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ACTIVE NOT RECRUITING

NCT03625648

PHASE4

Pentoxifylline in Diabetic Kidney Disease

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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.

Official title: CSP #2008 - Pentoxifylline in Diabetic Kidney Disease

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2376

Start Date

2019-11-18

Completion Date

2030-07-08

Last Updated

2025-12-17

Healthy Volunteers

Conditions

Diabetic Kidney Disease

Interventions

DRUG

Pentoxifylline

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

DRUG

Placebo

placebo

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

Locations (34)

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

Memphis VA Medical Center, Memphis, TN

Memphis, Tennessee, United States

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, United States

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, United States

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, United States

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, United States

Salem VA Medical Center, Salem, VA

Salem, Virginia, United States

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, United States

Clement J. Zablocki VA Medical Center, Milwaukee, WI

Milwaukee, Wisconsin, United States