Anemia RenalEarly Phase 1NCT03800433
Pentoxifylline Administration in Hemodialysis Patients
A Early Phase 1 study testing Trental 400 MG Extended Release Oral Tablet in people with Anemia Renal, run by Ain Shams University.
Trial summary
The aim of the study is to assess the impact of pentoxifylline administration on the modulation of hyporesponsiveness to erythropoietin stimulating agents in hemodialysis patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia Renal
- What is being tested?
- Trental 400 MG Extended Release Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to Apr 2020
- Phase
- Early Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18 years or over).
- Stable hemodialysis >6 months.
- Regular haemodialysis (3 times/ week).
- ESA resistant anemia (Hb <10 mg/dl for 6 mo.).
- ESA dose of >8000 IU/wk.
Who cannot join
- Inadequate hemodialysis.
- Hyperparathyroidism (PTH>800 pg/l).
- Known hypersensitivity to, or intolerance of Pentoxifylline.
- Absolute or functional iron deficiency (ferritin < 100 μg/L and/or transferrin saturation < 20%).
- Presence of systemic haematological disease (including antibody-mediated pure red cell aplasia) or known haemoglobinopathy.
- Major surgery, infection, inflammatory diseases, acute myocardial infarction or malignancy within the last 3 months.
- Patients with chronic liver disease and patients who had received immunosuppressive therapy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Pentoxifylline Administration on the Modulation of Hyporesponsiveness to Erythropoietin Stimulating Agents in Hemodialysis Patients
The aim of the study is to assess the impact of pentoxifylline administration on the modulation of hyporesponsiveness to erythropoietin stimulating agents in hemodialysis patients
Read the detailed description
this is a prospective, randomized, controlled study to assess the impact of pentoxifylline administration on the modulation of hyporesponsiveness to erythropoietin stimulating agents in hemodialysis patients by determining several outcomes from the intervention and control groups at the end of the study.These outcomes include;the difference in hemoglobin and hematocrit concentration , the difference in inflammatory markers tumor necrosis factor Alpha (TNF-α), interleukin-1 Beta (IL-1β),the difference in the dosage of erythropoiesis stimulating agents ,and The erythropoietin stimulating agents (ESA) resistance index (ERI).
- Conditions
- Anemia Renal
- Being tested
- Trental 400 MG Extended Release Oral Tablet
- Keywords
- pentoxifylline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trental 400 MG Extended Release Oral TabletDrug
oral tablets
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | 23 patients will receive their usual dose of erythropoietin stimulating agents and their routine treatment. |
| test | Experimental | 23 patients will receive the intervention drug Pentoxifylline (Trental 400 milligram(MG) Extended Release Oral Tablet) twice daily in addition their usual dose of erythropoietin stimulating agents and their routine treatment. Receives: Drug: Trental 400 MG Extended Release Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in hemoglobin and hematocrit concentration between the intervention and control groups at the end of the study
Patients will be evaluated regularly every month for hemoglobin concentration
Measured: up to 6 months post baseline
safety & tolerability of pentoxifylline ( frequency of adverse drug effects due to Pentoxifylline as well as compliance with pentoxifylline).
Patients will be evaluated regularly for frequency of adverse drug effects due to Pentoxifylline as well as compliance with pentoxifylline
Measured: up to 6 months post baseline
Secondary outcomes (3)
Inflammatory markers TNF-a, IL-1β.
patient will be subjected to laboratory evaluation for estimation of IL-1β,TNF-α levels at baseline as well as end of study evaluation
Measured: up to 6 months post baseline
Difference in the dosage of erythropoiesis stimulating agents.
the dose of ESA will be assessed at end of study evaluation
Measured: up to 6 months post baseline
The ESA ( erythropoiesis stimulating agents)resistance index (ERI).
