Glomerular diseases: Registries and clinical trials

Marva M. Moxey-Mims, Michael F. Flessner, Lawrence Holzman, Frederick Kaskel, John R. Sedor, William E. Smoyer, Aliza M. Thompson, Lynne Yao

Research output: Contribution to journalArticle

6 Scopus citations

Abstract

Nephrology has conducted few high-quality clinical trials, and the trials that have been conducted have not resulted in the approval of new treatments for primary or inflammatory glomerular diseases. There are overarching process issues that affect the conduct of all clinical trials, but there are also some specialty-specific issues. Within nephrology, primary glomerular diseases are rare, making adequate recruitment for meaningful trials difficult. Nephrologists need better ways, beyond histopathology, to phenotype patients with glomerular diseases and stratify the risk for progression to ESRD. Rigorous trial design is needed for the testing of new therapies, where most patients with glomerular diseases are offered the opportunity to enroll in a clinical trial if standard therapies have failed or are lacking. Training programs to develop a core group of kidney specialists with expertise in the design and implementation of clinical trials are also needed. Registries of patients with glomerular disease and observational studies can aid in the ability to determine realistic estimates of disease prevalence and inform trial design through a better understanding of the natural history of disease. Some proposed changes to the Common Rule, the federal regulations governing the ethical conduct of research involving humans, and the emerging use of electronic health records may facilitate the efficiency of initiating multicenter clinical trials. Collaborations among academia, government scientific and regulatory agencies, industry, foundations, and patient advocacy groups can accelerate therapeutic development for these complex diseases.

Original languageEnglish (US)
Pages (from-to)2234-2243
Number of pages10
JournalClinical Journal of the American Society of Nephrology
Volume11
Issue number12
DOIs
StatePublished - Jan 1 2016

Keywords

  • Chronic
  • Clinical trial
  • Cooperative Behavior
  • Electronic Health Records
  • Foundations
  • Glomerular disease
  • Government
  • Humans
  • Kidney
  • Kidney Failure
  • Kidney Glomerulus
  • Nephrology
  • Patient Advocacy
  • Phenotype
  • Prevalence
  • Registries
  • Registries
  • Research
  • Science
  • Specialization

ASJC Scopus subject areas

  • Epidemiology
  • Critical Care and Intensive Care Medicine
  • Nephrology
  • Transplantation

Fingerprint Dive into the research topics of 'Glomerular diseases: Registries and clinical trials'. Together they form a unique fingerprint.

  • Cite this

    Moxey-Mims, M. M., Flessner, M. F., Holzman, L., Kaskel, F., Sedor, J. R., Smoyer, W. E., Thompson, A. M., & Yao, L. (2016). Glomerular diseases: Registries and clinical trials. Clinical Journal of the American Society of Nephrology, 11(12), 2234-2243. https://doi.org/10.2215/CJN.00540116