Kidney Biopsies Using Standardized Protocol Safe Even in High-Risk Patients

DENVER — While patients considered at high risk are commonly restricted from receiving a kidney biopsy, findings from a prospective study of a large cohort showed very low rates of complications in these patients, challenging long-held perceptions. “Kidney biopsy can be performed safely even in patients traditionally considered at increased procedural risk when undertaken within a rigorous, standardized pathway,” said first author Dario Roccatello, MD, PhD, of the University of Turin, Italy, in a press statement.

ROCKY Protocol for Renal Biopsy Percutaneous native kidney biopsy remains the gold standard for diagnosing a wide range of kidney diseases; however, it carries a risk for severe bleeding and related vascular complications, particularly in high-risk patients. Risk factors include advanced age, renal impairment, obesity , anatomic renal abnormalities, and use of antithrombotic therapy.

To better evaluate outcomes of such high-risk patients receiving biopsies, Roccatello and colleagues conducted a prospective observational study of 1937 native kidney biopsies performed between January 2014 and June 2024. The biopsies were performed using the standardized ROCKY (Renal-biopsy Optimized Care and Knowledge Yielding safety pathway) protocol.

Roccatello presented the results here at Kidney Week 2026: American Society of Nephrology Annual Meeting . Of the biopsies, 1096 (56.6%) were from 801 patients presenting with one or more predefined high-risk features for biopsy-related complications, including 26.9% who were receiving a repeat biopsy.

About three quarters of those procedures (76.8%) involved patients who were hospitalized while the remaining 23.2% were outpatients. Overall, severe complications occurred in only 9 (0.8%) of the high-risk biopsies, with no significant differences in the incidence of severe complications between inpatients and outpatients ( P = .45).

The findings were consistent across subgroups, including older age (odds ratio [OR] 1.01 per year; P = .54), sex (OR, 0.98 for males; P = .89), serum creatinine (OR, 1.007 per mg/dL; P = .47), estimated glomerular filtration rate (OR, 0.99 mL/min/1.73 m 2 ; P = .61), and use of antiplatelet therapy (OR, 1.05; P = .77) or anticoagulants (OR, 0.95; P = .84).

The authors highlighted that the careful use of the ROCKY protocol was considered key in achieving the results. The strategy combines precautions including structured pre-biopsy assessment, risk factor correction, ultrasound-guided biopsy, and systematic post-procedure monitoring.

“These findings challenge traditional contraindication paradigms and support broader use of kidney biopsy, including in outpatient settings, when protocolized risk mitigation strategies are applied,” the authors concluded. “In addition, the comparable safety observed in outpatients supports expansion of outpatient biopsy programs with the potential to reduce unnecessary hospitalization and improve healthcare-resource utilization,” said Roccatello.

The results further support “access to kidney biopsy for patients who might otherwise be denied an important diagnostic and prognostic procedure,” he added. ‘Important Study’ Commenting on the research, Laith Al-Rabadi, MD, professor of medicine in the Division of Nephrology & Hypertension at the University of Utah in Salt Lake City, noted that the results shed important light on the challenges with high-risk patients.

“I think this is an important study because we often hesitate to perform kidney biopsies in patients whom we consider high-risk, particularly those with advanced kidney disease or other bleeding risk factors,” Al-Rabadi, who co-moderated the session, told Medscape Medical News . “What I found encouraging was that the investigators were able to perform biopsies in these patients with a relatively low rate of serious complications,” he said.

“To me, this suggests that we may be able to safely biopsy more of these patients than we traditionally thought, particularly when the procedure is performed by an experienced team with a standardized protocol.” Challenges Faced by Nephrologists “The challenge is that some of the patients who would benefit most from a biopsy are also the ones at higher risk of complications,” said Al-Rabadi.

“We are constantly weighing the risk of bleeding against the risk of missing a diagnosis or delaying treatment. There is not always an easy answer.” Notable limitations, in addition to being a single-center study, include that not every center can be assumed to utilize the same careful protocol used in this study, Al-Rabadi added.

In addition, the researchers reported routinely using desmopressin (DDAVP) to prevent bleeding, “which is interesting, but we cannot conclude from this study that desmopressin was responsible for the low bleeding rate,” he said. “While the overall results are reassuring, serious bleeding complications still occurred,” he noted.

Therefore, “we should not interpret the findings as suggesting that biopsies are without risk.” “For me, the main message is that being considered high-risk should not automatically exclude a patient from having a kidney biopsy,” Al-Rabadi said. “If the biopsy is likely to change how we treat the patient, we should carefully weigh the risks and benefits, rather than simply deciding against it because of the patient's risk factors.” Roccatello and Al-Rabadi reported no relevant financial relationships.