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Active, not recruiting Phase 4

Pentoxifylline in Diabetic Kidney Disease

NCT03625648 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 4
Started
2019-11-18
Last updated
2026-04-13

Condition(s) studied

Diabetic Kidney Disease

Investigational drug(s) / intervention(s)

Pentoxifylline →Placebo

Pentoxifylline: The non-specific phosphodiesterase inhibitor pentoxifylline (PTX) was approved by the FDA in 1984 for the treatment of peripheral vascular disease.

Placebo: placebo

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Time to ESRD or death — 5 to 9 years
    ESRD will be defined as need for chronic dialysis or renal transplantation.

Trial sites (34)

FacilityCityRegionStatus
Phoenix VA Health Care System, Phoenix, AZ Phoenix Arizona
Central Arkansas Veterans Healthcare System, Little Rock, AR Little Rock Arkansas
VA Loma Linda Healthcare System, Loma Linda, CA Loma Linda California
VA Long Beach Healthcare System, Long Beach, CA Long Beach California
VA Palo Alto Health Care System, Palo Alto, CA Palo Alto California
Rocky Mountain Regional VA Medical Center, Aurora, CO Aurora Colorado
Bay Pines VA Healthcare System, Pay Pines, FL Bay Pines Florida
North Florida/South Georgia Veterans Health System, Gainesville, FL Gainesville Florida
James A. Haley Veterans' Hospital, Tampa, FL Tampa Florida
Atlanta VA Medical and Rehab Center, Decatur, GA Decatur Georgia
Edward Hines Jr. VA Hospital, Hines, IL Hines Illinois
Iowa City VA Health Care System, Iowa City, IA Iowa City Iowa
Lexington VA Medical Center, Lexington, KY Lexington Kentucky
VA Ann Arbor Healthcare System, Ann Arbor, MI Ann Arbor Michigan
Minneapolis VA Health Care System, Minneapolis, MN Minneapolis Minnesota
Harry S. Truman Memorial, Columbia, MO Columbia Missouri
Kansas City VA Medical Center, Kansas City, MO Kansas City Missouri
St. Louis VA Medical Center John Cochran Division, St. Louis, MO St Louis Missouri
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE Omaha Nebraska
New Mexico VA Health Care System, Albuquerque, NM Albuquerque New Mexico
Durham VA Medical Center, Durham, NC Durham North Carolina
Cincinnati VA Medical Center, Cincinnati, OH Cincinnati Ohio
VA Portland Health Care System, Portland, OR Portland Oregon
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA Philadelphia Pennsylvania
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC Columbia South Carolina
Memphis VA Medical Center, Memphis, TN Memphis Tennessee
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX Dallas Texas
Michael E. DeBakey VA Medical Center, Houston, TX Houston Texas
South Texas Health Care System, San Antonio, TX San Antonio Texas
VA Salt Lake City Health Care System, Salt Lake City, UT Salt Lake City Utah
Hunter Holmes McGuire VA Medical Center, Richmond, VA Richmond Virginia
Salem VA Medical Center, Salem, VA Salem Virginia
VA Puget Sound Health Care System Seattle Division, Seattle, WA Seattle Washington
Clement J. Zablocki VA Medical Center, Milwaukee, WI Milwaukee Wisconsin
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03625648 on ClinicalTrials.gov ↗ ← All trials in Mexico