ACTIVE_NOT_RECRUITING

Pentoxifylline in Diabetic Kidney Disease

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Conditions

Diabetic Kidney DiseasepentoxifyllinePTX

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

CSP #2008 - Pentoxifylline in Diabetic Kidney Disease

Quick Facts

Study Start:2019-11-18
Study Completion:2030-07-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03625648

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Type-2 diabetes.
  2. 2. Meet one of the following categories at a time that is greater than 90 days prior to randomization:
  3. * Group I: eGFR 15 to less than 30 mL/min/1.73 m2 regardless of the degree of albuminuria/proteinuria, or
  4. * 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
  5. * 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
  6. 3. Participants need to be in one of the following categories at the time of randomization:
  7. * Group I: eGFR 15 to less than 30 mL/min/1.73 m2, or
  8. * Group II: eGFR 30 to less than 45 mL/min/1.73 m2 with UACR greater than or equal to (\>) 30 mg/g, or
  9. * Group III: eGFR 45 to less than 60 mL/min/1.73 m2 with UACR greater than or equal to (\>) 300 mg/g
  1. 1. Type 1 diabetes
  2. 2. History of non-diabetic kidney disease
  3. 3. Severe comorbid conditions expected to reduce life expectancy to less than 1 year, as determined by LSI
  4. 4. Active substance abuse, homelessness, or other condition that is likely to result in participant non,ompliance as determined by the LSI
  5. 5. Previous organ or bone marrow transplant
  6. 6. Pregnancy, breast feeding or female of child-bearing potential unwilling to use a reliable form of contraception
  7. 7. A recent (within 3 months) cerebral hemorrhage
  8. 8. Current use of oral pentoxifylline
  9. 9. Hypersensitivity to pentoxifylline or any of the components of the formulation
  10. 10. Current use of systemic ketorolac, oral or IV (contraindicated with pentoxifylline)
  11. 11. Current use of riociguat (contraindicated with pentoxifylline)
  12. 12. Current use of dialysis
  13. 13. Unable to provide informed consent
  14. 14. or any condition that in the opinion of the LSI would make the potential participant non-compliant

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, 85012
United States
Central Arkansas Veterans Healthcare System, Little Rock, AR
Little Rock, Arkansas, 72205
United States
VA Loma Linda Healthcare System, Loma Linda, CA
Loma Linda, California, 92357-1000
United States
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, 90822
United States
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
United States
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045
United States
Bay Pines VA Healthcare System, Pay Pines, FL
Bay Pines, Florida, 33744-0000
United States
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608-1135
United States
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612
United States
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033-4004
United States
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030
United States
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, 52246-2292
United States
Lexington VA Medical Center, Lexington, KY
Lexington, Kentucky, 40502-2235
United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
United States
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
United States
Harry S. Truman Memorial, Columbia, MO
Columbia, Missouri, 65201-5275
United States
Kansas City VA Medical Center, Kansas City, MO
Kansas City, Missouri, 64128-2226
United States
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
St Louis, Missouri, 63106-1621
United States
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, 68105-1850
United States
New Mexico VA Health Care System, Albuquerque, NM
Albuquerque, New Mexico, 87108-5153
United States
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
United States
Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, 45220-2213
United States
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97207-2964
United States
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104-4551
United States
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
Columbia, South Carolina, 29209-1638
United States
Memphis VA Medical Center, Memphis, TN
Memphis, Tennessee, 38104-2127
United States
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216-7167
United States
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211
United States
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229-4404
United States
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148-0001
United States
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, 23249-0001
United States
Salem VA Medical Center, Salem, VA
Salem, Virginia, 24153-6404
United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
United States
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin, 53295-0001
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

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

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

Study Start Date2019-11-18
Study Completion Date2030-07-08

Study Record Updates

Study Start Date2019-11-18
Study Completion Date2030-07-08

Terms related to this study

Keywords Provided by Researchers

  • Diabetic Kidney disease
  • pentoxifylline
  • PTX

Additional Relevant MeSH Terms

  • Diabetic Kidney Disease