  • 124 intervention arms from 61 RCTs involving 7058 participants were analyzed.
  • Guideline-recommended therapies (MPAA, NIH-CYC, triple-drug) comprised 63.7% of interventions.
  • Multinational studies were common for triple-drug therapies but rare for NIH-CYC and tacrolimus.
  • Limited follow-up (≥24 months) in most RCTs (14.8%).
  • Under-representation of Black/other races and specific global regions was noted.
  • Serious adverse events and patient-reported outcomes were infrequently reported.
  • Outcome definitions and assessment intervals for response were variable.
  • Low robustness (FI 1-3) was observed for RCTs of double-drug guideline-recommended therapies.

Conclusions:

  • There is a need for broader inclusion of under-represented populations in LN clinical trials.
  • Homogenization of study design and outcome reporting is essential for improved generalizability.
  • Further research is warranted to explore novel interventions and treatment comparisons in areas with limited evidence.