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40 VA hospitals test cheap drug to save kidneys in diabetes

NCT ID NCT03625648

Disease control Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether pentoxifylline, a medicine used since 1984 for leg blood vessel problems, can slow kidney damage and delay death in people with diabetic kidney disease. About 2,376 participants with type-2 diabetes and moderate-to-severe kidney decline are being followed at 40 VA hospitals. The main goal is to see if the drug prevents the need for dialysis or a kidney transplant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

2,376 people

The number who actually took part.

Started

Nov 2019

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diabetic kidney disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic kidney disease

Contacts and locations

Locations

  • Atlanta VA Medical and Rehab Center, Decatur, GA

    Decatur, Georgia, 30033-4004, United States

  • Bay Pines VA Healthcare System, Pay Pines, FL

    Bay Pines, Florida, 33744-0000, United States

  • Central Arkansas Veterans Healthcare System, Little Rock, AR

    Little Rock, Arkansas, 72205, United States

  • Cincinnati VA Medical Center, Cincinnati, OH

    Cincinnati, Ohio, 45220-2213, United States

  • Clement J. Zablocki VA Medical Center, Milwaukee, WI

    Milwaukee, Wisconsin, 53295-0001, United States

  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

    Philadelphia, Pennsylvania, 19104-4551, United States

  • Durham VA Medical Center, Durham, NC

    Durham, North Carolina, 27705-3875, United States

  • Edward Hines Jr. VA Hospital, Hines, IL

    Hines, Illinois, 60141-3030, United States

  • Harry S. Truman Memorial, Columbia, MO

    Columbia, Missouri, 65201-5275, United States

  • Hunter Holmes McGuire VA Medical Center, Richmond, VA

    Richmond, Virginia, 23249-0001, United States

  • Iowa City VA Health Care System, Iowa City, IA

    Iowa City, Iowa, 52246-2292, United States

  • James A. Haley Veterans' Hospital, Tampa, FL

    Tampa, Florida, 33612, United States

  • Kansas City VA Medical Center, Kansas City, MO

    Kansas City, Missouri, 64128-2226, United States

  • Lexington VA Medical Center, Lexington, KY

    Lexington, Kentucky, 40502-2235, United States

  • Memphis VA Medical Center, Memphis, TN

    Memphis, Tennessee, 38104-2127, United States

  • Michael E. DeBakey VA Medical Center, Houston, TX

    Houston, Texas, 77030-4211, United States

  • Minneapolis VA Health Care System, Minneapolis, MN

    Minneapolis, Minnesota, 55417-2309, United States

  • New Mexico VA Health Care System, Albuquerque, NM

    Albuquerque, New Mexico, 87108-5153, United States

  • North Florida/South Georgia Veterans Health System, Gainesville, FL

    Gainesville, Florida, 32608-1135, United States

  • Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

    Omaha, Nebraska, 68105-1850, United States

  • Phoenix VA Health Care System, Phoenix, AZ

    Phoenix, Arizona, 85012, United States

  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    Aurora, Colorado, 80045, United States

  • Salem VA Medical Center, Salem, VA

    Salem, Virginia, 24153-6404, United States

  • South Texas Health Care System, San Antonio, TX

    San Antonio, Texas, 78229-4404, United States

  • St. Louis VA Medical Center John Cochran Division, St. Louis, MO

    St Louis, Missouri, 63106-1621, United States

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

    Ann Arbor, Michigan, 48105-2303, United States

  • VA Loma Linda Healthcare System, Loma Linda, CA

    Loma Linda, California, 92357-1000, United States

  • VA Long Beach Healthcare System, Long Beach, CA

    Long Beach, California, 90822, United States

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

    Dallas, Texas, 75216-7167, United States

  • VA Palo Alto Health Care System, Palo Alto, CA

    Palo Alto, California, 94304-1207, United States

  • VA Portland Health Care System, Portland, OR

    Portland, Oregon, 97207-2964, United States

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

    Seattle, Washington, 98108-1532, United States

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

    Salt Lake City, Utah, 84148-0001, United States

  • Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC

    Columbia, South Carolina, 29209-1638, United States

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Other studies related to the condition(s) this trial covers.