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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Drug: folic acid; Drug: Pentoxifylline 400 MG; Drug: combination of Pentoxifylline 400 MG and Folic Acid

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Al Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Serum Creatinine Level	Change was calculated as the value at 6 months minus the value at baseline.	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protein/ Creatinine Ratio(P/C) (mg Protein/mg Creatinine)	change in Protein/ creatinine ratio for determination of proteinuria	6 months

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Principal Investigator: Zeinab AlKasaby, Professor and Head of Clinical Pharmacy Department, Faculty of Pharmacy (Girls), Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2022
• Primary Completion (Estimated): June 12, 2026
• Study Completion (Estimated): December 19, 2026

Study Registration Dates

• First Submitted: February 16, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): June 11, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Micronutrients; Antioxidants; Protective Agents; Free Radical Scavengers; Vitamins; Vasodilator Agents; Hematinics; Phosphodiesterase Inhibitors; Radiation-Protective Agents; Folic Acid; Vitamin B Complex; Pentoxifylline
• Other Study ID Numbers: Interventional (Oncolys BioPharma Inc)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No