Effect of Folic Acid and/or Pentoxifylline on Patients With Chronic Kidney Disease
Primary Purpose
Chronic Kidney Diseases
Status
Enrolling by invitation
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
combination of Pentoxifylline 400 MG and Folic Acid
folic acid
Pentoxifylline 400 MG
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Kidney Diseases
Eligibility Criteria
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
Sites / Locations
- Al Azhar University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
folic acid Group
Pentoxifylline Group
folic acid and pentoxifylline Group
control group
Arm Description
20 patients will receive folic acid 500 µg per day with their standard therapy for 6 months.
20 patients will receive Pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months.
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
20 patients will receive their standard therapy only.
Outcomes
Primary Outcome Measures
Change in serum creatinine concentration
decrease in serum creatinine concentration in mg/dl from baseline
Secondary Outcome Measures
serum ferritin in ng/ml
increase in serum ferritin from baseline
Protein /creatinine ratio
decrease in Protein /creatinine ratio
Full Information
NCT ID
NCT05284656
First Posted
February 16, 2022
Last Updated
January 31, 2023
Sponsor
Al-Azhar University
1. Study Identification
Unique Protocol Identification Number
NCT05284656
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 8, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
folic acid Group
Arm Type
Experimental
Arm Description
20 patients will receive folic acid 500 µg per day with their standard therapy for 6 months.
Arm Title
Pentoxifylline Group
Arm Type
Experimental
Arm Description
20 patients will receive Pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months.
Arm Title
folic acid and pentoxifylline Group
Arm Type
Experimental
Arm 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
Arm Title
control group
Arm Type
No Intervention
Arm Description
20 patients will receive their standard therapy only.
Intervention Type
Drug
Intervention Name(s)
combination of Pentoxifylline 400 MG and Folic Acid
Other Intervention Name(s)
combination of Trental SR 400mg and Folic acid
Intervention Description
drugs used to delay progression of chronic kidney disease
Intervention Type
Drug
Intervention Name(s)
folic acid
Intervention Description
drugs used to delay progression of chronic kidney disease
Intervention Type
Drug
Intervention Name(s)
Pentoxifylline 400 MG
Other Intervention Name(s)
Trental SR 400mg
Intervention Description
drugs used to delay progression of chronic kidney disease
Primary Outcome Measure Information:
Title
Change in serum creatinine concentration
Description
decrease in serum creatinine concentration in mg/dl from baseline
Time Frame
6 months
Secondary Outcome Measure Information:
Title
serum ferritin in ng/ml
Description
increase in serum ferritin from baseline
Time Frame
6 months
Title
Protein /creatinine ratio
Description
decrease in Protein /creatinine ratio
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeinab AlKasaby
Organizational Affiliation
Professor and Head of Clinical Pharmacy Department, Faculty of Pharmacy (Girls), Al-Azhar University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al Azhar University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Folic Acid and/or Pentoxifylline on Patients With Chronic Kidney Disease
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