ERI will be assessed for patients by determining ESA dose and hemoglobin concentration
Measured: up to 6 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study startOct 2019 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Anemia RenalStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Mohamed Elmetwaly, Ain Shams University
- Investigators
- Lamia El Wakeel, Ass.Prof, Study director, Ass.prof clinical pharmacyRadwa El Borolossy, Phd, Study director, Lecturer of clinical pharmacyMagdy ElSharkawy, Prof.Dr., Principal investigator, Prof. of nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800433
- Sponsor's protocol ID
- pentoxifylline in hemodialysis
- Status last verified
- Sep 2019
- First submitted
- 9 Jan 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. doi: 10.1056/NEJMra041809. No abstract available.
PubMed 15758012Johnson DW, Pollock CA, Macdougall IC. Erythropoiesis-stimulating agent hyporesponsiveness. Nephrology (Carlton). 2007 Aug;12(4):321-30. doi: 10.1111/j.1440-1797.2007.00810.x.
PubMed 17635745Cooper A, Mikhail A, Lethbridge MW, Kemeny DM, Macdougall IC. Pentoxifylline improves hemoglobin levels in patients with erythropoietin-resistant anemia in renal failure. J Am Soc Nephrol. 2004 Jul;15(7):1877-82. doi: 10.1097/01.asn.0000131523.17045.56.
PubMed 15213276Ferrari P, Mallon D, Trinder D, Olynyk JK. Pentoxifylline improves haemoglobin and interleukin-6 levels in chronic kidney disease. Nephrology (Carlton). 2010 Apr;15(3):344-9. doi: 10.1111/j.1440-1797.2009.01203.x.
PubMed 20470305Goicoechea M, Garcia de Vinuesa S, Quiroga B, Verdalles U, Barraca D, Yuste C, Panizo N, Verde E, Munoz MA, Luno J. Effects of pentoxifylline on inflammatory parameters in chronic kidney disease patients: a randomized trial. J Nephrol. 2012 Nov-Dec;25(6):969-75. doi: 10.5301/jn.5000077.
PubMed 22241639Ogawa T, Nitta K. Erythropoiesis-stimulating agent hyporesponsiveness in end-stage renal disease patients. Contrib Nephrol. 2015;185:76-86. doi: 10.1159/000380972. Epub 2015 May 19.
PubMed 26023017Shahbazian H, Ghorbani A, Zafar-Mohtashami A, Balali A, AleAli A, Lashkarara GR. Administration of pentoxifylline to improve anemia of hemodialysis patients. J Renal Inj Prev. 2016 Nov 26;6(1):61-64. doi: 10.15171/jrip.2017.11. eCollection 2017.
PubMed 28487874
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pentoxifylline Administration on the Modulation of Hyporesponsiveness to Erythropoietin Stimulating Agents in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03800433
- Acronym / sponsor ID
- pentoxifylline in hemodialysis
- Conditions
- Anemia Renal
- Keywords
- pentoxifylline
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 11 Jan 2019 (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 aim of the study is to assess the impact of pentoxifylline administration on the modulation of hyporesponsiveness to erythropoietin stimulating agents in hemodialysis patients
Detailed description
this is a prospective, randomized, controlled study to assess the impact of pentoxifylline administration on the modulation of hyporesponsiveness to erythropoietin stimulating agents in hemodialysis patients by determining several outcomes from the intervention and control groups at the end of the study.These outcomes include;the difference in hemoglobin and hematocrit concentration , the difference in inflammatory markers tumor necrosis factor Alpha (TNF-α), interleukin-1 Beta (IL-1β),the difference in the dosage of erythropoiesis stimulating agents ,and The erythropoietin stimulating agents (ESA) resistance index (ERI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –23 patients will receive their usual dose of erythropoietin stimulating agents and their routine treatment. |
| test | Experimental | Drug: Trental 400 MG Extended Release Oral Tablet23 patients will receive the intervention drug Pentoxifylline (Trental 400 milligram(MG) Extended Release Oral Tablet) twice daily in addition their usual dose of erythropoietin stimulating agents and their routine treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (18 years or over).
- Stable hemodialysis >6 months.
- Regular haemodialysis (3 times/ week).
- ESA resistant anemia (Hb <10 mg/dl for 6 mo.).
- ESA dose of >8000 IU/wk.
Key exclusion criteria (7 listed)
- Inadequate hemodialysis.
- Hyperparathyroidism (PTH>800 pg/l).
