Special Section: GFR Decline as an End Point for Clinical Trials in CKDEditorialGFR Decline as an End Point in Trials of CKD: A Viewpoint From the FDA
Section snippets
Acknowledgements
The authors thank Ellis Unger and Robert Temple from the FDA’s Center for Drug Evaluation and Research for their valuable comments on this editorial.
Support: None.
Financial Disclosure: The authors declare that they have no relevant financial interests.
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Trajectories of glomerular filtration rate and progression to end stage kidney disease after kidney transplantation
2021, Kidney InternationalCitation Excerpt :This finding reinforces the potential of trajectory-based patient assessment at an early stage after transplantation to predict long-term eGFR course and ESRD in clinical trials. Indeed, in CKD clinical trials, a change in kidney function is the only alternative outcome to death or allograft failure that has been proposed as a meaningful surrogate end point by the Food and Drug Administration.27 Consequently, to make trajectory-based monitoring of patients feasible in contemporary transplant practice, we developed an easy-to-use online interface that allows clinicians to predict the personalized likely future kidney function trajectory of any given patient and the related risk of future allograft failure (https://transplant-prediction-system.shinyapps.io/personalized_eGFR_trajectories_prediction/).
Addressing the Need for Clinical Trial End Points in Autosomal Dominant Polycystic Kidney Disease: A Report From the Polycystic Kidney Disease Outcomes Consortium (PKDOC)
2019, American Journal of Kidney DiseasesCitation Excerpt :It is perhaps easiest to define acceptable end points for approval in patients who already have reduced GFRs. Treatment effects on the irreversible loss of kidney function, typically defined as a loss of function of a specified magnitude, reaching a GFR < 15 mL/min/1.73 m2, or initiation of maintenance dialysis therapy or receipt of a kidney transplant, have long been accepted as a basis for traditional approval of drugs to treat chronic kidney diseases.26 For uncommon, slowly progressive kidney diseases with a high likelihood of progression to end-stage kidney disease, treatment effects on the rate of decline in GFR (eg, GFR slope) are also acceptable provided that data indicate that the benefit continues to accrue across the various stages of disease and over time, thus indicating that the treatment will have a meaningful impact on progression to end-stage kidney disease.
Using All Longitudinal Data to Define Time to Specified Percentages of Estimated GFR Decline: A Simulation Study
2019, American Journal of Kidney Diseases