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

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05284656
• Other study ID #: Interventional
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: January 8, 2022
• Est. completion date: April 2023

Study information

• Verified date: January 2023
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: April 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• combination of Pentoxifylline 400 MG and Folic Acid
drugs used to delay progression of chronic kidney disease
• folic acid
drugs used to delay progression of chronic kidney disease
• Pentoxifylline 400 MG
drugs used to delay progression of chronic kidney disease

Locations

Country	Name	City	State
Egypt	Al Azhar University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum creatinine concentration	decrease in serum creatinine concentration in mg/dl from baseline	6 months
Secondary	serum ferritin in ng/ml	increase in serum ferritin from baseline	6 months
Secondary	Protein /creatinine ratio	decrease in Protein /creatinine ratio	6 months