Effect of Folic Acid and/or Pentoxifylline on Patients With Chronic Kidney Disease
- Conditions
- Chronic Kidney Diseases
- Interventions
- Registration Number
- NCT05284656
- Lead Sponsor
- Al-Azhar University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description folic acid Group folic acid 20 patients will receive folic acid 500 µg per day with their standard therapy for 6 months. Pentoxifylline Group Pentoxifylline 400 MG 20 patients will receive Pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months. folic acid and pentoxifylline Group combination of Pentoxifylline 400 MG and Folic Acid 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
- Primary Outcome Measures
Name Time Method Change in serum creatinine concentration 6 months decrease in serum creatinine concentration in mg/dl from baseline
- Secondary Outcome Measures
Name Time Method serum ferritin in ng/ml 6 months increase in serum ferritin from baseline
Protein /creatinine ratio 6 months decrease in Protein /creatinine ratio
Trial Locations
- Locations (1)
Al Azhar University
🇪🇬Cairo, Egypt