Pentoxifylline in Diabetic Kidney Disease

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 2510

Inclusion Criteria

Inclusion Criteria: A. Inclusion Criteria: 1. Type 2 diabetes. 2. 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, or - Group II: eGFR 30 to less than 45 mL/min/1.73 m2 with UACR > 30 mg/g or UPCR > 150 mg/g, or - Group III: eGFR 45 to less than 60 mL/min/1.73 m2 with UACR > 300 mg/g or UPCR > 500 mg/g 3. 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 > 30 mg/g, or - Group III: eGFR 45 to less than 60 mL/min/1.73 m2 with UACR > 300 mg/g Participants must be a United States Veteran, currently receiving care at a VA hospital with a local study team. Exclusion Criteria: 1. Type 1 diabetes 2. History of non-diabetic kidney disease 3. Severe comorbid conditions expected to reduce life expectancy to less than 1 year, as determined by LSI 4. Active substance abuse, homelessness, or other condition that is likely to result in participant non,ompliance as determined by the LSI 5. Previous organ or bone marrow transplant 6. Pregnancy, breast feeding or female of child-bearing potential unwilling to use a reliable form of contraception 7. A recent (within 3 months) cerebral hemorrhage 8. Current use of oral pentoxifylline 9. Hypersensitivity to pentoxifylline or any of the components of the formulation 10. Current use of systemic ketorolac, oral or IV (contraindicated with pentoxifylline) 11. Current use of riociguat (contraindicated with pentoxifylline) 12. Current use of dialysis 13. Unable to provide informed consent 14. or any condition that in the opinion of the LSI would make the potential participant non-compliant

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to ESRD or death

Secondary Outcome Measures

Name	Time	Method
Quality of life (KDQoL-SF);Time until doubling of serum creatinine;Incidence of congestive heart failure hospitalization (CHF);Incidence of a three-point MACE;Incidence of a peripheral vascular disease (PVD);Percentage of participants with 50% reduction in UACR from baseline;Rate of change in eGFR per year during the study period