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Pentoxifylline in Diabetic Kidney Disease (PTXRx)

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ClinicalTrials.gov Identifier: NCT03625648
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : September 24, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetic Kidney Disease Drug: Pentoxifylline Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, placebo controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CSP #2008 - Pentoxifylline in Diabetic Kidney Disease
Actual Study Start Date : November 18, 2019
Estimated Primary Completion Date : January 3, 2028
Estimated Study Completion Date : July 8, 2030

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PTX
Active drug
Drug: Pentoxifylline
The non-specific phosphodiesterase inhibitor pentoxifylline (PTX) was approved by the FDA in 1984 for the treatment of peripheral vascular disease.

Placebo Comparator: Placebo
Placebo
Drug: Placebo
placebo




Primary Outcome Measures :
  1. Time to ESRD or death [ Time Frame: 5 to 9 years ]
    ESRD will be defined as need for chronic dialysis or renal transplantation.


Secondary Outcome Measures :
  1. Quality of life (KDQoL-SF) [ Time Frame: 5 to 9 years ]
    Quality of life as measured by the Kidney Disease Quality of Life Short Form (KDQoL-SF)

  2. Time until doubling of serum creatinine [ Time Frame: 5 to 9 years ]
    Time until doubling of serum creatinine

  3. Incidence of congestive heart failure hospitalization (CHF) [ Time Frame: 5 to 9 years ]
    The risk of a CHF hospitalization will be based on the participant-time data, specifically, the number of events per years.

  4. Incidence of a three-point MACE [ Time Frame: 5 to 9 years ]
    The risk of a MACE event will be based on participant-time data, specifically, the number of events per participant years.

  5. Incidence of a peripheral vascular disease (PVD) [ Time Frame: 5 to 9 years ]
    The risk of a PVD event will be based on participant-time data, specifically, the number of events per participant years.

  6. Percentage of participants with 50% reduction in UACR from baseline [ Time Frame: 5 to 9 years ]
    Percentage of participants with 50% reduction in UACR from baseline

  7. Rate of change in eGFR per year during the study period [ Time Frame: 5 to 9 years ]
    Rate of change in eGFR per year during the study period.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type-2 diabetes
  • Chronic Kidney Disease, stage 3 or 4 (eGFR 15-60 mL/min/1.73 m2) at the time of randomization and on one or more occasions 3 months or more prior to randomization
  • Participants need to be in one of the following categories at the time of randomization and on one or more occasions 3 months or more prior to randomization:

    • eGFR 15 to less than 30 mL/min/1.73 m2, or
    • eGFR 30 to less than 45 mL/min/1.73 m2 with UACR > 30 mg/g*, or
    • eGFR 45 to less than 60 mL/min/1.73 m2 with UACR > 300 mg/g**
    • *For screening purposes only, UPCR > 150 mg/g acceptable.
    • **For screening purposes only, UPCR > 500 mg/g acceptable.

Exclusion Criteria:

  • Type 1 diabetes
  • Known non-diabetic kidney disease
  • Severe comorbid conditions (expected to reduce life expectancy to less than 1 year, as determined by LSI)
  • Previous organ or bone marrow transplant
  • Pregnancy, breast feeding or females of child-bearing potential who are unwilling to use a reliable form of contraception
  • Presence of recent (within 3 months) cerebral hemorrhage
  • Currently using oral PTX
  • Hypersensitivity to PTX or any of the components of the formulation
  • Current use of ketorolac (contraindicated with PTX )
  • Current use of riociguat (contraindicated with PTX)
  • Unable to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03625648


Contacts
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Contact: Douglas E Lammie, MPH RD (708) 202-8387 ext 25746 douglas.lammie@va.gov
Contact: Nicholas Emanuele, MD (708) 202-5785 nicholas.emanuele@va.gov

Locations
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United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA Recruiting
Decatur, Georgia, United States, 30033
Contact: Lawrence Phillips, MD    404-321-6111 ext 6839    Lawrence.Phillips@va.gov   
Contact: Patricia Maya, RN    404321611 ext 203120    patricia.maya@va.gov   
United States, Illinois
Edward Hines Jr. VA Hospital, Hines, IL Recruiting
Hines, Illinois, United States, 60141-5000
Contact: David J Leehey    708-202-8387 ext 22781    David.Leehey@va.gov   
Study Chair: David J Leehey         
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Scott Reule, MD    651-402-4881    scott.reule@va.gov   
Contact: David M Leverty, MPH    6127252000 ext 331027    David.Leverty@va.gov   
United States, Nebraska
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE Recruiting
Omaha, Nebraska, United States, 68105-1873
Contact: Robert J Anderson, MD    402-995-4312    robert.anderson4@va.gov   
Contact: Moira Neal, RN    (402) 9954045    Moira.neal@va.gov   
United States, Virginia
Hunter Holmes McGuire VA Medical Center, Richmond, VA Recruiting
Richmond, Virginia, United States, 23249
Contact: Sonja Fredrickson, MD    804-675-5535    Sonja.Fredrickson@va.gov   
Contact: Roberta M Wachur, RN    8046755363    roberta.wachur@va.gov   
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA Active, not recruiting
Seattle, Washington, United States, 98108
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Study Chair: David J Leehey Edward Hines Jr. VA Hospital, Hines, IL
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03625648    
Other Study ID Numbers: 2008
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: September 24, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by VA Office of Research and Development:
Diabetic Kidney disease
pentoxifylline
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pentoxifylline
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers
Antioxidants