New biomarkers could accurately predict the risk of renal failure among patients with type 1 and type 2 diabetes.
Early identification of renal disease is important for reducing the risk of end stage renal disease (ESRD), especially among patients with type 1 and type 2 diabetes. Current tests use urinary albumin to creatinine ratio (ACR) and estimated glomerular filtration rate to determine which patients may develop ESRD, but critics believe these criteria do not result in an accurate and timely diagnosis.
In a new study published by the Kidney International, the authors developed a novel prognostic tool that may predict the risk of ESRD among patients with diabetes. The new tool could be used in a clinical setting to more accurately analyze disease risk.
The authors said that the tool could also aid researchers in clinical trials of new treatments due to the increased accuracy of ESRD risk testing.
"Overall efficiency and cost effectiveness of clinical trials depends on the diagnostic tools used to enroll study patients," said senior study author Andrzej S. Krolewski, MD, PhD. "If you recruit people who are not at risk of progressing to ESRD during the clinical trial period, statistical power declines and you can't prove anything."
Previously, the team of researchers found a link between tumor necrosis factor receptor 1 (TNF1) and reduced renal function in diabetes. In the current study, the authors aimed to translate prior findings into a prognostic test that can be used by physicians and improve enrollment in clinical trials.
Included in the study were data from patients with diabetes and stage 3 and 4 chronic kidney disease who were followed up to 15 years. Through classification and regression trees (CARTs), the authors discovered that specific levels of circulating TNFR1 and ACR indicated a high risk of ESRD, according to the study.
The findings were then confirmed in patients with type 2 diabetes. The authors noted that the prognostic test for type 2 diabetes was very similar to type 1 diabetes.
"Remarkably, when we used the TNF receptor to analyze risk of ESRD, the risk was almost identical for both type 1 and type 2 diabetes. This implies that the etiologies are similar," Dr Krolewski said. "This is a very important observation because in the medical community, the impression is that the progression to ESRD in type 1 is somehow different from type 2. As a result, many clinical trials do not include patients with type 1."
The sensitivity value of the prognostic criterion was observed to be 72%, and a positive prognostic value of 81%, which means that the tool was able to accurately detect those at risk at the time of the test and detect those at risk within 3 years, according to the study.
The authors also determined the test could improve clinical trial enrollment. They found that the size of a hypothetical 3-year clinical trial could be decreased, while increasing statistical power, according to the study.
"Currently, about 80% of patients in these clinical trials provide no useful information," Dr Krolewski said. "If our criterion is used in the recruitment of patients, you will not need two or three thousand patients for a clinical trial, you will only need 400 patients."
The authors note that the TNF receptor may be a therapeutic target that should be further explored, the study concluded.