Clinical trial NCT03800433: Pentoxifylline Administration in Hemodialysis Patients
Official title: Impact of Pentoxifylline Administration on the Modulation of Hyporesponsiveness to Erythropoietin Stimulating Agents in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Anemia Renal
Keywords: pentoxifylline
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The difference in hemoglobin and hematocrit concentration between the intervention and control groups at the end of the study
timeFrame: up to 6 months post baseline
measure: safety & tolerability of pentoxifylline ( frequency of adverse drug effects due to Pentoxifylline as well as compliance with pentoxifylline).
timeFrame: up to 6 months post baseline
Secondary outcomes:
measure: Inflammatory markers TNF-a, IL-1β.
timeFrame: up to 6 months post baseline
measure: Difference in the dosage of erythropoiesis stimulating agents.
timeFrame: up to 6 months post baseline
measure: The ESA ( erythropoiesis stimulating agents)resistance index (ERI).
timeFrame: up to 6 months post baseline
Other outcomes:
Locations:
Study officials:
affiliation: Ass.prof clinical pharmacy
name: Lamia El Wakeel, Ass.Prof
role: STUDY_DIRECTOR
affiliation: Lecturer of clinical pharmacy
name: Radwa El Borolossy, Phd
role: STUDY_DIRECTOR
affiliation: Prof. of nephrology
name: Magdy ElSharkawy, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Johnson 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.
citation: Cooper 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.
citation: Ferrari 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.
citation: Goicoechea 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.
citation: Ogawa 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.
citation: Shahbazian 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.