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Area of Science:

  • Radiology and Medical Imaging
  • Nephrology and Kidney Diseases
  • Pharmacovigilance

Background:

  • Contemporary gadolinium-based contrast agents (GBCAs) are used in MRI for patients with advanced chronic kidney disease (CKD) or end-stage renal disease (ESRD).
  • The perceived risk of nephrogenic systemic fibrosis (NSF) with these agents in this population is considered low, but data from large-scale, real-world studies are limited.
  • Accurate risk assessment is crucial for balancing the benefits of contrast-enhanced MRI against potential adverse events in patients with impaired renal function.

Purpose of the Study:

  • To estimate the real-world risk of NSF associated with contemporary GBCAs in patients diagnosed with advanced CKD or ESRD.
  • To compare the incidence of NSF in patients with advanced CKD/ESRD receiving GBCAs against a matched control group without renal dysfunction.

Main Methods:

  • Retrospective analysis of adult patients with stage 4-5 CKD or ESRD who received GBCAs between January 2010 and January 2025, identified from the TriNetX U.S. Network.
  • Propensity score matching (PSM) was employed to create a control group with similar demographic characteristics and comorbidities.
  • Primary endpoint: possible NSF (ICD-10 code L90.8); Secondary endpoint: possible NSF confounders. Assessment was conducted within one year of GBCA administration. Risk ratios (RRs) and Kaplan-Meier analysis were used.

Main Results:

  • A total of 73,022 adults with advanced CKD or ESRD who received GBCAs were identified. After PSM, the incidence of possible NSF codes was 0.05% in both the GBCA group and the control group (RR, 1.00; P > .99).
  • Rates of NSF confounder codes were similar between the groups (0.74% vs. 0.71%; RR, 1.05; P = .46).
  • Diagnostic code rates for NSF were comparable between patients receiving different types of contemporary GBCAs (ACR group II and macrocyclic agents) and controls without renal dysfunction.

Conclusions:

  • In this large, real-world analysis, the probability of a diagnostic code for possible NSF following contemporary GBCA administration in patients with advanced CKD or ESRD is exceedingly low.
  • The risk of NSF in this patient group receiving GBCAs is not significantly greater than that observed in matched controls without renal dysfunction.
  • Contemporary GBCAs appear safe regarding NSF risk in patients with advanced kidney disease when used in real-world clinical practice.