Pentoxifylline and Progression of Chronic Kidney Disease in Moderate-to-high Risk Patients
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.
|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.|
- Rate of decline in estimated glomerular filtration rate over one year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||January 2006|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
|Experimental: Pentoxifylline||Drug: Pentoxifylline|
|Placebo Comparator: Placebo||Drug: Placebo|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00285298
|Study Director:||Robert M Perkins, MD||Walter Reed Army Medical Center, Nephrology Service|