6 Nephrology Headlines You Missed in December 2025

December wrapped up 2025 with new research to curate a more granular understanding of treatment strategies in chronic kidney disease (CKD), especially in end-stage kidney disease (ESKD), and IgA nephropathy (IgAN). Important investigations delved into the benefits of different dialysis and transplantation modalities, while newly approved therapies and disease management strategies may guide future approaches in nephrology.

In the pharmacologic landscape, the US Food and Drug Administration (FDA) granted Breakthrough Device Designation to Nephrodite’s Holly™ implantable, continuous dialysis system in patients with ESKD, with the proposed potential to improve the quality of life burden in patients on dialysis once first-in-human clinical trials are enabled in 2026. Furthermore, the FDA approved a supplemental New Drug Application (sNDA) for the furosemide On-Body Infusor (Furoscix) to treat edema associated with chronic heart failure (HF) and CKD in pediatric patients. Additionally, the FINE-ONE trial shed light on the promising results of finerenone in patients with IgAN, especially on key indicators of CKD severity, including reduced proteinuria and stabilized estimated glomerular filtration rate (eGFR).

Research on late-stage renal disease treatment strategies connected clinicians with informed insight into patient outcomes and specific risk factors. By understanding variations between peritoneal dialysis (PD) and hemodialysis (HD), as well as different kidney transplantation modalities, new data may support refined choices for patients and clinicians. Specifically, investigators linked increased physical activity to reduced mortality in PD and improved cognitive outcomes in PD compared to HD in respective studies. In a post-safety “safety net” era comparison between kidney-after-liver transplantation (KALT) and simultaneous liver-kidney transplantation (SLKT), investigators found notable differences in eGFR, but similar allograft survival outcomes. Overall, this research may offer a fresh perspective on renal care. 

Throughout December 2025, HCPLive provided editorial coverage for FDA approvals and designations, significant trials, and new disease treatment strategies to produce data-driven and patient-informed healthcare for clinicians. Read below for more key insights and data!

FDA Grants Breakthrough Device Designation to Holly Implantable Dialysis System

On December 15, 2025, the FDA granted Breakthrough Device Designation to Nephrodite’s Holly™ implantable, continuous dialysis system in patients with ESKD, supported by data from the multi-day, large animal study demonstrating sustained kidney function replacement with strong safety and performance outcomes.

“Dialysis sustains life, but at tremendous cost to a patient’s freedom and physiology,” Hiep Nguyen, MD, co-founder and SVP of Science and Technology at Nephrodite, said in a statement. “Holly represents a complete rethinking of kidney replacement, with a continuously functioning implant capable of matching the body’s natural rhythm. It’s both a scientific milestone and a human one.”

The company is preparing for Good Laboratory Practice (GLP) studies and subsequent regulatory submissions to enable first-in-human clinical trials.

FDA Approves FUROSCIX On-Body Injector for Pediatric Patients, Accepts sNDA for ReadyFlow Autoinjector

On December 23, 2025, the FDA approved an sNDA for the furosemide On-body Infusor to treat edema associated with chronic HF and CKD in pediatric patients who weigh ≥ 43 kg. The device was previously approved in 2022 for the treatment of edema in adults with chronic HF, and in 2025, it received approval for adults with CKD. This third approval delivers all post-marketing requirements defined in the initial approval letter under the Pediatric Research Equity Act.

“The FUROSCIX ReadyFlow Autoinjector marks a key milestone in expanding patient options and improving care,” Michael Castagna, PharmD, chief executive officer at MannKind Corporation, said in a separate statement regarding the acceptance. “By delivering treatment in under 10 seconds, the ReadyFlow Autoinjector has the potential to transform how adults with chronic heart failure or chronic kidney disease manage episodes of fluid buildup—providing faster relief, reducing hospital admissions, and lowering overall healthcare costs.”

Finerenone Shows Promise in IgAN: Reduced Proteinuria, Stable Kidney Function

In patients with IgAN receiving full supportive care, treatment with finerenone has demonstrated a significant reduction in their protein-to-creatinine ratio in addition to a stabilized eGFR.

In the FINE-ONE trial, investigators observed a 28.48% (P = .003) and 31.33% (P = .003) reduction in proteinuria at 2 and 6 months, respectively, compared with baseline. At 8 months, proteinuria decreased 39.69%, falling from 0.38 (0.28 to 0.75) g/g to 0.24 (0.16 to 0.47) g/g (P = .02). Investigators further noted statistically insignificant eGFR fluctuations at 2 and 4 months, 54.99 ± 27.49 mL/min/1.73 m² (P = .42) and 58.77 ± 15.78 mL/min/1.73 m² (P = .34).

Safety Net’s Kidney After Liver Transplant Linked to Reduced eGFR

When comparing outcomes between the ESKD treatment modalities, KALT and SLKT, in accordance with the Organ Procurement and Transplantation Network’s 2017-established safety net era, research demonstrated similar allograft survival, but different eGFR.

At 1-year post-kidney transplant, investigators noted similar kidney allograft survival rates, with 97.7% for KALT (95% Confidence Interval [CI], 96.0 to 98.7) and 96.8% for SLKT (95% CI, 96.0 to 97.4; P = .43). Patient survival rates were increased in KALT with a rate of 96.7% (95% CI, 94.8 to 98.0) compared to 93.9% in SLKT (95% CI, 92.9 to 94.8; P = .02). The mean difference in eGFR between KALT and SLKT was −4.7 mL/min/1.73 m2 (95% CI, −7.0 to −2.4; P <.001) in the propensity score matched analysis.

Podometrics Could Guide IgAN Treatment While Reducing Invasiveness

Based on the podocyte depletion hypothesis, investigators conducted a retrospective, single-center observational cohort study to evaluate podometric's ability to monitor disease activity. Analyzing kidney biopsy specimens from patients with IgAN, investigators measured the associations between podometric parameters, Oxford classification, and eGFR.

Multivariate analysis revealed reduced podocyte number as the only factor independently associated with eGFR decline. Patients with established markers of chronic kidney damage, such as segmental sclerosis (S1) and tubular atrophy/interstitial fibrosis (T1/2), had decreased podocyte density and number. Additionally, investigators found an association between elevated podocyte markers, NPHS1 and NPHS2, with E1 and C1/C2 lesions.

Peritoneal Dialysis Linked To Improved Cognitive Function In CKD

Research compared PD to HD in patients with CKD, reporting improved cognitive outcomes associated with PD. Regardless of findings, investigators emphasized the importance of individualized dialysis modalities.

The pooled analysis demonstrated benefits from PD by the majority of factors assessed, including executive function (Standardized Mean Difference [SMD], − 0.39; 95% CI, − 0.61 to − 0.16; P = .0008; Heterogeneity [I2], 31%), global cognitive function (SMD, − 0.46; 95% CI, − 0.62 to − 0.29; P < .00001; I2, 49%), reduced risk of dementia (Odds Ratio [OR], 1.68; 95% CI, 1.25 to 2.25; P = .0006; I2, 94%), increased processing speed (SMD, − 0.28; 95% CI − 0.47 to − 0.08; P = .005; I2, 0%), and memory scores (SMD, − 0.35; 95% CI, − 0.62 to − 0.06; P = .01; I2, 0%).

Related: Increased Physical Activity Linked to Reduced Mortality In Peritoneal Dialysis; Serum Albumin Levels Can Predict Increased Cancer Risk in Hemodialysis