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The potential adding therapeutic effect of pentoxifylline and/or folic acid for chronic kidney disease patients: randomized controlled trial.

  • 2025-08-18
  • BMC nephrology 26(1)
    • Amira Reda Muhammad Galal
    • Nahla Mohamed Teama
    • Karema Abu-Elfotuha
    • Ahmed D Alatawi
    • Hanan Alshareef
    • Ahmed M E Hamdan
    • Ahmed Aljabri
    • Mohannad Alshibani
    • Zeinab AlKasaby Mahmoud Zalat

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 80
Population
80 patients diagnosed with CKD stages 3-5
Methods
randomized, prospective, parallel, and controlled clinical trial; four groups (20 patient/group) receiving standard usual care, PTX, FA, or both; followed up for 6 months
Duration
6 months
Funding
Unclear

Background/objectives

Chronic kidney disease (CKD) is a highly prevalent, irreversible, and progressive disease associated with a high cardiovascular risk. We aimed to clinically investigate the extra-therapeutic effect of adding therapeutic doses of pentoxifylline (PTX) and/or folic acid (FA) for CKD patients to the standard care on their health-related quality.

Methods

A randomized, prospective, parallel, and controlled clinical trial of CONSORT 80 patients diagnosed with CKD stages 3-5 were stratified by simple randomization into four groups (20 patient/group) and followed up for 6 months.

Control group

received standard usual care therapy only; PTX group: received therapeutic dose of PTX added to standard usual care therapy; FA group: received FA added to standard usual care therapy; and PTX and FA group: received both PTX and FA added to their standard usual care therapy. The primary objective was to compare the renal function biochemical parameters for the intervention groups compared to the control group. Meanwhile, the secondary objective was to compare the incidence of readmission to hospitalization with cardiovascular events, incidence of peripheral vascular diseases and Fatigue Assessment Scale (FAS) for the intervention groups compared to the control group.

Clinical trial registration

This study's research was granted authorization by the Research Ethics Committee (REC), Faculty of Medicine, Ain Shams University, No. (FMASU MS UNIV 15/2022) dated to 15/12/2022, and the Ethical Committee in the Faculty of Pharmacy (Girls), Al-Azhar University, No. (313) dated to 22/12/2022. This study was authorized by https://clinicaltrials.gov/ (NCT05284656) and the first date of registration was 16/02/2022. All patients were assigned to write an informed consent.

Results

There was a significant improvement in renal function biochemical parameters and a significant reduction in the FAS for the intervention groups compared to the control group.

Conclusions

Our results demonstrated that administration of therapeutic doses of PTX and/or FA in CKD patients delayed the progression of advanced chronic kidney disease and has been used successfully improved their health-related quality of life.

Research Insights

  • Vitamin B9→Improved Renal Function

    There was a significant improvement in renal function biochemical parameters and a significant reduction in the FAS for the intervention groups compared to the control group.

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    therapeutic dose
  • Vitamin B9→Reduced Fatigue

    There was a significant improvement in renal function biochemical parameters and a significant reduction in the FAS for the intervention groups compared to the control group.

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    therapeutic dose
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