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Pentoxifylline and Progression of Chronic Kidney Disease in Moderate-to-high Risk Patients

Primary Purpose

Kidney Failure, Chronic

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Pentoxifylline
Placebo
Sponsored by
Walter Reed Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure, Chronic focused on measuring proteinuria, Kidney failure, chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients 18 years of age or older currently being treated with an ACE-I or ARB and with one of the following conditions: Non-nephrotic range proteinuria (between 1 and 3 grams/day by 24-hr collection), hypertension (blood pressure >130/80 or current use of antihypertensive drug therapy), and an eGFR of less than or equal to 40 ml/minute but greater than 20 ml/minute. OR Nephrotic range proteinuria (>=3 grams/day proteinuria) by 24-hr urine collection, and an eGFR greater than 20 ml/minute Exclusion Criteria: Acute renal failure: defined by >25% decrease in eGFR over one month Pregnancy or currently breast-feeding Current use of cytotoxic drug therapy (cyclophosphamide, cyclosporine, mycophenolate mofetil, prednisone, chlorambucil) or a current indication for, and plan to implement, such therapy. Current use of PTF Contraindication to use of PTF drug: history of PTF or theophylline allergy, history of severe retinal hemorrhage or recent cerebral hemorrhage Current use of theophylline Contraindication to ACE-I or ARB. Fewer than 2 measured serum creatinine values separated by 6 months prior to potential enrollment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Pentoxifylline

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Rate of decline in estimated glomerular filtration rate over one year

    Secondary Outcome Measures

    50% reduction in proteinuria
    Change in slope of 1/serum creatinine vs time

    Full Information

    First Posted
    January 31, 2006
    Last Updated
    July 28, 2011
    Sponsor
    Walter Reed Army Medical Center
    Collaborators
    National Kidney Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00285298
    Brief Title
    Pentoxifylline and Progression of Chronic Kidney Disease in Moderate-to-high Risk Patients
    Official Title
    Pentoxifylline and Progression of Chronic Kidney Disease in Moderate-to-high Risk Patients: a Pilot Randomized, Placebo-controlled, Double-blind Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    April 2008 (Actual)
    Study Completion Date
    April 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Walter Reed Army Medical Center
    Collaborators
    National Kidney Foundation

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of the investigators study is to assess the impact of therapy with Pentoxifylline (PTF), a nonspecific phosphodiesterase inhibitor, on kidney function in patients at high-risk for progression to end-stage renal disease. The investigators hypothesize that therapy with Pentoxifylline will slow progression of kidney disease over time.
    Detailed Description
    The treatment objective for chronic kidney disease (CKD), regardless of etiology, is to slow or halt progression of renal dysfunction and reduce proteinuria (in those patients with proteinuric renal disease). Multi-drug medical regimens remain the cornerstone of therapy for medical-renal disease, often with an angiotensin converting enzyme inhibitor and/or an angiotensin receptor blocker. These therapies, though often efficacious, have not been shown to halt disease progression entirely, and the medical therapy of renal disease remains suboptimal. PTF is a safe, generally well-tolerated drug currently indicated for symptomatic and functional relief of intermittent claudication presumed due to chronic occlusive arterial disease of the limbs. A number of small studies in patients across a range of renal disease states show that PTF can reduce proteinuria, an important component of treatment of CKD. It is not known, however, if the drug will slow progression of CKD as measured by glomerular filtration rate. Comparisons: subjects randomized to receive PTF compared with those randomized to receive placebo

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kidney Failure, Chronic
    Keywords
    proteinuria, Kidney failure, chronic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    39 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pentoxifylline
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Pentoxifylline
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Rate of decline in estimated glomerular filtration rate over one year
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    50% reduction in proteinuria
    Time Frame
    1 year
    Title
    Change in slope of 1/serum creatinine vs time
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients 18 years of age or older currently being treated with an ACE-I or ARB and with one of the following conditions: Non-nephrotic range proteinuria (between 1 and 3 grams/day by 24-hr collection), hypertension (blood pressure >130/80 or current use of antihypertensive drug therapy), and an eGFR of less than or equal to 40 ml/minute but greater than 20 ml/minute. OR Nephrotic range proteinuria (>=3 grams/day proteinuria) by 24-hr urine collection, and an eGFR greater than 20 ml/minute Exclusion Criteria: Acute renal failure: defined by >25% decrease in eGFR over one month Pregnancy or currently breast-feeding Current use of cytotoxic drug therapy (cyclophosphamide, cyclosporine, mycophenolate mofetil, prednisone, chlorambucil) or a current indication for, and plan to implement, such therapy. Current use of PTF Contraindication to use of PTF drug: history of PTF or theophylline allergy, history of severe retinal hemorrhage or recent cerebral hemorrhage Current use of theophylline Contraindication to ACE-I or ARB. Fewer than 2 measured serum creatinine values separated by 6 months prior to potential enrollment
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert M Perkins, MD
    Organizational Affiliation
    Walter Reed Army Medical Center, Nephrology Service
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19216016
    Citation
    Perkins RM, Aboudara MC, Uy AL, Olson SW, Cushner HM, Yuan CM. Effect of pentoxifylline on GFR decline in CKD: a pilot, double-blind, randomized, placebo-controlled trial. Am J Kidney Dis. 2009 Apr;53(4):606-16. doi: 10.1053/j.ajkd.2008.11.026. Epub 2009 Feb 12.
    Results Reference
    result

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    Pentoxifylline and Progression of Chronic Kidney Disease in Moderate-to-high Risk Patients

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