Efficacy of Pentoxifylline on Chronic Kidney Disease

Study Overview
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Brief Summary
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To study whether pentoxifylline has additive renoprotective effect in patients taking ARB

Detailed Description
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In patients with CKD and serum creatinine 1.3 6.0 md/gl, having taken losartan 100 mg/day for at least 3 months, with stable renal function, will be recruited to a randomized open-label trial. Patients taking pentoxifylline or not will be compared for their spot urinary proteinuria, estimated glomerular filtration, spot urine tumor necrosis factor-α/creatinine ratio, spot urine monocyte-chemoattractant protein-1/creatinine, and aldosterone concentration between groups in a 2-year study. Add-on pentoxifylline in control group in the same dose as in treat group will be performed to observe the renoprotective effect if any protective potential is demonstrated in the end of maintenance 12 months.

Official Title
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Phase 4 Study of the Efficacy of Pentoxifylline in Patients With Chronic Kidney Disease Receiving Angiotensin Receptor Blockade

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Drug: pentoxifylline (drug)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic kidney disease with serum creatinine 1.3 6.0 mg/dl Exclusion Criteria: History of allergy to pentoxifylline Females are nursing or pregnant Obstructive uropathy Unable to stop chronic immunosuppressive therapy, NSAID Congestive heart failure (New York Heart Association functional class III or IV) Unstable angina, myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, within the past 6 months prior to signing the informed consent form Cerebral hemorrhage within the past 6 months prior to signing the informed consent form Retinal hemorrhage within the past 6 months prior to signing the informed consent form Known or suspected secondary hypertension (e.g., primary aldosteronism, renovascular hypertension, pheochromocytoma) Severe uncontrolled hypertension with SBP > 220 mmHg and/or DBP > 115 mmHg Hepatic dysfunction as defined by the following laboratory parameters: ALT or AST > 2 times the upper limit of the normal range Biliary obstructive disorders (e.g. cholestasis) Active malignancy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: pentoxifylline (drug)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spot urinary proteinuria between groups |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| estimated glomerular filtration, spot urine tumor necrosis factor-α/creatinine ratio, spot urine monocyte-chemoattractant protein-1/creatinine, and aldosterone concentration between groups. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD, pentoxifylline