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

Al-Azhar University

Status and phase: Invitation-only; Phase 3

Conditions: Chronic Kidney Diseases

Treatments: Drug: Pentoxifylline 400 MG; Drug: combination of Pentoxifylline 400 MG and Folic Acid; Drug: folic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT05284656

Interventional (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

folic acid Group

Experimental group

Description:

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

Treatment:

Drug: folic acid

Pentoxifylline Group

Experimental group

Description:

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

Treatment:

Drug: Pentoxifylline 400 MG

folic acid and pentoxifylline Group

Experimental group

Description:

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

Treatment:

Drug: combination of Pentoxifylline 400 MG and Folic Acid

control group

No Intervention group

Description:

20 patients will receive their standard therapy only.