Active — Not RecruitingPhase 4

Pentoxifylline in Diabetic Kidney Disease

United States2,376 participantsStarted 2019-11-18

Plain-language summary

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 participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Type-2 diabetes.
✓. Meet one of the following categories at a time that is greater than 90 days prior to randomization:
✓. Participants need to be in one of the following categories at the time of randomization:

Exclusion criteria

✕. 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
✕. Previous organ or bone marrow transplant
✕. Pregnancy, breast feeding or female of child-bearing potential unwilling to use a reliable form of contraception
✕. A recent (within 3 months) cerebral hemorrhage
✕. Current use of oral pentoxifylline

What they're measuring

Time to ESRD or death

Timeframe: 5 to 9 years

Trial details

NCT IDNCT03625648

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2028-01-03

View on ClinicalTrials.gov More Diabetic Kidney Disease trials