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Pentoxifylline in Diabetic Kidney Disease
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
🗓️ Study Start (Actual) 18 November 2019
🗓️ Primary Completion (Estimated) 3 January 2028
✅ Study Completion (Estimated) 8 July 2030
👥 Enrollment (Estimated) 2510
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Phoenix, Arizona, United States
📍 Little Rock, Arkansas, United States
📍 Loma Linda, California, United States
📍 Long Beach, California, United States
📍 Palo Alto, California, United States
📍 Aurora, Colorado, United States
📍 Bay Pines, Florida, United States
📍 Gainesville, Florida, United States
📍 Tampa, Florida, United States
📍 Decatur, Georgia, United States
📍 Hines, Illinois, United States
📍 Iowa City, Iowa, United States
📍 Lexington, Kentucky, United States
📍 Ann Arbor, Michigan, United States
📍 Minneapolis, Minnesota, United States
📍 Columbia, Missouri, United States
📍 Kansas City, Missouri, United States
📍 Saint Louis, Missouri, United States
📍 Omaha, Nebraska, United States
📍 Albuquerque, New Mexico, United States
📍 Durham, North Carolina, United States
📍 Cincinnati, Ohio, United States
📍 Dayton, Ohio, United States
📍 Portland, Oregon, United States
📍 Philadelphia, Pennsylvania, United States
📍 Columbia, South Carolina, United States
📍 Memphis, Tennessee, United States
📍 Dallas, Texas, United States
📍 Houston, Texas, United States
📍 San Antonio, Texas, United States
📍 Salt Lake City, Utah, United States
📍 Richmond, Virginia, United States
📍 Salem, Virginia, United States
📍 Seattle, Washington, United States
📍 Milwaukee, Wisconsin, United States
More locations available...

📋 Eligibility Criteria

Description

    Inclusion 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, or
      • * Group II: eGFR 30 to less than 45 mL/min/1.73 m2 with UACR \> 30 mg/g or UPCR \> 150 mg/g, or
      • * Group III: eGFR 45 to less than 60 mL/min/1.73 m2 with UACR \> 300 mg/g or UPCR \> 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 \> 30 mg/g, or
      • * Group III: eGFR 45 to less than 60 mL/min/1.73 m2 with UACR \> 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 26 July 2018
  • First Submitted that Met QC Criteria 8 August 2018
  • First Posted 10 August 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 30 April 2024
  • Last Update Posted 1 May 2024
  • Last Verified April 2024
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