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

NCT05284656 | Active Not Recruiting Phase 3 Results

• 1 other identifier: Interventional
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Change in Serum Creatinine Level

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

  Baseline, 6 months

Secondary Outcomes (1)

• Serum Ferritin in ng/ml

  6 months

Other Outcomes (1)

• Protein/ Creatinine Ratio(P/C) (mg Protein/mg Creatinine)

  6 months

Study Arms (4)

folic acid Group

EXPERIMENTAL

20 patients will receive folic acid 500 µg per day with their standard therapy for 6 months.

Drug: folic acid

Pentoxifylline Group

EXPERIMENTAL

20 patients will receive Pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months.

Drug: Pentoxifylline 400 MG

folic acid and pentoxifylline Group

EXPERIMENTAL

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

control group

NO INTERVENTION

20 patients will receive their standard therapy only.

Interventions

combination of Pentoxifylline 400 MG and Folic Acid DRUG

drugs used to delay progression of chronic kidney disease

Also known as: combination of Trental SR 400mg and Folic acid

folic acid and pentoxifylline Group

folic acid DRUG

drugs used to delay progression of chronic kidney disease

folic acid Group

Pentoxifylline 400 MG DRUG

drugs used to delay progression of chronic kidney disease

Also known as: Trental SR 400mg

Pentoxifylline Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al Azhar University

Cairo, Egypt

Location

Related Publications (1)

• Galal ARM, Teama NM, Abu-Elfotuha K, Alatawi AD, Alshareef H, Hamdan AME, Aljabri A, Alshibani M, Zalat ZAM. The potential adding therapeutic effect of pentoxifylline and/or folic acid for chronic kidney disease patients: randomized controlled trial. BMC Nephrol. 2025 Aug 18;26(1):468. doi: 10.1186/s12882-025-04399-3.

  PMID: 40826392 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Folic Acid; Pentoxifylline

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Theobromine; Xanthines; Purinones; Purines

Results Point of Contact

• Title: Amira Reda Muhammad
• Organization: Al-Azhar University

amira.reda89@hotmail.com

0106 822 0389

Study Officials

• Zeinab AlKasaby

  Professor and Head of Clinical Pharmacy Department, Faculty of Pharmacy (Girls), Al-Azhar University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: March 17, 2022
• Study Start: January 8, 2022
• Primary Completion (Estimated): June 12, 2026
• Study Completion (Estimated): December 19, 2026
• Last Updated: June 11, 2025
• Results First Posted: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)