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Rethinking clinical endpoints in kidney transplant trials
- Source :
- Current opinion in organ transplantation. 25(1)
- Publication Year :
- 2019
-
Abstract
- Purpose of review Clinical trials testing novel kidney transplant therapies are challenged by low rates of long-term clinical outcomes such as death and graft loss. Herein, we critically review traditional and more recent strategies to expedite new therapies by minimizing sample size and follow-up duration using surrogates (alone or in the context of composite endpoints), or using different clinical endpoints. Recent findings Multiple surrogate endpoints are increasingly important for organ transplantation trial design: glomerular filtration rate slope, albuminuria, donor-specific alloantibodies, and histological score at graft protocol biopsies. However, surrogate endpoint use is limited by bias when data are missing. Hierarchical multiple primary endpoints - that are successfully used in other settings and frequently utilize surrogate endpoints - have not yet been integrated into kidney transplant studies. New clinical endpoints, focusing on treatment safety and patient quality of life have been recently standardized and should be reported regardless of the primary endpoint of any randomized controlled trial. Summary Defining surrogates, standards for outcome reporting, and statistical strategies to appropriately analyze them are critical to effectively testing and implementing novel therapeutic strategies to improve long-term clinical outcomes in kidney transplantation.
- Subjects :
- medicine.medical_specialty
Context (language use)
030230 surgery
Organ transplantation
law.invention
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
law
Clinical endpoint
Immunology and Allergy
Medicine
Humans
Intensive care medicine
Kidney transplantation
Transplantation
business.industry
Surrogate endpoint
medicine.disease
Kidney Transplantation
Clinical trial
Albuminuria
Quality of Life
030211 gastroenterology & hepatology
medicine.symptom
business
Biomarkers
Subjects
Details
- ISSN :
- 15317013
- Volume :
- 25
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Current opinion in organ transplantation
- Accession number :
- edsair.doi.dedup.....7f9927043d0e6032ba605b576a7d2864