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

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.