Effect of Folic Acid and/or Pentoxifylline on Patients With Chronic Kidney Disease

Study Overview
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Brief Summary
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The aim of this study is to evaluate the effect of administration of folic acid and /or pentoxifylline on patients with chronic kidney disease (CKD).

Detailed Description
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Chronic kidney disease (CKD) is a worldwide public health problem, with adverse outcomes of kidney failure, cardiovascular disease (CVD), and premature death. Chronic kidney disease (CKD) affects between 8% and 16% of the population worldwide.Defined by a glomerular filtration rate (GFR) of less than 60 mL/min/1.73 m2, albuminuria of at least 30 mg per 24 hours, or markers of kidney damage (eg, hematuria or structural abnormalities such as polycystic or dysplastic kidneys) persisting for more than 3 months.That nutrient loss because of diet restriction and chronic inflammation contributed by CKD itself may stimulate progression in advanced chronic kidney disease. Folic acid was then selected as a nutrient intervention. In the mean time, pentoxifylline was well studied in this field for its anti-inflammatory effects.Pentoxifylline (PTF) appears to improve circulation through its ability to alter erythrocyte deformability and enhances capillary microcirculation. This hemorheological property and the potential capacity in decreasing intraglomerular pressure has led to recent interest in PTF as a therapeutic agent in patients with kidney disease. In addition to these properties, PTF has an effect on inflammation, oxidative stress and endothelial function.

Official Title
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The Potential Nephro-protective Effect of Folic Acid and/or Pentoxifylline on Patients With Chronic Kidney Disease

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Drug: combination of Pentoxifylline 400 MG and Folic Acid
* Drug: folic acid
* Drug: Pentoxifylline 400 MG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have chronic kidney disease(CKD) stages 3-5 Aged between18 - 60 years old. Both sexes. Stable clinical condition defined as no hospitalizations or cardiovascular events within the 3 months before screening Stable renal function (baseline serum creatinine had to have not increased by 50% in the 3 months before screening) No changes in concomitant medication during the study. Patients who accept to participate in the study. Exclusion Criteria: Pregnant women 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 Those with active infections or inflammatory diseases or HIV infection Those with chronic liver disease . Patients who had received immunosuppressive therapy Non-compliant patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: folic acid Group<br>20 patients will receive folic acid 500 µg per day with their standard therapy for 6 months. | Drug: folic acid<br>* drugs used to delay progression of chronic kidney disease<br>|
| Experimental: Pentoxifylline Group<br>20 patients will receive Pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months. | Drug: Pentoxifylline 400 MG<br>* drugs used to delay progression of chronic kidney disease<br>* Other names: Trental SR 400mg;|
| Experimental: folic acid and pentoxifylline Group<br>20 patients will receive combination therapy of folic acid5 mg per day and pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months | Drug: combination of Pentoxifylline 400 MG and Folic Acid<br>* drugs used to delay progression of chronic kidney disease<br>* Other names: combination of Trental SR 400mg and Folic acid;|
| No Intervention: control group<br>20 patients will receive their standard therapy only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum creatinine concentration | decrease in serum creatinine concentration in mg/dl from baseline | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum ferritin in ng/ml | increase in serum ferritin from baseline | 6 months | 
| Protein /creatinine ratio | decrease in Protein /creatinine ratio | 6 months |