Status:
COMPLETED
Pentoxifylline and Progression of Chronic Kidney Disease in Moderate-to-high Risk Patients
Lead Sponsor:
Walter Reed Army Medical Center
Collaborating Sponsors:
National Kidney Foundation, United States
Conditions:
Kidney Failure, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 progress...
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00285298
Start Date
January 1 2006
End Date
April 1 2008
Last Update
July 29 2011
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