Pentoxifylline in Diabetic Kidney Disease

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Aug 8, 2018

Keywords

ClinConnect Summary

The clinical trial titled "Pentoxifylline in Diabetic Kidney Disease" is studying whether a medication called pentoxifylline (PTX) can help protect the kidneys from damage in patients with diabetic kidney disease. This trial is being conducted in 40 VA hospitals across the United States and aims to find out if PTX can prevent the worsening of kidney problems and possibly extend the lives of those affected by this condition. The study is currently recruiting participants, specifically U.S. Veterans aged 65 to 74 who have type 2 diabetes and specific levels of kidney function, known as eGFR, along with certain protein levels in their urine.

To be eligible for the study, participants must have type 2 diabetes and meet certain kidney function criteria, but they cannot have type 1 diabetes, severe other health problems, or a history of non-diabetic kidney disease. During the trial, participants will take pentoxifylline and be closely monitored for any changes in their kidney health. It's important for potential participants to understand that they will need to provide informed consent and be willing to follow the study guidelines. This trial could provide valuable information on a new way to help protect kidney health in those living with diabetes.

Gender

ALL

Eligibility criteria

• 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 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
• 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 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.
• 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