Pentoxifylline in Diabetic Kidney Disease

NCT03625648 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2008
• Study Type: interventional
• Target: 2,376
• Locations: 1 country
• Sites: 34

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

Keywords

Diabetic Kidney disease; pentoxifylline; PTX

Outcome Measures

Primary Outcomes (1)

• Time to ESRD or death

  ESRD will be defined as need for chronic dialysis or renal transplantation.

  5 to 9 years

Secondary Outcomes (7)

• Quality of life (KDQoL-SF)

  5 to 9 years

• Time until doubling of serum creatinine

  5 to 9 years

• Incidence of congestive heart failure hospitalization (CHF)

  5 to 9 years

• Incidence of a three-point MACE

  5 to 9 years

• Incidence of a peripheral vascular disease (PVD)

  5 to 9 years

Study Arms (2)

PTX

EXPERIMENTAL

Active drug

Drug: Pentoxifylline

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Pentoxifylline DRUG

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

PTX

Placebo DRUG

placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (34)

Phoenix VA Health Care System, Phoenix, AZ

Phoenix, Arizona, 85012, United States

Location

Central Arkansas Veterans Healthcare System, Little Rock, AR

Little Rock, Arkansas, 72205, United States

Location

VA Loma Linda Healthcare System, Loma Linda, CA

Loma Linda, California, 92357-1000, United States

Location

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, 90822, United States

Location

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045, United States

Location

Bay Pines VA Healthcare System, Pay Pines, FL

Bay Pines, Florida, 33744-0000, United States

Location

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

Gainesville, Florida, 32608-1135, United States

Location

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

Location

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-3030, United States

Location

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, 52246-2292, United States

Location

Lexington VA Medical Center, Lexington, KY

Lexington, Kentucky, 40502-2235, United States

Location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

Location

Harry S. Truman Memorial, Columbia, MO

Columbia, Missouri, 65201-5275, United States

Location

Kansas City VA Medical Center, Kansas City, MO

Kansas City, Missouri, 64128-2226, United States

Location

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

St Louis, Missouri, 63106-1621, United States

Location

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

Omaha, Nebraska, 68105-1850, United States

Location

New Mexico VA Health Care System, Albuquerque, NM

Albuquerque, New Mexico, 87108-5153, United States

Location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

Cincinnati VA Medical Center, Cincinnati, OH

Cincinnati, Ohio, 45220-2213, United States

Location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964, United States

Location

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

Philadelphia, Pennsylvania, 19104-4551, United States

Location

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

Columbia, South Carolina, 29209-1638, United States

Location

Memphis VA Medical Center, Memphis, TN

Memphis, Tennessee, 38104-2127, United States

Location

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

Dallas, Texas, 75216-7167, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

Location

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, 78229-4404, United States

Location

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

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

Location

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, 23249-0001, United States

Location

Salem VA Medical Center, Salem, VA

Salem, Virginia, 24153-6404, United States

Location

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

Seattle, Washington, 98108-1532, United States

Location

Clement J. Zablocki VA Medical Center, Milwaukee, WI

Milwaukee, Wisconsin, 53295-0001, United States

Location

Related Publications (2)

• Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.

  PMID: 37916745 DERIVED

• Leehey DJ, Carlson K, Reda DJ, Craig I, Clise C, Conner TA, Agarwal R, Kaufman JS, Anderson RJ, Lammie D, Huminik J, Polzin L, McBurney C, Huang GD, Emanuele NV. Pentoxifylline in diabetic kidney disease (VA PTXRx): protocol for a pragmatic randomised controlled trial. BMJ Open. 2021 Aug 16;11(8):e053019. doi: 10.1136/bmjopen-2021-053019.

  PMID: 34400461 DERIVED

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• David J Leehey

  Edward Hines Jr. VA Hospital, Hines, IL

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Double-blind, placebo controlled

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 10, 2018
• Study Start: November 18, 2019
• Primary Completion (Estimated): January 3, 2028
• Study Completion (Estimated): July 8, 2030
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (34)