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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Walter Reed Army Medical Center
• Collaborator: National Kidney Foundation
• Treatments: Pentoxifylline

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