Nephrology Month in Review: February 2025

HCPLive Nephrology Month in Review: February 2025

Building on a strong start to 2025 in January, February kept the field of nephrology on a fast track, delivering major developments in clinical trials, transplantation, and patient care.

The month saw announcements for phase 1, 2, and 3 data across a range of renal diseases, as well as intent to submit a supplemental New Drug Application for focal segmental glomerulosclerosis (FSGS). The US Food and Drug Administration (FDA) cleared the first-ever xenotransplant clinical trial of gene-edited pig kidneys, and Massachusetts General Hospital performed its second xenotransplant of a genetically edited pig kidney under FDA Expanded Access Protocol. The American Society of Nephrology (ASN) also released Kidney Health Guidance on the outpatient management of patients with dialysis-requiring acute kidney injury (AKI-D).

Check out this February 2025 nephrology month in review for a recap of HCPLive’s coverage of the top renal news and research from the past few weeks:

Renal Clinical Trial Developments

Monlunabant Misses Primary Endpoint in Phase 2 Diabetic Kidney Disease Trial

Novo Nordisk announced the completion of a phase 2 trial investigating the efficacy and safety of a once-daily 10 mg and 25 mg dose of monlunabant, formerly INV-202, in patients with diabetic kidney disease. According to a 2024 financial report from the company, the small molecule oral cannabinoid receptor 1 inverse agonist missed the trial’s primary endpoint for urine albumin-creatinine ratio improvement but will continue to be evaluated for clinical development.

Tonix Announces Positive Topline Phase 1 Data for TNX-1500

Tonix Pharmaceuticals announced positive topline data from its phase 1, single ascending dose trial of TNX-1500 in healthy participants, with results demonstrating its safety, tolerability, pharmacokinetics, and pharmacodynamics. Pending alignment with the FDA in an end-of-phase 1 meeting, the company plans to pursue a phase 2 study of TNX-1500 in kidney transplant recipients.

REGENCY: Obinutuzumab Proves Efficacy in Lupus Nephritis

Results from the phase 3 REGENCY trial highlight obinutuzumab (Gazya/Gazyvaro)’s superiority versus standard of care therapy alone for achieving a complete renal response in patients with active lupus nephritis. In the trial, 46.4% of patients using obinutuzumab achieved a complete renal response, representing a 13.4% adjusted difference relative to standard of care therapy alone.

Travere Therapeutics Plans FSGS Submission for Sparsentan

Travere Therapeutics announced its intent to submit a supplemental New Drug Application (sNDA) for sparsentan (Filspari) to the FDA for the treatment of FSGS. The announcement followed the completion of a Type C meeting with the FDA and discloses the company’s intent to submit around the end of Q1 2025, with the sNDA based on existing data from the phase 3 DUPLEX and phase 2 DUET studies.

Developments in Xenotransplant

FDA Clears First Xenotransplant Trial for Gene-Edited Kidneys

On February 3, the FDA cleared United Therapeutics’ Investigational New Drug application to initiate a clinical study of the company’s investigational UKidney™ derived from a 10 gene-edited source pig, with the first xenotransplant expected to be performed around mid-year 2025. The study is planned to enroll an initial cohort of 6 patients with end-stage renal disease (ESRD), expanding to up to 50 participants, and is intended to support a Biologics License Application with the FDA.

Second Xenotransplant with Gene-Edited Pig Kidney Performed at Mass General

In March 2024, Massachusetts General Hospital became the first hospital in the world to transplant a genetically edited pig kidney into a living human. Now, Mass General has successfully completed a second xenotransplant of a genetically edited pig kidney into a 66-year-old male patient who had been on dialysis for more than 2 years due to ESKD.

The latest procedure was performed on January 25, 2025, by surgeons at the Mass General Transplant Center under FDA Expanded Access Protocol granted in December 2024, which is planned to support 2 additional xenotransplants this year.

Dialysis News and Research

ASN Releases Guidance on Outpatient Management of Dialysis-Requiring AKI

On February 27, ASN released its Kidney Health Guidance on the outpatient management of patients with AKI-D to address the unique, individualized care needs of these patients.

“This new guidance will help facilitate the transition from the hospital setting to outpatient care for people with AKI-D and help care teams identify the early signs of possible recovery in order to promote a life free of kidney disease and its consequences,” said Kathleen Liu, MD, PhD, a professor of medicine and anesthesia in the divisions of nephrology and critical care medicine at the University of California San Francisco and chair of the Kidney Health Guidance Oversight Committee.

Frailty Linked to Mortality, Falls, Hospitalizations in Dialysis Patients

Findings from this systematic review and meta-analysis shed light on the prevalence of frailty among patients undergoing dialysis, ranging from 12.1% to 82.0% in 26 included articles. Findings also call attention to its association with adverse outcomes, including mortality, falls, and hospitalization.