Pentoxifylline in Diabetic Kidney Disease

Prior treatment

• Previous organ or bone marrow transplant

Other illness

• Type 1 diabetes
• History of non-diabetic kidney disease
• Severe comorbid conditions expected to reduce life expectancy to less than 1 year, as determined by LSI
• Active substance abuse, homelessness, or other condition that is likely to result in participant non,ompliance as determined by the LSI
• A recent (within 3 months) cerebral hemorrhage
• Hypersensitivity to pentoxifylline or any of the components of the formulation
• or any condition that in the opinion of the LSI would make the potential participant non-compliant

Other

• Pregnancy, breast feeding or female of child-bearing potential unwilling to use a reliable form of contraception
• Current use of oral pentoxifylline
• Current use of systemic ketorolac, oral or IV (contraindicated with pentoxifylline)
• Current use of riociguat (contraindicated with pentoxifylline)
• Current use of dialysis
• Unable to provide informed consent

• Type-2 diabetes.
• Meet one of the following categories at a time that is greater than 90 days prior to randomization:
  • Group I: eGFR 15 to less than 30 mL/min/1.73 m2 regardless of the degree of albuminuria/proteinuria, or
  • Group II: eGFR 30 to less than 45 mL/min/1.73 m2 with UACR greater than or equal to (\>) 30 mg/g or UPCR greater than or equal to (\>) 150 mg/g, or
  • Group III: eGFR 45 to less than 60 mL/min/1.73 m2 with UACR greater than or equal to (\>) 300 mg/g or UPCR greater than or equal to (\>)500 mg/g
• Participants need to be in one of the following categories at the time of randomization:
  • Group I: eGFR 15 to less than 30 mL/min/1.73 m2, or
  • Group II: eGFR 30 to less than 45 mL/min/1.73 m2 with UACR greater than or equal to (\>) 30 mg/g, or
  • Group III: eGFR 45 to less than 60 mL/min/1.73 m2 with UACR greater than or equal to (\>) 300 mg/g
  • Participants must be a United States Veteran, currently receiving care at a VA hospital with a local study team.