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Using Pentoxifylline to Treat Diabetic Kidney Disease

CSP #2008 - Pentoxifylline in Diabetic Kidney Disease

PHASE4 · VA Office of Research and Development · NCT03625648

This study is testing if a medication called pentoxifylline can help improve kidney function and reduce the risk of death in veterans with diabetic kidney disease.

Quick facts

PhasePHASE4
Study typeInterventional
Enrollment2510 (estimated)
Ages18 Years and up
SexAll
SponsorVA Office of Research and Development (fed)
Locations35 sites (Phoenix, Arizona and 34 other locations)
Trial IDNCT03625648 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of pentoxifylline (PTX), a medication approved for peripheral vascular disease, on patients with diabetic kidney disease (DKD). Conducted across 40 VA hospitals, the trial aims to determine if PTX can prevent the worsening of kidney function and reduce mortality in individuals with DKD. The study will compare the outcomes of patients receiving PTX against those receiving a placebo, focusing on kidney health and inflammation markers. Given the high prevalence of DKD among U.S. Veterans, this research seeks to provide a novel treatment option for this serious condition.

Who should consider this trial

Good fit: Ideal candidates include U.S. Veterans with type-2 diabetes and varying degrees of kidney impairment.

Not a fit: Patients with kidney function above the specified thresholds or those not diagnosed with type-2 diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new therapeutic option to slow the progression of diabetic kidney disease and improve survival rates.

How similar studies have performed: While pentoxifylline has shown promise in smaller studies, this large-scale trial is necessary to confirm its efficacy in diabetic kidney disease.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Phoenix, Arizona and 34 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Diabetic Kidney Disease, Diabetic Kidney disease, pentoxifylline, PTX

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.