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Assessment of Kidney Function in Mouse Models of Glomerular Disease
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Glomerular Diseases: Registries and Clinical Trials.

Marva M Moxey-Mims1, Michael F Flessner, Lawrence Holzman

  • 1Due to the number of contributing authors, the affiliations are provided in the Supplemental Material .

Clinical Journal of the American Society of Nephrology : CJASN
|September 28, 2016
PubMed
Summary

Clinical trials in nephrology face challenges, including rare disease recruitment and lack of new treatments for glomerular diseases. Improving trial design, patient phenotyping, and fostering collaborations are crucial for advancing kidney disease therapies.

Keywords:
ChronicCooperative BehaviorElectronic Health RecordsFoundationsGovernmentHumansKidney FailureKidney GlomerulusPatient AdvocacyPhenotypePrevalenceRegistriesResearchScienceSpecializationclinical trialglomerular diseasekidneynephrologyregistries

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Area of Science:

  • Nephrology
  • Clinical Trials
  • Glomerular Diseases

Background:

  • Limited high-quality clinical trials in nephrology have hindered the development of new treatments for glomerular diseases.
  • Rare disease prevalence complicates patient recruitment for statistically significant clinical trials.

Purpose of the Study:

  • To identify challenges and propose solutions for improving clinical trial conduct in nephrology.
  • To enhance the development of novel therapeutic strategies for primary and inflammatory glomerular diseases.

Main Methods:

  • Review of existing clinical trial processes in nephrology.
  • Analysis of specialty-specific issues impacting trial recruitment and design.
  • Consideration of patient phenotyping, risk stratification, and natural history studies.

Main Results:

  • Identified need for improved patient phenotyping beyond histopathology for better risk stratification.
  • Highlighted the necessity for rigorous trial design and specialized training for nephrologists in clinical trial implementation.
  • Emphasized the role of patient registries and observational studies in informing trial design.

Conclusions:

  • Enhanced collaboration among stakeholders, including academia, industry, and patient groups, is essential.
  • Proposed regulatory changes and electronic health record utilization may streamline multicenter trial initiation.
  • Addressing recruitment and design challenges is critical for accelerating therapeutic advancements in glomerular diseases.