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PentoxifyllinePentoxifylline in Diabetic Kidney Disease

Sponsor:

VA Office of Research and Development

Code:

NCT03625648

Conditions

Diabetic Kidney Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pentoxifylline

Placebo

Study Details

Brief 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.

Conditions

Diabetic Kidney Disease

Study ID

NCT03625648

Start date

Nov 18, 2019

Status verified date

May, 2025

Completion date

Jul 8, 2030

Anticipated

Primary completion date

Jan 3, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2510 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PTX

Active drug

placebo comparator: Placebo

Placebo

Interventions

Pentoxifylline

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

Placebo

placebo

Primary outcome measure

Time to ESRD or death [ Time Frame: 5 to 9 years ]

Central Contacts and Locations

Central contacts

Douglas E Lammie, MPH RD

(708) 202-8387 douglas.lammie@va.gov

Cheryl C Odle, MBA

(708) 202-8387 cheryl.odle@va.gov

Locations

Phoenix VA Health Care System, Phoenix, AZ

Recruiting

Phoenix, Arizona, United States, 85012

Contacts

Penelope Baker, MD

Penelope.Baker@va.gov

Central Arkansas Veterans Healthcare System, Little Rock, AR

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Fatima Ayub, MD

Fatima.Ayub@va.gov

VA Loma Linda Healthcare System, Loma Linda, CA

Recruiting

Loma Linda, California, United States, 92357-1000

Contacts

Ronald Fernando, MD

Ronald.Fernando@va.gov

VA Long Beach Healthcare System, Long Beach, CA

Recruiting

Long Beach, California, United States, 90822

Contacts

Joline Joline, MD

joline.chen@va.gov

Aliya Asghar, MPH

aliya.asghar@va.gov

VA Palo Alto Health Care System, Palo Alto, CA

Recruiting

Palo Alto, California, United States, 94304-1207

Contacts

Yiming Lit, MD

yiming.lit@va.gov

Rocky Mountain Regional VA Medical Center, Aurora, CO

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Sophia Ambruso, DO

sophia.ambruso@va.gov

Bay Pines VA Healthcare System, Pay Pines, FL

Recruiting

Bay Pines, Florida, United States, 33744-0000

Contacts

Hemalatha Gutta, MD

Hemalatha.gutta@va.gov

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

Recruiting

Gainesville, Florida, United States, 32608-1135

Contacts

Ashutosh Shukla, MD

Ashutosh.Shukla@va.gov

James A. Haley Veterans' Hospital, Tampa, FL

Recruiting

Tampa, Florida, United States, 33612

Contacts

Jorge Lamarche, MD

jorge.lamarche@va.gov

Atlanta VA Medical and Rehab Center, Decatur, GA

Recruiting

Decatur, Georgia, United States, 30033-4004

Contacts

Lawrence Phillips, MD

Lawrence.Phillips@va.gov

Edward Hines Jr. VA Hospital, Hines, IL

Recruiting

Hines, Illinois, United States, 60141-3030

Contacts

David J Leehey

708-202-8387 David.Leehey@va.gov

Iowa City VA Health Care System, Iowa City, IA

Recruiting

Iowa City, Iowa, United States, 52246-2292

Contacts

Diana Jalal, MD

Diana.Jalal@va.gov

Lexington VA Medical Center, Lexington, KY

Recruiting

Lexington, Kentucky, United States, 40502-2235

Contacts

Dennis Karounos, MD

dennis.karounos@va.gov

VA Ann Arbor Healthcare System, Ann Arbor, MI

Recruiting

Ann Arbor, Michigan, United States, 48105-2303

Contacts

Timothy Bodnar, MD

timothy.bodnar@va.gov

Minneapolis VA Health Care System, Minneapolis, MN

Recruiting

Minneapolis, Minnesota, United States, 55417-2309

Contacts

Scott Reule, MD

scott.reule@va.gov

Harry S. Truman Memorial, Columbia, MO

Recruiting

Columbia, Missouri, United States, 65201-5275

Contacts

Kunal Chaudhary, MD

Kunal.Chaudhary@va.gov

Kansas City VA Medical Center, Kansas City, MO

Recruiting

Kansas City, Missouri, United States, 64128-2226

Contacts

Mariana Garcia-Touza, MD

mariana.garcia-touza@va.gov

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

Recruiting

Saint Louis, Missouri, United States, 63106-1621

Contacts

Geetha Maddukuri, MD

Geetha.Maddukuri@va.gov

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

Recruiting

Omaha, Nebraska, United States, 68105-1850

Contacts

Cyrus DeSouza, MD

cyrus.desouza@va.gov

New Mexico VA Health Care System, Albuquerque, NM

Recruiting

Albuquerque, New Mexico, United States, 87108-5153

Contacts

Brent Wagner, MD

brent.wagner@va.gov

Durham VA Medical Center, Durham, NC

Recruiting

Durham, North Carolina, United States, 27705-3875

Contacts

Patrick Pun, MD

patrick.pun@va.gov

Cincinnati VA Medical Center, Cincinnati, OH

Recruiting

Cincinnati, Ohio, United States, 45220-2213

Contacts

Sarmeela Saha, MD

Sarmeela.Saha@va.gov

VA Portland Health Care System, Portland, OR

Recruiting

Portland, Oregon, United States, 97207-2964

Contacts

Tonja Dirkx, MD

Tonja.Dirkx@va.gov

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

Recruiting

Philadelphia, Pennsylvania, United States, 19104-4551

Contacts

Ihab Wahba, MD

ihab.wahba@va.gov

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

Recruiting

Columbia, South Carolina, United States, 29209-1638

Contacts

Jennifer Othersen, MD

Jennifer.Othersen2@va.gov

Memphis VA Medical Center, Memphis, TN

Recruiting

Memphis, Tennessee, United States, 38104-2127

Contacts

Barry Wall, MD

barry.wall@va.gov

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

Recruiting

Dallas, Texas, United States, 75216-7167

Contacts

Eleanor Lederer, MD

Eleanor.Lederer@va.gov

Michael E. DeBakey VA Medical Center, Houston, TX

Recruiting

Houston, Texas, United States, 77030-4211

Contacts

Sankardass Navaneethan, MD

Sankardass.Navaneethan@va.gov

South Texas Health Care System, San Antonio, TX

Recruiting

San Antonio, Texas, United States, 78229-4404

Contacts

Jay Bucci, MD

jay.bucci@va.gov

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

Recruiting

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

Contacts

Srinivasan Beddhu, MD

Srinivasan.Beddhu@va.gov

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Recruiting

Richmond, Virginia, United States, 23249-0001

Contacts

Nilang Patel, MD

Nilang.Patel3@va.gov

Salem VA Medical Center, Salem, VA

Recruiting

Salem, Virginia, United States, 24153-6404

Contacts

Devasmita Dev, MD

devasmita.dev@va.gov

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

Recruiting

Seattle, Washington, United States, 98108-1532

Contacts

Kristina Utzschneider, MD

206-277-3568 Kristina.Utzschneider@va.gov

Clement J. Zablocki VA Medical Center, Milwaukee, WI

Recruiting

Milwaukee, Wisconsin, United States, 53295-0001

Contacts

Dawn Wolfgram

dawn.wolfgram@va.gov

More Information

Sponsor

VA Office of Research and Development

Last update posted

May 13, 2025

Last verified

May, 2025

Keywords

Diabetic Kidney disease
pentoxifylline
PTX

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-05-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.