Pentoxifylline in Diabetic Kidney Disease

Running, not enrolling · Phase 4 · Has a placebo group

Conditions studied: Diabetic Kidney Disease

In brief

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.

Key facts

Study ID

NCT03625648

Run by

VA Office of Research and Development

People needed

2376

Starts

2019-11-18

Expected to finish

2030-07-08

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• Hypersensitivity to pentoxifylline or any of the components of the formulation
• 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
• or any condition that in the opinion of the LSI would make the potential participant non-compliant

Where it is running

• Phoenix VA Health Care System, Phoenix, AZ — Phoenix, Arizona, United States
• Central Arkansas Veterans Healthcare System, Little Rock, AR — Little Rock, Arkansas, United States
• VA Loma Linda Healthcare System, Loma Linda, CA — Loma Linda, California, United States
• VA Long Beach Healthcare System, Long Beach, CA — Long Beach, California, United States
• VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California, United States
• Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora, Colorado, United States
• Bay Pines VA Healthcare System, Pay Pines, FL — Bay Pines, Florida, United States
• North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States
• James A. Haley Veterans' Hospital, Tampa, FL — Tampa, Florida, United States
• Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, United States
• Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, United States
• Iowa City VA Health Care System, Iowa City, IA — Iowa City, Iowa, United States
• Lexington VA Medical Center, Lexington, KY — Lexington, Kentucky, United States
• VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor, Michigan, United States
• Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States
• Harry S. Truman Memorial, Columbia, MO — Columbia, Missouri, United States
• Kansas City VA Medical Center, Kansas City, MO — Kansas City, Missouri, United States
• St. Louis VA Medical Center John Cochran Division, St. Louis, MO — St Louis, Missouri, United States
• Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE — Omaha, Nebraska, United States
• New Mexico VA Health Care System, Albuquerque, NM — Albuquerque, New Mexico, United States
• Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States
• Cincinnati VA Medical Center, Cincinnati, OH — Cincinnati, Ohio, United States
• VA Portland Health Care System, Portland, OR — Portland, Oregon, United States
• Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA — Philadelphia, Pennsylvania, United States
• Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC — Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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