Pentoxifylline in Diabetic Kidney Disease

Description

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

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Study Overview

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Study Details

Study overview

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.

CSP #2008 - Pentoxifylline in Diabetic Kidney Disease

Pentoxifylline in Diabetic Kidney Disease

Condition
Diabetic Kidney Disease
Intervention / Treatment

-

Contacts and Locations

Phoenix

Phoenix VA Health Care System, Phoenix, AZ, Phoenix, Arizona, United States, 85012

Little Rock

Central Arkansas Veterans Healthcare System, Little Rock, AR, Little Rock, Arkansas, United States, 72205

Loma Linda

VA Loma Linda Healthcare System, Loma Linda, CA, Loma Linda, California, United States, 92357

Long Beach

VA Long Beach Healthcare System, Long Beach, CA, Long Beach, California, United States, 90822

Palo Alto

VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto, California, United States, 94304-1207

Aurora

Rocky Mountain Regional VA Medical Center, Aurora, CO, Aurora, Colorado, United States, 80045

Bay Pines

Bay Pines VA Healthcare System, Pay Pines, FL, Bay Pines, Florida, United States, 33744-0000

Gainesville

North Florida/South Georgia Veterans Health System, Gainesville, FL, Gainesville, Florida, United States, 32608-1135

Tampa

James A. Haley Veterans' Hospital, Tampa, FL, Tampa, Florida, United States, 33612

Decatur

Atlanta VA Medical and Rehab Center, Decatur, GA, Decatur, Georgia, United States, 30033-4004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

VA Office of Research and Development,

David J Leehey, STUDY_CHAIR, Edward Hines Jr. VA Hospital, Hines, IL

Study Record Dates

2030-07-08