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Related Concept Videos

Clinical Trials01:16

Clinical Trials

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Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
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Clinical Trials: Overview01:11

Clinical Trials: Overview

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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Renal Regulation of Acid-Base Balance01:29

Renal Regulation of Acid-Base Balance

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Metabolic reactions in the body produce nonvolatile acids, such as sulfuric acid, which generate an acid load of approximately 1 mEq of H+ per kilogram of body weight daily. Excreting H+ in the urine is essential to balance this acid load.
In the kidneys, cells within the proximal convoluted tubules (PCT) and the collecting ducts secrete hydrogen ions (H+) into the tubular fluid. Specifically, in the PCT, Na+/H+ antiporters secrete H+ while reabsorbing Na+.
However, the intercalated cells in...
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Urinary Tract Calculi II: Pathophysiology and Clinical Manifestations01:26

Urinary Tract Calculi II: Pathophysiology and Clinical Manifestations

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Renal calculi, commonly termed kidney stones, are crystalline solid masses that form in the kidneys but can occur at any point within the urinary system, encompassing the kidneys, ureters, bladder, and urethra.The pathophysiology of renal stones involves several key factors: supersaturation of the urine with stone-forming constituents, changes in urine pH, a decrease in urine volume, and the presence of substances that promote or inhibit stone formation.Supersaturation of Urine: This is the...
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Chronic Kidney Disease II: Clinical Manifestations01:24

Chronic Kidney Disease II: Clinical Manifestations

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Chronic Kidney Disease (CKD) progressively impairs multiple body systems due to the accumulation of uremic toxins, which disrupt cellular functions across various organs.Neurologic symptomsNeurologic symptoms often arise early in CKD, as uremic toxin buildup drives changes in cognitive and motor functions. Patients frequently experience fatigue, headache, confusion, difficulty concentrating, and, in severe cases, seizures. Peripheral neuropathy commonly manifests as burning sensations in the...
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Phase I Oxidative Reactions: Overview01:19

Phase I Oxidative Reactions: Overview

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Phase I biotransformation, or functionalization, is a crucial chemical process that converts drugs and other xenobiotics into more water-soluble forms, facilitating expulsion from the body. It involves oxidative, reductive, and hydrolytic reactions that add or unveil polar functional groups on lipophilic substrates. Key players in phase I reactions are the mixed-function oxidases. Situated in liver cell microsomes, these enzymes predominantly carry out drug metabolism. They require molecular...
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Primary hyperoxaluria type 1-current practice in the siRNA era: an ERA Genes & Kidney Working Group survey.

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Updated: Dec 26, 2025

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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End Points for Clinical Trials in Primary Hyperoxaluria.

Dawn S Milliner1, Tracy L McGregor2, Aliza Thompson3

  • 1Division of Nephrology, Mayo Clinic, Rochester, Minnesota.

Clinical Journal of the American Society of Nephrology : CJASN
|March 14, 2020
PubMed
Summary

Primary hyperoxaluria patients lack approved treatments. Kidney stones, eGFR, urine oxalate, and plasma oxalate are key trial endpoints for evaluating new therapies in clinical studies.

Keywords:
biomarkerschronicclinical trial end pointshyperoxaluriakidneykidney calculikidney stonesliver transplantationoxalateprimaryprimary hyperoxaluria type 1rare kidney diseaseregistriesrenal dialysisrenal insufficiency

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Area of Science:

  • Nephrology
  • Clinical Trial Design
  • Biomarkers

Background:

  • Primary hyperoxaluria (PH) causes progressive kidney damage and failure.
  • Current treatment options are limited, with no FDA-approved therapies.
  • Systemic oxalosis, dialysis, and transplantation are common in advanced PH.

Purpose of the Study:

  • To identify and evaluate clinical outcome and surrogate endpoints for PH clinical trials.
  • To inform the development of new therapeutic strategies for PH.

Main Methods:

  • A workgroup critically examined published literature on clinical outcomes and potential surrogate endpoints.
  • Inclusion of physicians, scientists, patients, industry, and regulators.
  • Analysis focused on kidney stones, eGFR, urine oxalate, and plasma oxalate.

Main Results:

  • Kidney stones, change in estimated glomerular filtration rate (eGFR), urine oxalate, and plasma oxalate identified as strongest candidate endpoints.
  • Urine oxalate is a likely predictor of clinical benefit in early CKD stages.
  • Plasma oxalate is associated with systemic oxalosis risk in advanced CKD stages.

Conclusions:

  • Change in eGFR slope can serve as a clinically meaningful endpoint for traditional approval.
  • Substantial changes in urine oxalate or plasma oxalate may support traditional or accelerated approval, respectively.
  • Further data are needed to facilitate testing of new PH treatments.