Hemodialysis ComplicationNCT05708248
Effect of Pentoxifylline on Anemia in Hemodialysis Patients
A study testing pentoxifylline in people with Hemodialysis Complication, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hemodialysis Complication
- What is being tested?
- pentoxifylline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2023to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both sexes of HD patients
- Age >20 years
- Patients who have adequate hemodialysis for at least 6 months
- Hb level ≤ 10.5 g/dl
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Hospital
Al Mansurah
Hadeer Zakaria, 01067030115, dr.hadeer_2013@yahoo.com
About this study
Official title: Effect of Pentoxifylline on Anemia in Hemodialysis Patients: Role of Hypoxia Inducible Factor-2 Alpha
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.
- Conditions
- Hemodialysis Complication
- Being tested
- pentoxifylline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pentoxifyllineDrug
400 mg pentoxifylline tablets twice daily with meals for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Not described Receives: Drug: pentoxifylline |
| Group II | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in Hemoglobin (Hb) levels
Measured: 6 months
Variation in Hypoxia inducible factor-2 alpha (HIF-2α) levels
Measured: 6 months
Variation in Transforming growth factor β1 (TGF-β1) levels
Measured: 6 months
Variation in erythropoietin stimulating agents' (ESAs) doses
Measured: 6 months
Variation in ESA resistance index (ESA Dose/kg/Week/Hb)
Measured: 6 months
Secondary outcomes (3)
Variation in different inflammatory markers levels
Including levels of C-reactive protein (CRP) and Interleukin 6 (IL-6)
Measured: 6 months
Variation in hepcidin hormone levels
Measured: 6 months
Variation in different parameters for iron status evaluation
Including serum levels of ferritin, iron and total iron binding capacity (TIBC)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study startFeb 2023 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hadeer zakaria, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708248
- Sponsor's protocol ID
- MDP.22.10.111
- Status last verified
- Feb 2023
- First submitted
- 27 Dec 2022
- Last updated
- 6 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zakaria H, Hamdy NA, Sayed-Ahmed NA, El-Mallah A. Pentoxifylline improves anemia through its novel effect on hypoxia-inducible factor-2 alpha in hemodialysis patients: a randomized, double-blind, placebo-controlled clinical trial. Postgrad Med. 2024 Nov;136(8):847-854. doi: 10.1080/00325481.2024.2426448. Epub 2024 Nov 10.
PubMed 39499142
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pentoxifylline on Anemia in Hemodialysis Patients: Role of Hypoxia Inducible Factor-2 Alpha
- ClinicalTrials.gov ID
- NCT05708248
- Acronym / sponsor ID
- MDP.22.10.111
- Conditions
- Hemodialysis Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: pentoxifylline |
| Group II | No intervention | – |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both sexes of HD patients
- Age >20 years
- Patients who have adequate hemodialysis for at least 6 months
- Hb level ≤ 10.5 g/dl
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pentoxifylline400 mg pentoxifylline tablets twice daily with meals for 6 months | Drug | Group I |
Primary outcome
Variation in Hemoglobin (Hb) levels
Time frame: 6 months
Variation in Hypoxia inducible factor-2 alpha (HIF-2α) levels
Time frame: 6 months
Variation in Transforming growth factor β1 (TGF-β1) levels
Time frame: 6 months
Variation in erythropoietin stimulating agents' (ESAs) doses
Time frame: 6 months
Variation in ESA resistance index (ESA Dose/kg/Week/Hb)
Time frame: 6 months
3 secondary outcomes
Variation in different inflammatory markers levels
Time frame: 6 months
Variation in hepcidin hormone levels
Time frame: 6 months
Variation in different parameters for iron status evaluation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Derived from this study: PubMed 39499142Zakaria H, Hamdy NA, Sayed-Ahmed NA, El-Mallah A. Pentoxifylline improves anemia through its novel effect on hypoxia-inducible factor-2 alpha in hemodialysis patients: a randomized, double-blind, placebo-controlled clinical trial. Postgrad Med. 2024 Nov;136(8):847-854. doi: 10.1080/00325481.2024.2426448. Epub 2024 Nov 10.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pentoxifylline in people with Hemodialysis Complication, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hadeer Zakaria (+201067030115, dr.hadeer_2013@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in Hemoglobin (Hb) levels (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05708248, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.