Pentoxifylline Administration in Hemodialysis Patients

Anemia Renal Clinical Trial

Official title:

Impact of Pentoxifylline Administration on the Modulation of Hyporesponsiveness to Erythropoietin Stimulating Agents in Hemodialysis Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03800433
• Other study ID #: pentoxifylline in hemodialysis
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: October 2019
• Est. completion date: April 2020

Study information

• Verified date: September 2019
• Source: Ain Shams University
• Contact: Radwa M Elmetwaly, Bachelor
• Phone: 00201065371016
• Email: radwa_mohm[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia Renal

Intervention

Drug:
• Trental 400 MG Extended Release Oral Tablet
oral tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

References & Publications (7)

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. — View 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. — View Citation

Goicoechea M, García de Vinuesa S, Quiroga B, