Chronic Kidney Diseases
Conditions
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.
Interventions
DRUGcombination of Pentoxifylline 400 MG and Folic Acid
drugs used to delay progression of chronic kidney disease
DRUGfolic acid
drugs used to delay progression of chronic kidney disease
drugs used to delay progression of chronic kidney disease
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Creatinine Level | Baseline, 6 months | Change was calculated as the value at 6 months minus the value at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Ferritin in ng/ml | 6 months | increase in serum ferritin from baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Protein/ Creatinine Ratio(P/C) (mg Protein/mg Creatinine) | 6 months | change in Protein/ creatinine ratio for determination of proteinuria |
Countries
Egypt
Participant flow
Pre-assignment details
some patient are excluded from the study as they donnot meet the inclusion criteria
Participants by arm
| Arm | Count |
|---|---|
| Folic Acid Group 20 patients will receive folic acid 500 µg per day with their standard therapy for 6 months.
folic acid: drugs used to delay progression of chronic kidney disease | 20 |
| Folic Acid and Pentoxifylline Group 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
combination of Pentoxifylline 400 MG and Folic Acid: drugs used to delay progression of chronic kidney disease | 20 |
| Pentoxifylline Group 20 patients will receive Pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months.
Pentoxifylline 400 MG: drugs used to delay progression of chronic kidney disease | 20 |
| Control Group 20 patients will receive their standard therapy only. | 20 |
| Total | 80 |
Baseline characteristics
| Characteristic | Folic Acid Group | Folic Acid and Pentoxifylline Group | Pentoxifylline Group | Control Group | Total |
|---|---|---|---|---|---|
| Age, Continuous | 52.25 years STANDARD_DEVIATION 6.64 | 51.80 years STANDARD_DEVIATION 6.7 | 52.20 years STANDARD_DEVIATION 7.2 | 51.6 years STANDARD_DEVIATION 6.6 | 51.96 years STANDARD_DEVIATION 6.78 |
| glomular filtration rate | 22.15 ml/min STANDARD_DEVIATION 11.12 | 17.25 ml/min STANDARD_DEVIATION 7.217 | 17.85 ml/min STANDARD_DEVIATION 8.6 | 21.87 ml/min STANDARD_DEVIATION 9.7 | 19.78 ml/min STANDARD_DEVIATION 9.15 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 10 Participants | 12 Participants | 53 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 10 Participants | 8 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Change in Serum Creatinine Level
Change was calculated as the value at 6 months minus the value at baseline.
Time frame: Baseline, 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Folic Acid Group | Change in Serum Creatinine Level | 3.118 mg/dl | Standard Deviation 1.203 |
| Pentoxifylline Group | Change in Serum Creatinine Level | 3.335 mg/dl | Standard Deviation 1.149 |
| Folic Acid and Pentoxifylline Group | Change in Serum Creatinine Level | 3.535 mg/dl | Standard Deviation 0.9109 |
| Control Group | Change in Serum Creatinine Level | 2.872 mg/dl | Standard Deviation 0.8901 |
Secondary
Serum Ferritin in ng/ml
increase in serum ferritin from baseline
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Folic Acid Group | Serum Ferritin in ng/ml | 200.6 ng/ml | Standard Deviation 66.18 |
| Pentoxifylline Group | Serum Ferritin in ng/ml | 334.1 ng/ml | Standard Deviation 230.2 |
| Folic Acid and Pentoxifylline Group | Serum Ferritin in ng/ml | 245.1 ng/ml | Standard Deviation 115.7 |
| Control Group | Serum Ferritin in ng/ml | 235.3 ng/ml | Standard Deviation 185.1 |
Other Pre-specified
Protein/ Creatinine Ratio(P/C) (mg Protein/mg Creatinine)
change in Protein/ creatinine ratio for determination of proteinuria
Time frame: 6 months