A team of epidemiology researchers has described a prognostic tool that predicts, exactly, the risk of renal disease in the terminal stage (ESRD), in patients with type I diabetes and type II.
The design of phase III tests, for diabetic nephropathy, currently requires a group of patients, difficult to obtain, with a high risk of progression, defined as within three years after an end point (ESRD, loss of 40% of the calculated glomerular filtration rate or death).
To improve the design of these essays, the researchers of the Harvard Faculty of Medicine (Boston, MA, USA) used data from the natural history of patients with chronic kidney disease and diabetes to develop an improved criterion to identify these patients.
The study group included a training cohort of 279 patients with type I diabetes and 134 final points in a maximum of three years, in addition to a validation cohort of 221 patients with type II diabetes and 88 final points.
Previous tests selected patients using clinical criteria for the basal urinary albumin/creatinine relationship and calculated glomerular filtration rate.The application of these criteria to the current cohort data showed sensibilities (detection of patients at risk) of 70-80% and prognostic values of only 52-63%.Next, the researchers applied the classification and analysis of regression trees, to select among all clinical and markers the optimal prognosis criteria that divided patients with type I diabetes, according to risk.
They found that the optimal criteria was a serum level of the tumor necrosis factor receptor 1 (TNFR1), of more than 4.3 nanograms/milliliter alone or 2.9-4.3 nanograms/milliliter with a creatinine albumin ratio, greater than 1900 milligrams/gram.This criterion produced similar results, both in type I diabetic patients.In general, sensitivity and prognostic value were high (72% and 81%, respectively).
"The global efficiency and profitability of clinical trials depend on the diagnostic tools used to register the study patients," said the main author of the study, Dr. Andrzej S. Krolewski, professor of medicine at the Faculty of Medicine at the Faculty of MedicineHarvard."If you hire people who are not at risk of progressing ESRD during the clinical trial period, statistical power decreases and nothing can be demonstrated."
"Surprisingly, when we use the TNF receiver to analyze the risk of ESRD, the risk was almost identical, both for type I diabetes and for type 2 diabetes. This implies that the etiologies are similar," said Dr. Krolewski.“This is a very important observation because, in the medical community, the impression is that the progression to the ESRD in type I is somehow different from type II.As a result, many clinical trials do not include patients with type I diabetes. Currently, about 80% of patients in these clinical trials do not provide any useful information if our criteria is used in patient recruitA thousand patients for a clinical trial will only need 400 patients. ”
The study was published in the digital edition of April 7, 2017 of Kidney International magazine.