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

NCT ID: NCT05284656

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-08
• Study Completion Date: 2026-12-19

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.

Conditions

Chronic Kidney Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

folic acid Group

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

Group Type: EXPERIMENTAL

folic acid

Intervention Type: DRUG

drugs used to delay progression of chronic kidney disease

Pentoxifylline Group

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

Group Type: EXPERIMENTAL

Pentoxifylline 400 MG

Intervention Type: DRUG

drugs used to delay progression of chronic kidney disease

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

Group Type: EXPERIMENTAL

combination of Pentoxifylline 400 MG and Folic Acid

Intervention Type: DRUG

drugs used to delay progression of chronic kidney disease

control group

20 patients will receive their standard therapy only.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

combination of Pentoxifylline 400 MG and Folic Acid

drugs used to delay progression of chronic kidney disease

Intervention Type: DRUG

folic acid

drugs used to delay progression of chronic kidney disease

Intervention Type: DRUG

Pentoxifylline 400 MG

drugs used to delay progression of chronic kidney disease

Intervention Type: DRUG

Other Intervention Names

combination of Trental SR 400mg and Folic acid; Trental SR 400mg

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Amira Reda Muhammad Galal

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zeinab AlKasaby

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Al Azhar University

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 40826392 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

Interventional

Identifier Type: -

Identifier Source: org_study_id