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

Phase 3Active Not RecruitingNCT05284656

Al-Azhar University80 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Chronic Kidney Diseases

Interventions

combination of Pentoxifylline 400 MG and Folic AcidDRUG

drugs used to delay progression of chronic kidney disease

folic acidDRUG

drugs used to delay progression of chronic kidney disease

Pentoxifylline 400 MGDRUG

drugs used to delay progression of chronic kidney disease

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients who have chronic kidney disease(CKD) stages 3-5 2. Aged between18 - 60 years old. 3. Both sexes. 4. Stable clinical condition defined as no hospitalizations or cardiovascular events within the 3 months before screening 5. Stable renal function (baseline serum creatinine had to have not increased by 50% in the 3 months before screening) 6. No changes in concomitant medication during the study. 7. Patients who accept to participate in the study. Exclusion Criteria: 1. Pregnant women 2. Current use of PTF 3. Contraindication to use of PTF drug: history of PTF or theophylline allergy, history of severe retinal hemorrhage or recent cerebral hemorrhage 4. Those with active infections or inflammatory diseases or HIV infection 5. Those with chronic liver disease . 6. Patients who had received immunosuppressive therapy 7. Non-compliant patients

Locations (1)

Al Azhar University

Cairo, Egypt

Outcomes

Primary Outcomes

Change in Serum Creatinine Level

Change was calculated as the value at 6 months minus the value at baseline.

Time frame: Baseline, 6 months

Secondary Outcomes

Serum Ferritin in ng/ml

increase in serum ferritin from baseline

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.