Clinical trial NCT05284656: Effect of Folic Acid and/or Pentoxifylline on Patients With Chronic Kidney Disease
Official title: The Potential Nephro-protective Effect of Folic Acid and/or Pentoxifylline on Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Chronic Kidney Diseases
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Serum Creatinine Level
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Serum Ferritin in ng/ml
timeFrame: 6 months
Other outcomes:
measure: Protein/ Creatinine Ratio(P/C) (mg Protein/mg Creatinine)
timeFrame: 6 months
Locations:
city: Cairo
country: Egypt
facility: Al Azhar University
Study officials:
affiliation: Professor and Head of Clinical Pharmacy Department, Faculty of Pharmacy (Girls), Al-Azhar University
name: Zeinab AlKasaby
role: PRINCIPAL_INVESTIGATOR
References: