Kidney Week

Abstract: TH-PO1243

The Veterans Affairs Pentoxifylline in Diabetic Kidney Disease (VA PTXRx) Study: Baseline Characteristics

Session Information

• Late-Breaking Research Posters
  October 22, 2026 | Location: Exhibit Hall A, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: CKD (Non-Dialysis)

• 2202 CKD (Non-Dialysis): Clinical, Outcomes, and Trials

Authors

• Leehey, David J., Edward Hines Junior Veterans Affairs Hospital, Hines, Illinois, United States

David J. Leehey, MD

• Agarwal, Rajiv, Richard L Roudebush VA Medical Center, Indianapolis, Indiana, United States

Rajiv Agarwal, MD, MS, FASN

• Xing, Bin, Edward Hines Junior VA Hospital Cooperative Studies Program, Hines, Illinois, United States

Bin Xing, PhD

• Clise, Christina Elaine, VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, New Mexico, United States

Christina Elaine Clise, PharmD

• Navaneethan, Sankar D., Michael E DeBakey VA Medical Center, Houston, Texas, United States

Sankar D. Navaneethan, MD, MS, MPH, FASN

• Utzschneider, Kristina M., VA Puget Sound Health Care, Seattle, Washington, United States

Kristina M. Utzschneider, MD

• Lammie, Douglas Edward, Edward Hines Junior VA Hospital Cooperative Studies Program, Hines, Illinois, United States

Douglas Edward Lammie, RD, MPH

• Wei, Yongliang, Edward Hines Junior VA Hospital Cooperative Studies Program, Hines, Illinois, United States

Yongliang Wei, MS

• Polzin, Linda, Edward Hines Junior VA Hospital Cooperative Studies Program, Hines, Illinois, United States

Linda Polzin, RN

• Glomb, Blake Sterling, Edward Hines Junior VA Hospital Cooperative Studies Program, Hines, Illinois, United States

Blake Sterling Glomb, MPH, MSW

• Carlson, Kimberly, Edward Hines Junior VA Hospital Cooperative Studies Program, Hines, Illinois, United States

Kimberly Carlson, MS

Background

Experimental and clinical data suggest that the non-specific phosphodiesterase inhibitor pentoxifylline (PTX) reduces proteinuria and may delay the progression of diabetic kidney disease (DKD). However, no large-scale randomized clinical trial has determined whether PTX can reduce end-stage kidney disease (ESKD) and mortality in DKD.

Methods

VA PTXRx is a randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical trial designed to test the hypothesis that PTX, when added to usual care, prolongs the time to kidney failure or death in type 2 diabetic (T2D) patients with DKD compared to usual care plus placebo. Enrolled patients at very high risk for ESKD and/or death were randomized in a 1:1 ratio to either PTX 400 mg twice daily or matching placebo using randomly permuted blocks with stratification for site, renin-angiotensin-aldosterone (RAAS) inhibitor use, and chronic kidney disease (CKD) stage. The study is event-driven, requiring 646 primary events (ESKD (chronic dialysis or transplantation) or death) to achieve 80% power to detect a relative risk reduction of 19% with PTX.

Results

Between December 2019 and November 2025, 2376 participants at 34 VA hospitals in the USA were randomized. The mean age at randomization was 72.3 years (SD 7.7), with 97% being male. The mean baseline eGFR was 33.3 mL/min/1.73 m² (SD 9.4). The median urinary albumin to creatinine ratio (UACR) was 401 mg/g (IQR 122-1076). At baseline, the usage of RAAS inhibitors was 80.0%, sodium-glucose transporter-2 (SGLT2) inhibitors 52.9%, glucagon-like peptide-1 (GLP-1) receptor agonists 33.2%, and finerenone 25.4%. The majority (88%) of participants had stage 3B or 4 CKD (eGFR < 45 mL/min/1.73m²).

Conclusion

The results, anticipated in 2027, are expected to determine whether PTX should be a treatment option for patients with high-risk DKD. If it proves effective, its access will not be restricted by the high costs often associated with newer branded medications.

Funding

• Veterans Affairs Support