About the study

Pentoxifylline (PTX) is a medication that has been on the market since 1984 for use in disease in the blood vessels of the legs. There is some preliminary information that it may protect the kidneys from damage due to diabetes and other diseases. "Pentoxifylline in Diabetic Kidney Disease" is a study to bee conducted in 40 VA hospitals across the nation to determine definitively whether or not PTX can prevent worsening of kidney disease and delay death in patients with diabetic kidney disease.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Type-2 diabetes
2. Chronic Kidney Disease, stage 3 or 4 (eGFR 15-60 mL/min/1.73 m2) at the time of randomization and on one or more occasions 3 months or more prior to randomization
3. Participants need to be in one of the following categories at the time of randomization and on one or more occasions 3 months or more prior to randomization:
4. eGFR 15 to less than 30 mL/min/1.73 m2, or
5. eGFR 30 to less than 45 mL/min/1.73 m2 with UACR > 30 mg/g*, or
6. eGFR 45 to less than 60 mL/min/1.73 m2 with UACR > 300 mg/g**
7. *For screening purposes only, UPCR > 150 mg/g acceptable.
8. **For screening purposes only, UPCR > 500 mg/g acceptable.

Exclusion criteria

1. Type 1 diabetes
2. Known non-diabetic kidney disease
3. Severe comorbid conditions (expected to reduce life expectancy to less than 1 year, as determined by LSI)
4. Previous organ or bone marrow transplant
5. Pregnancy, breast feeding or females of child-bearing potential who are unwilling to use a reliable form of contraception
6. Presence of recent (within 3 months) cerebral hemorrhage
7. Currently using oral PTX
8. Hypersensitivity to PTX or any of the components of the formulation
9. Current use of ketorolac (contraindicated with PTX )
10. Current use of riociguat (contraindicated with PTX)
11. Unable to provide informed consent

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.