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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00285298
Recruitment Status : Completed
First Posted : February 1, 2006
Last Update Posted : July 29, 2011
National Kidney Foundation
Information provided by:
Walter Reed Army Medical Center

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.

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Drug: Pentoxifylline Drug: Placebo Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pentoxifylline and Progression of Chronic Kidney Disease in Moderate-to-high Risk Patients: a Pilot Randomized, Placebo-controlled, Double-blind Trial.
Study Start Date : January 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Pentoxifylline Drug: Pentoxifylline
Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. Rate of decline in estimated glomerular filtration rate over one year [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 50% reduction in proteinuria [ Time Frame: 1 year ]
  2. Change in slope of 1/serum creatinine vs time [ Time Frame: 1 year ]

Information from the National Library of Medicine

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

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:

  1. 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.


  2. Nephrotic range proteinuria (>=3 grams/day proteinuria) by 24-hr urine collection, and an eGFR greater than 20 ml/minute

Exclusion Criteria:

  1. Acute renal failure: defined by >25% decrease in eGFR over one month
  2. Pregnancy or currently breast-feeding
  3. Current use of cytotoxic drug therapy (cyclophosphamide, cyclosporine, mycophenolate mofetil, prednisone, chlorambucil) or a current indication for, and plan to implement, such therapy.
  4. Current use of PTF
  5. Contraindication to use of PTF drug: history of PTF or theophylline allergy, history of severe retinal hemorrhage or recent cerebral hemorrhage
  6. Current use of theophylline
  7. Contraindication to ACE-I or ARB.
  8. Fewer than 2 measured serum creatinine values separated by 6 months prior to potential enrollment

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 identifier (NCT number): NCT00285298

Sponsors and Collaborators
Walter Reed Army Medical Center
National Kidney Foundation
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Study Director: Robert M Perkins, MD Walter Reed Army Medical Center, Nephrology Service
Publications of Results:
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Responsible Party: Robert M. Perkins, MD, Geisinger Medical Center Identifier: NCT00285298    
Other Study ID Numbers: 05-11010(1)
11010A (NKF)
First Posted: February 1, 2006    Key Record Dates
Last Update Posted: July 29, 2011
Last Verified: September 2009
Keywords provided by Walter Reed Army Medical Center:
Kidney failure, chronic
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases
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