ArticleKidney international2017
Improved clinical trial enrollment criterion to identify patients with diabetes at risk of end-stage renal disease.
Article in Kidney international, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
28 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- Impact of random variation in albuminuria and estimated glomerular filtration rate on patient enrolment and duration of clinical trials in nephrology.Diabetes, obesity & metabolism · 2022Trial
- Effects of Selonsertib in Patients with Diabetic Kidney Disease.Journal of the American Society of Nephrology : JASN · 2019Trial
- Soluble tumor necrosis factor receptors in diabetes: risk sensing and receptor-resolved targeting.Endocrine journal · 2026Review
- Diabetic kidney disease and cardiac autonomic neuropathy: insights on exercise rehabilitation.Journal of nephrology · 2025Review
- Selonsertib in Patients with Diabetic Kidney Disease: A Phase 2b Randomized Active Run-In Clinical Trial.Journal of the American Society of Nephrology : JASN · 2024Article
- Inhibition of Interleukin-33 to Reduce Glomerular Endothelial Inflammation in Diabetic Kidney Disease.Kidney international reports · 2024Article
- Non-Invasive Biomarkers for Diagnosis, Risk Prediction, and Therapy Guidance of Glomerular Kidney Diseases: A Comprehensive Review.International journal of molecular sciences · 2024Review
- Plasma Biomarkers and Incident CKD Among Individuals Without Diabetes.Kidney medicine · 2023Article
- Precision Medicine in Diabetic Kidney Disease: A Narrative Review Framed by Lived Experience.Canadian journal of kidney health and disease · 2023Review
- Molecular Pathways of Diabetic Kidney Disease Inferred from Proteomics.Diabetes, metabolic syndrome and obesity : targets and therapy · 2023Review
- Review of potential biomarkers of inflammation and kidney injury in diabetic kidney disease.Diabetes/metabolism research and reviews · 2022Review
- Targeting inflammation for the treatment of Diabetic Kidney Disease: a five-compartment mechanistic model.BMC nephrology · 2022Review
- Trajectories of kidney function in diabetes: a clinicopathological update.Nature reviews. Nephrology · 2021Review
- Circulating proteins protect against renal decline and progression to end-stage renal disease in patients with diabetes.Science translational medicine · 2021Article
- The Associations of Plasma Biomarkers of Inflammation With Histopathologic Lesions, Kidney Disease Progression, and Mortality-The Boston Kidney Biopsy Cohort Study.Kidney international reports · 2021Article
- Comparison of Circulating Biomarkers in Predicting Diabetic Kidney Disease Progression With Autoantibodies to Erythropoietin Receptor.Kidney international reports · 2021Article
- Intra-individual variability of eGFR trajectories in early diabetic kidney disease and lack of performance of prognostic biomarkers.Scientific reports · 2020Article
- Aortic pulse wave velocity, central pulse pressure, augmentation index and chronic kidney disease progression in individuals with type 2 diabetes: a 3- year prospective study.BMC nephrology · 2020Article
- DNA methylation mediates development of HbA1c-associated complications in type 1 diabetes.Nature metabolism · 2020Article
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13 authors.
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Abstract
Design of Phase III trials for diabetic nephropathy currently requires patients at a high risk of progression defined as within three years of a hard end point (end-stage renal disease, 40% loss of estimated glomerular filtration rate, or death). To improve the design of these trials, we used natural history data from the Joslin Kidney Studies of chronic kidney disease in patients with diabetes to develop an improved criterion to identify such patients. This included a training cohort of 279 patients with type 1 diabetes and 134 end points within three years, and a validation cohort of 221 patients with type 2 diabetes and 88 end points. Previous trials selected patients using clinical criteria for baseline urinary albumin-to-creatinine ratio and estimated glomerular filtration rate. Application of these criteria to our cohort data yielded sensitivities (detection of patients at risk) of 70-80% and prognostic values of only 52-63%. We applied classification and regression trees analysis to select from among all clinical characteristics and markers the optimal prognostic criterion that divided patients with type 1 diabetes according to risk. The optimal criterion was a serum tumor necrosis factor receptor 1 level over 4.3 ng/ml alone or 2.9-4.3 ng/ml with an albumin-to-creatinine ratio over 1900 mg/g. Remarkably, this criterion produced similar results in both type 1 and type 2 diabetic patients. Overall, sensitivity and prognostic value were high (72% and 81%, respectively). Thus, application of this criterion to enrollment in future clinical trials could reduce the sample size required to achieve adequate statistical power for detection of treatment benefits.
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