- Known hypersensitivity to, or intolerance of Pentoxifylline.
- Absolute or functional iron deficiency (ferritin < 100 μg/L and/or transferrin saturation < 20%).
- Presence of systemic haematological disease (including antibody-mediated pure red cell aplasia) or known haemoglobinopathy.
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 |
|---|---|---|
| Trental 400 MG Extended Release Oral Tabletoral tablets | Drug | test |
Primary outcome
The difference in hemoglobin and hematocrit concentration between the intervention and control groups at the end of the study
Time frame: up to 6 months post baseline
Patients will be evaluated regularly every month for hemoglobin concentration
safety & tolerability of pentoxifylline ( frequency of adverse drug effects due to Pentoxifylline as well as compliance with pentoxifylline).
Time frame: up to 6 months post baseline
Patients will be evaluated regularly for frequency of adverse drug effects due to Pentoxifylline as well as compliance with pentoxifylline
3 secondary outcomes
Inflammatory markers TNF-a, IL-1β.
Time frame: up to 6 months post baseline
Difference in the dosage of erythropoiesis stimulating agents.
Time frame: up to 6 months post baseline
The ESA ( erythropoiesis stimulating agents)resistance index (ERI).
Time frame: up to 6 months post baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Background: PubMed 15758012Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. doi: 10.1056/NEJMra041809. No abstract available.
- Background: PubMed 17635745Johnson DW, Pollock CA, Macdougall IC. Erythropoiesis-stimulating agent hyporesponsiveness. Nephrology (Carlton). 2007 Aug;12(4):321-30. doi: 10.1111/j.1440-1797.2007.00810.x.
- Background: PubMed 15213276Cooper A, Mikhail A, Lethbridge MW, Kemeny DM, Macdougall IC. Pentoxifylline improves hemoglobin levels in patients with erythropoietin-resistant anemia in renal failure. J Am Soc Nephrol. 2004 Jul;15(7):1877-82. doi: 10.1097/01.asn.0000131523.17045.56.
- Background: PubMed 20470305Ferrari P, Mallon D, Trinder D, Olynyk JK. Pentoxifylline improves haemoglobin and interleukin-6 levels in chronic kidney disease. Nephrology (Carlton). 2010 Apr;15(3):344-9. doi: 10.1111/j.1440-1797.2009.01203.x.
- Background: PubMed 22241639Goicoechea M, Garcia de Vinuesa S, Quiroga B, Verdalles U, Barraca D, Yuste C, Panizo N, Verde E, Munoz MA, Luno J. Effects of pentoxifylline on inflammatory parameters in chronic kidney disease patients: a randomized trial. J Nephrol. 2012 Nov-Dec;25(6):969-75. doi: 10.5301/jn.5000077.
- Background: PubMed 26023017Ogawa T, Nitta K. Erythropoiesis-stimulating agent hyporesponsiveness in end-stage renal disease patients. Contrib Nephrol. 2015;185:76-86. doi: 10.1159/000380972. Epub 2015 May 19.
- Background: PubMed 28487874Shahbazian H, Ghorbani A, Zafar-Mohtashami A, Balali A, AleAli A, Lashkarara GR. Administration of pentoxifylline to improve anemia of hemodialysis patients. J Renal Inj Prev. 2016 Nov 26;6(1):61-64. doi: 10.15171/jrip.2017.11. eCollection 2017.
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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.
Lamia El Wakeel, Ass.Prof study director
Ass.prof clinical pharmacy
Radwa El Borolossy, Phd study director
Lecturer of clinical pharmacy
Magdy ElSharkawy, Prof.Dr. principal investigator
Prof. of nephrology
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Trental 400 MG Extended Release Oral Tablet in people with Anemia Renal, run by Ain Shams University.
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 5 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 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Radwa M Elmetwaly, Bachelor (00201065371016, radwa_mohm@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in hemoglobin and hematocrit concentration between the intervention and control groups at the end of the study (time frame: up to 6 months post baseline). The study lists 2 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 NCT03800433, which also lists 7 linked publications.
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 25 Sep 2019.