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

This study has been completed.
Sponsor:
Collaborator:
National Kidney Foundation
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00285298
First received: January 31, 2006
Last updated: July 28, 2011
Last verified: September 2009
History of Changes
  Purpose

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 Intervention Phase
Kidney Failure, Chronic
 Drug: Pentoxifylline
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:
  • Rate of decline in estimated glomerular filtration rate over one year [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 50% reduction in proteinuria [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change in slope of 1/serum creatinine vs time [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: January 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pentoxifylline Drug: Pentoxifylline
Placebo Comparator: Placebo Drug: Placebo

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  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.

    OR

  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00285298

Sponsors and Collaborators
Walter Reed Army Medical Center
National Kidney Foundation
Investigators
Study Director: Robert M Perkins, MD Walter Reed Army Medical Center, Nephrology Service
  More Information

Publications:

Responsible Party: Robert M. Perkins, MD, Geisinger Medical Center
ClinicalTrials.gov Identifier: NCT00285298     History of Changes
Other Study ID Numbers: 05-11010(1), 11010A (NKF)
Study First Received: January 31, 2006
Last Updated: July 28, 2011
Health Authority: United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:
proteinuria
Kidney failure, chronic

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Pentoxifylline
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Cardiovascular Agents
Free Radical Scavengers
Antioxidants

ClinicalTrials.gov processed this record on May 22, 2013