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OpenTrials
Active, Not Recruiting

NCT Number: NCT05284656

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

combination of Pentoxifylline 400 MG and Folic Acid

Drug

drugs used to delay progression of chronic kidney disease

Other names: combination of Trental SR 400mg and Folic acid

Folic Acid

Drug

drugs used to delay progression of chronic kidney disease

Pentoxifylline 400 MG

Drug

drugs used to delay progression of chronic kidney disease

Other names: Trental SR 400mg

Primary outcomes

  1. Change in Serum Creatinine Level

    Time frame: Baseline, 6 months

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

Secondary outcomes

  1. Serum Ferritin in ng/ml

    Time frame: 6 months

    increase in serum ferritin from baseline

Other outcomes

  1. Protein/ Creatinine Ratio(P/C) (mg Protein/mg Creatinine)

    Time frame: 6 months

    change in Protein/ creatinine ratio for determination of proteinuria

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 17, 2022
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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