CSP #2008 - Pentoxifylline in Diabetic Kidney Disease

Who is this study for? Adult patients with diabetic kidney disease
What treatments are being studied? Pentoxifylline
Status: Recruiting
Location: See all (35) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Type-2 diabetes.

• 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

• 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

∙ Participants must be a United States Veteran, currently receiving care at a VA hospital with a local study team.

Locations
United States
Arkansas
Central Arkansas Veterans Healthcare System, Little Rock, AR
RECRUITING
Little Rock
Arizona
Phoenix VA Health Care System, Phoenix, AZ
RECRUITING
Phoenix
California
VA Loma Linda Healthcare System, Loma Linda, CA
RECRUITING
Loma Linda
VA Long Beach Healthcare System, Long Beach, CA
RECRUITING
Long Beach
VA Palo Alto Health Care System, Palo Alto, CA
RECRUITING
Palo Alto
Colorado
Rocky Mountain Regional VA Medical Center, Aurora, CO
RECRUITING
Aurora
Florida
Bay Pines VA Healthcare System, Pay Pines, FL
RECRUITING
Bay Pines
North Florida/South Georgia Veterans Health System, Gainesville, FL
RECRUITING
Gainesville
James A. Haley Veterans' Hospital, Tampa, FL
RECRUITING
Tampa
Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
RECRUITING
Decatur
Iowa
Iowa City VA Health Care System, Iowa City, IA
RECRUITING
Iowa City
Illinois
Edward Hines Jr. VA Hospital, Hines, IL
RECRUITING
Hines
Kentucky
Lexington VA Medical Center, Lexington, KY
RECRUITING
Lexington
Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
RECRUITING
Ann Arbor
Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
RECRUITING
Minneapolis
Missouri
Harry S. Truman Memorial, Columbia, MO
RECRUITING
Columbia
Kansas City VA Medical Center, Kansas City, MO
RECRUITING
Kansas City
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
RECRUITING
St Louis
North Carolina
Durham VA Medical Center, Durham, NC
RECRUITING
Durham
Nebraska
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
RECRUITING
Omaha
New Mexico
New Mexico VA Health Care System, Albuquerque, NM
RECRUITING
Albuquerque
Ohio
Cincinnati VA Medical Center, Cincinnati, OH
RECRUITING
Cincinnati
Dayton VA Medical Center, Dayton, OH
WITHDRAWN
Dayton
Oregon
VA Portland Health Care System, Portland, OR
RECRUITING
Portland
Pennsylvania
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
RECRUITING
Philadelphia
South Carolina
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
RECRUITING
Columbia
Tennessee
Memphis VA Medical Center, Memphis, TN
RECRUITING
Memphis
Texas
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
RECRUITING
Dallas
Michael E. DeBakey VA Medical Center, Houston, TX
RECRUITING
Houston
South Texas Health Care System, San Antonio, TX
RECRUITING
San Antonio
Utah
VA Salt Lake City Health Care System, Salt Lake City, UT
RECRUITING
Salt Lake City
Virginia
Hunter Holmes McGuire VA Medical Center, Richmond, VA
RECRUITING
Richmond
Salem VA Medical Center, Salem, VA
RECRUITING
Salem
Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
RECRUITING
Seattle
Wisconsin
Clement J. Zablocki VA Medical Center, Milwaukee, WI
RECRUITING
Milwaukee
Contact Information
Primary
Douglas E Lammie, MPH RD
douglas.lammie@va.gov
(708) 202-8387
Backup
Cheryl C Odle, MBA
cheryl.odle@va.gov
(708) 202-8387
Time Frame
Start Date: 2019-11-18
Estimated Completion Date: 2030-07-08
Participants
Target number of participants: 2510
Treatments
Experimental: PTX
Active drug
Placebo_comparator: Placebo
Placebo
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov

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