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Related Concept Videos

Nephrotic Syndrome II : Assessment and Medical Management01:26

Nephrotic Syndrome II : Assessment and Medical Management

IntroductionNephrotic syndrome is a kidney disorder marked by excessive protein loss in the urine, leading to various systemic complications. This condition often results from damage to the glomeruli—the kidney's filtering units—causing proteinuria, low blood protein levels, and fluid retention. Understanding the assessment, diagnosis, and management of nephrotic syndrome is essential for effective treatment and prevention of further kidney damage.AssessmentPatient History: Document any history...
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The glomerular filtration rate (GFR) is a critical indicator of kidney health, reflecting how well the kidneys filter blood. Changes in GFR can signal potential kidney impairment, necessitating accurate measurement methods to monitor kidney function effectively.Various molecules can serve as markers for GFR measurement, with the ideal marker meeting several specific criteria. It must freely filter at the glomerulus, avoid reabsorption or secretion by the renal tubules, remain unmetabolized, not...
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Renal function tests are crucial for assessing kidney health, monitoring disease progression, and evaluating the kidneys' efficiency in waste elimination, fluid balance, and electrolyte regulation. These tests offer critical insights into kidney function, even though routine measurements may appear normal until there is a significant decline in the glomerular filtration rate or GFR. Typically, signs of kidney impairment only become evident when the GFR falls to about 50% of its normal level.
Diabetic Nephropathy01:28

Diabetic Nephropathy

Definition Diabetic nephropathy is a chronic kidney complication that results from prolonged hyperglycemia.Prevalence It is the most common cause of chronic kidney disease (CKD) and end-stage renal disease (ESRD) worldwide, affecting up to half of individuals with diabetes.Pathophysiology • Sustained hyperglycemia triggers multiple hemodynamic and metabolic changes in the kidney. • Early in the disease, increased renal blood flow and glomerular hyperfiltration occur due to afferent arteriolar...
Drug Dosing in Renal Diseases: Estimation of Glomerular Filtration Rate Based on Serum Creatinine Concentration01:28

Drug Dosing in Renal Diseases: Estimation of Glomerular Filtration Rate Based on Serum Creatinine Concentration

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Related Experiment Video

Updated: May 24, 2026

Proteomic Profile of EPS-Urine through FASP Digestion and Data-Independent Analysis
14:48

Proteomic Profile of EPS-Urine through FASP Digestion and Data-Independent Analysis

Published on: May 8, 2021

Proteinuria as a surrogate end point--more data are needed.

Aliza Thompson1

  • 1Division of Cardiovascular and Renal Products, Office of New Drugs, Center for Drug Evaluation and Research, FDA, White Oak Campus, Silver Spring, MD 20993, USA. aliza.thompson@fda.hhs.gov

Nature Reviews. Nephrology
|March 7, 2012
PubMed
Summary

Proteinuria can serve as a surrogate endpoint in drug development for kidney outcomes. Accelerated approval may be possible if post-market studies confirm benefits on renal outcomes.

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Last Updated: May 24, 2026

Proteomic Profile of EPS-Urine through FASP Digestion and Data-Independent Analysis
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Published on: May 6, 2018

Area of Science:

  • Nephrology
  • Pharmacology
  • Clinical Trial Design

Background:

  • Surrogate endpoints can expedite drug development by showing effects faster and in smaller studies.
  • Proteinuria is a proposed surrogate endpoint for renal outcomes, but regulatory acceptance by the FDA is limited.
  • Increased proteinuria is an early indicator of kidney disease and predicts progression.

Approach:

  • Evaluating the utility of proteinuria as a surrogate endpoint for drug development.
  • Assessing the conditions under which proteinuria effects might support accelerated drug approval.
  • Highlighting the necessity of post-approval studies to confirm clinical benefits.

Key Points:

  • Proteinuria is an early marker for kidney disease progression.
  • The predictive value of proteinuria reduction for actual renal outcomes is not fully established.
  • Regulatory agencies like the FDA have historically been cautious about accepting proteinuria as sole evidence of efficacy.

Conclusions:

  • Proteinuria reduction may be a reasonable basis for accelerated drug approval under specific circumstances.
  • Conditional approval requires post-market trials to validate the drug's benefit on clinical renal outcomes.
  • This approach balances faster access to potentially beneficial drugs with the need for definitive evidence of effectiveness.