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Kidney Week

Abstract: TH-PO1165

Long-Term Renal Safety of 177Lu-Dotatate in Patients with CKD: A Five-Year Follow-Up Study

Session Information

Category: Onconephrology

  • 1600 Onconephrology

Authors

  • Savani, Krupa Hareshkumar, Mayo Clinic in Florida, Jacksonville, Florida, United States
  • Fang, Zhihui, Mayo Clinic in Florida, Jacksonville, Florida, United States
  • Hobday, Timothy, Mayo Clinic Minnesota, Rochester, Minnesota, United States
  • Halfdanarson, Thor R., Mayo Clinic Minnesota, Rochester, Minnesota, United States
  • Kendi, Ayse Tuba, Mayo Clinic Minnesota, Rochester, Minnesota, United States
  • Johnson, Geoffrey B., Mayo Clinic Minnesota, Rochester, Minnesota, United States
  • Leung, Nelson, Mayo Clinic Minnesota, Rochester, Minnesota, United States
  • Manohar, Sandhya, Mayo Clinic in Florida, Jacksonville, Florida, United States
Background

Use of 177Lu Dotatate has expanded since its 2018 FDA approval, but long term renal safety data in chronic kidney disease (CKD), largely excluded from early trials, remain absent. CKD may heighten susceptibility to radiation related renal injury and delay radionuclide clearance. We evaluated 5 year renal outcomes in CKD versus non CKD patients to address this gap.

Methods

Retrospective cohort study of 177 patients (CKD n=88, non-CKD n=89) receiving 177Lu-Dotatate from (2018–2020), followed through 12/2025. Linear mixed-effects models examined eGFR trajectories adjusted for age, hypertension, diabetes, small bowel resection, diuretics, ACEi/ARB, cycles completed, and follow-up AKI.

Results

CKD patients were older (67.4 vs. 59.1 years, p<0.001) with lower baseline eGFR (median 54.5 vs. 85 ml/min, p<0.001) but comparable comorbidity burden otherwise. Non-CKD patients showed significant eGFR decline at all post-treatment follow-up timepoints (p<0.001), while CKD patients remained stable relative to baseline. On adjusted mixed-effects modeling, non-CKD patients declined faster in both absolute terms (−2.93 vs. −1.10 ml/min/year; difference +1.83, p<0.001) and relative terms (−4.7% vs. −2.2%/year; difference +2.6%, p=0.003). This differential was not explained by cumulative 177Lu dose (interaction p=0.44). Continuous baseline eGFR independently predicted eGFR slope (coefficient −0.083, p<0.001), suggesting the differential trajectory reflects starting renal function rather than CKD status per se. Incidence of significant renal decline (≥20% eGFR reduction) did not differ between groups (38.3% vs. 43.9%, p=0.465).

Conclusion

Over 5 years, 177Lu Dotatate did not selectively harm CKD kidneys — renal trajectory was driven by baseline eGFR, not CKD status. CKD patients declined at rates consistent with expected background comorbidity-related loss, while non CKD patients demonstrated a clinically meaningful eGFR decline warranting further study. These findings challenge the current paradigm of CKD focused renal surveillance and call for prospective studies incorporating extended follow up and more sensitive renal biomarkers to fully characterize the nephrotoxic potential of this therapy across the spectrum of kidney function. Acknowledging these limitations and the need for further study, 177Lu Dotatate remains a viable treatment option for patients with NETs and pre-existing CKD.