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Pentoxifylline for Diabetic Kidney Disease

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE, Omaha, NE
Diabetic Kidney DiseasePentoxifylline - Drug
Eligibility
18+
All Sexes

Study Summary

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

Eligible Conditions
  • Diabetic Kidney Disease

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

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Lumasiran
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canagliflozin

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 5 to 9 years

5 to 9 years
Incidence of a peripheral vascular disease (PVD)
Incidence of a three-point MACE
Congestive heart failure
Percentage of participants with 50% reduction in UACR from baseline
Quality of life (KDQoL-SF)
Rate of change in eGFR per year during the study period
Time to ESRD or death
Time until doubling of serum creatinine

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Tilmanocept Dose - 0.20 mg
2
Lumasiran
2
canagliflozin

Side Effects for

Pentoxifylline
50%Nausea/Vomiting
This histogram enumerates side effects from a completed 2009 Phase 4 trial (NCT00770328) in the Pentoxifylline ARM group. Side effects include: Nausea/Vomiting with 50%.

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.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2 Treatment Groups

PTX
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

2510 Total Participants · 2 Treatment Groups

Primary Treatment: Pentoxifylline · Has Placebo Group · Phase 4

PTX
Drug
Experimental Group · 1 Intervention: Pentoxifylline · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pentoxifylline
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 to 9 years

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,517 Previous Clinical Trials
2,728,518 Total Patients Enrolled
David J LeeheyStudy ChairEdward Hines Jr. VA Hospital, Hines, IL
1 Previous Clinical Trials
36 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have type 2 diabetes.
References

Frequently Asked Questions

How might consuming Pentoxifylline impact one's health adversely?

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

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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