The rate of nephrogenic systemic fibrosis (NSF) following administration of gadolinium-based contrast agents (GBCAs) in patients with advanced chronic kidney disease (CKD) or end-stage renal disease (ESRD) is low, researchers have reported.
In fact, the rate is comparable to that in patients who receive GBCAs but do not have these kidney conditions, wrote a team led by medical student Adarsh Mallepally of Virginia Commonwealth University in Richmond.
“[Our study] found exceedingly low rates of possible nephrogenic systemic fibrosis diagnoses following administration of GBCAs, and these rates were not higher in patients with advanced chronic kidney disease or end-stage renal disease,” it noted.
Concern about NSF associated with the use of GBCAs in patients with severe kidney disease arose in the early 2000s, the investigators explained, writing that by 2006, the U.S. Food and Drug Administration (FDA) issued a public health advisory about the risks of the condition in patients with renal dysfunction who underwent imaging with GBCAs. In addition, the American College of Radiology (ACR) classified GBCAs regarding their association with NSF, creating a Group 1 category of early GBCAs with the most NSF cases and a Group 2 category with “few, if any, unconfounded cases” of NSF (aka, “contemporary GBCAs”). After the FDA’s warning and the ACR’s categorization, reports of NSF cases decreased.
Yet the “residual risk” of NSF related to this Group 2 category of GBCAs remains unclear. The researchers conducted a study to assess this risk that included 73,022 adults with advanced CKD or ESRD who received GBCAs between January 2010 and January 2025. They took data from the TriNetX U.S. Network and performed propensity score matching with a control group with similar demographic characteristics and comorbidities. They also tracked any NSF diagnostic codes assigned to study participants and calculated risk ratios (RR) to determine the occurrence and mortality rates of possible NSF.
Overall, Mallepally and colleagues reported that of the total patient cohort, 0.05% of those with advanced CKD and 0.74% of those with ESRD had “possible NSF” diagnostic codes, while 0.05% and 0.71% of those without advanced CKD or ESRD had them — results that translated into similar risk ratios between the two groups (RR, 1, p> 0.99 for those with CKD or ESRD and 1.05, p = 0.46 for those without these conditions, respectively).
The team called for future studies with “more rigorous screening and classification processes for potential NSF events are needed to confirm our findings, which would impact risk versus benefit considerations among clinicians for patients with advanced CKD or ESRD who have indications for contrast-enhanced MRI studies.”
In an accompanying editorial, Xiaohu Li, MD, PhD, of First Affiliated Hospital of Anhui Medical University in Hefei, Anhui, China, wrote that “the findings of this study are clinically meaningful and reinforce the safety profile of modern GBCAs in patients with advanced renal dysfunction,” and that the results “should reassure both clinicians and patients, supporting the appropriate use of GBCA-enhanced MRI when clinically indicated.”
The full study can be found here.