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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 to 9 years

Awards & highlights

PTXRx 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.Check my eligibility

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.See study design

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.

PTXRx Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have type 2 diabetes.

Select...

My kidney function falls into one of the specified groups based on my eGFR and UACR levels.

PTXRx Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 to 9 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to ESRD or death

Secondary outcome measures

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%

Study treatment Arm

Pentoxifylline

Placebo

PTXRx 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

~1140

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,303,919 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How might consuming Pentoxifylline impact one's health adversely?

"Clinical data has validated pentoxifylline's safety, thus yielding a score of 3."

Answered by AI

Could you please summarize any prior research done on Pentoxifylline?

"Back in 2008, Pentoxifylline commenced its clinical testing at the Neonatal Intensive Care Unit - Shaare Zedek Medical Center. Since then, 18366 trials have been conducted and there are presently 10 live studies occurring across multiple sites with a focus on Richmond, Virginia."

Answered by AI

How many participants is the research team recruiting for this trial?

"Affirmative, the information on clinicaltrials.gov reveals that this clinical trial is actively trying to acquire participants. This study was first published on November 18th 2019 and updated as recently as May 27th 2022. Ultimately, it requires 2510 patients from 16 different medical centres for completion."

Answered by AI

What is the usual purpose of Pentoxifylline ingestion?

"Through the use of Pentoxifylline, medical professionals can ameliorate or eliminate symptoms associated with alcoholic liver diseases, venous leg ulcer (VLU), and intermittent claudication."

Answered by AI

How many medical facilities are undertaking this research?

"Currently, 16 different medical facilities are participating in this research. Richmond, Minneapolis and Decatur represent a few of the available locations. Thus, it is recommended that participants choose the closest clinic to them so as to minimize their commute if they decide to join."

Answered by AI

Are there any available vacancies in this research program?

"According to the data hosted on clinicaltrials.gov, this medical study is actively recruiting patients and was first posted in November 18th 2019. The most recent update was made on May 27th 2022."

Answered by AI