Pentoxifylline Administration in Hemodialysis Patients

NCT03800433 | Unknown Early Phase 1

• 1 other identifier: pentoxifylline in hemodialysis
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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

Conditions

Anemia Renal

Keywords

pentoxifylline

Outcome Measures

Primary Outcomes (2)

• 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

  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

  up to 6 months post baseline

Secondary Outcomes (3)

• Inflammatory markers TNF-a, IL-1β.

  up to 6 months post baseline

• Difference in the dosage of erythropoiesis stimulating agents.

  up to 6 months post baseline

• The ESA ( erythropoiesis stimulating agents)resistance index (ERI).

  up to 6 months post baseline

Study Arms (2)

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.

Drug: Trental 400 MG Extended Release Oral Tablet

Interventions

Trental 400 MG Extended Release Oral Tablet DRUG

oral tablets

test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (7)

• 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.

  PMID: 15758012 BACKGROUND

• 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.

  PMID: 17635745 BACKGROUND

• 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.

  PMID: 15213276 BACKGROUND

• 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.

  PMID: 20470305 BACKGROUND

• 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.

  PMID: 22241639 BACKGROUND

• 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.

  PMID: 26023017 BACKGROUND

• 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.

  PMID: 28487874 BACKGROUND

MeSH Terms

Interventions

Pentoxifylline

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Lamia El Wakeel, Ass.Prof

  Ass.prof clinical pharmacy

  STUDY DIRECTOR

• Radwa El Borolossy, Phd

  Lecturer of clinical pharmacy

  STUDY DIRECTOR

• Magdy ElSharkawy, Prof.Dr.

  Prof. of nephrology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Radwa M Elmetwaly, Bachelor

CONTACT

00201065371016; radwa_mohm@yahoo.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post grad

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 11, 2019
• Study Start: October 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: September 25, 2019

Record last verified: 2019-09