Hemodialysis Complication
Conditions
Brief summary
The primary goal of this clinical trial is to evaluate the promoting effect of pentoxifylline on anemia correction in hemodialysis patients, and involvement of the hypoxia-inducible factor-2 alpha. While, the secondary aim is to evaluate the effect of pentoxifylline on inflammation, hepcidin and other markers of iron homeostasis in these patients. Participants in this trial will be selected to be age and sex ratio matched and will be randomly assigned into two groups. Patients in group I will receive their regular doses of erythropoietin stimulating agents and other routine treatments plus 400 mg pentoxifylline tablets twice daily with meals for 6 months. While, patients in group II will receive their regular doses of erythropoietin stimulating agents and other routine treatments.
Interventions
DRUGpentoxifylline
400 mg pentoxifylline tablets twice daily with meals for 6 months
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Both sexes of HD patients * Age \>20 years * Patients who have adequate hemodialysis for at least 6 months * Hb level ≤ 10.5 g/dl
Exclusion criteria
* Recently dialyzed patients (less than 6 months) * Patients with known sensitivity to theophylline or other xanthine derivatives * Severe iron deficiency with serum ferritin \< 100 µg/dL and/or TSAT \< 20% * Planning for pregnancy, pregnancy, or lactation * Patients with severe liver disease or other organ failure * Previous renal transplantation, noncompliance with medication or HD prescription, or inability to oral drug administration * Malignancy within last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variation in ESA resistance index (ESA Dose/kg/Week/Hb) | 6 months |
| Variation in Hypoxia inducible factor-2 alpha (HIF-2α) levels | 6 months |
| Variation in Transforming growth factor β1 (TGF-β1) levels | 6 months |
| Variation in erythropoietin stimulating agents' (ESAs) doses | 6 months |
| Variation in Hemoglobin (Hb) levels | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Variation in hepcidin hormone levels | 6 months | — |
| Variation in different parameters for iron status evaluation | 6 months | Including serum levels of ferritin, iron and total iron binding capacity (TIBC) |
| Variation in different inflammatory markers levels | 6 months | Including levels of C-reactive protein (CRP) and Interleukin 6 (IL-6) |
Countries
Egypt
Contacts
Primary ContactHadeer Zakaria
Outcome results
None listed