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Pentoxifylline for Diabetic Kidney Disease (PTXRx Trial)

Phase 4
Recruiting
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Type 2 diabetes
Participants must 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, Group II: eGFR 30 to less than 45 mL/min/1.73 m2 with UACR > 30 mg/g, or Group III: eGFR 45 to less than 60 mL/min/1.73 m2 with UACR > 300 mg/g
Must not have
History of non-diabetic kidney disease
Previous organ or bone marrow transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 to 9 years
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will study whether the drug pentoxifylline can prevent worsening kidney disease and death in patients with diabetic kidney disease.

Who is the study for?
This trial is for U.S. Veterans with Type 2 diabetes and diabetic kidney disease receiving care at a VA hospital. They must have specific levels of kidney function (eGFR) and urine albumin to creatinine ratio (UACR). Excluded are those allergic to PTX, on dialysis, with substance abuse issues, homeless, pregnant or not using contraception, recent cerebral hemorrhage sufferers, organ transplant recipients, unable to consent or expected to live less than a year.
What is being tested?
The study tests if Pentoxifylline (PTX), a drug used since 1984 for leg blood vessel diseases can protect kidneys in diabetic patients. Participants will either receive PTX or a placebo in this nationwide study across 40 VA hospitals to see if it prevents worsening of kidney disease and delays death.
What are the potential side effects?
While the side effects of Pentoxifylline aren't detailed here, common ones include nausea, dizziness, headache and digestive upset. Since it's been used for other conditions since the '80s its safety profile is known but monitoring for any adverse reactions during the trial will be important.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have type 2 diabetes.
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My kidney function falls into one of the specified groups based on my eGFR and UACR levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had kidney disease not caused by diabetes.
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I have had an organ or bone marrow transplant.
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I am not pregnant, breastfeeding, and if capable of childbearing, I agree to use contraception.
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I had a brain bleed within the last 3 months.
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I am currently taking oral pentoxifylline.
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I am not currently using ketorolac in any form.
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I am not taking riociguat.
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I am currently on dialysis.
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I am unable to understand and give consent for treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 to 9 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 to 9 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to ESRD or death
Secondary study objectives
Incidence of a peripheral vascular disease (PVD)
Incidence of a three-point MACE
Congestive heart failure
+4 more

Side effects data

From 2009 Phase 4 trial • 37 Patients • NCT00770328
50%
Nausea/Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pentoxifylline
Placebo

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PTXExperimental Treatment1 Intervention
Active drug
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pentoxifylline
2021
Completed Phase 4
~1080

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,668 Previous Clinical Trials
3,763,356 Total Patients Enrolled
David J LeeheyStudy ChairEdward Hines Jr. VA Hospital, Hines, IL
1 Previous Clinical Trials
36 Total Patients Enrolled

Media Library

Pentoxifylline (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03625648 — Phase 4
~932 spots leftby Jan 2028
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