Largest-Ever CKD Data Compilation May Guide Future Treatments
At a joint scientific workshop, the National Kidney Foundation (NKF), the US Food and Drug Administration, and the European Medicines Agency recently reviewed the results of the largest compilation of data ever collected on chronic kidney disease (CKD).
Researchers anticipate using the data to determine whether surrogate biomarkers, such as albuminuria and glomerular filtration rate (GFR), can be used to predict a treatment’s effect on progression to kidney failure in the early stages of CKD.
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“The work presented over the past 2 days will help move us closer to developing medications to arrest kidney disease in its earliest stages before patients progress to end-stage renal disease and are faced with life-threatening complications and only dialysis or a transplant as options to survive,” said Andrew S. Levey, MD, workshop chair and professor of medicine at Tufts University School of Medicine in Boston, Massachusetts, in an article for the NKF.
A total of 49 studies (N = 44,816) were included in the meta-analysis. Furthermore, GFR slopes were assessed using data from a consortium of international observational cohorts, as well as data on urine protein from 19 cohorts (N = 600,000) and 22 cohorts (N = 1.3 million).
“This extensive meta-analysis of endpoints for chronic kidney disease builds upon previous research which recommended a 30 or 40% decline in GFR as the endpoint for clinical trials in some CKD populations,” said Kerry Willis, PhD, chief scientific officer of the NKF.
However, Dr Willis added, these workshop findings have indicated that these recommended endpoints are less applicable to the clinical development of drugs geared towards patients with earlier stages of kidney disease and for many drugs with possible hemodynamic effects.
Overcoming these obstacles was ultimately the driving force behind the workshop, she said.
—Christina Vogt
Reference:
Change in albuminuria and GFR as end points for clinical trials in early stages of chronic kidney disease. National Kidney Foundation. March 16, 2018. https://www.kidney.org/news/accelerating-new-clinical-trials-and-treatments-kidney-disease. Accessed on March 20, 2018.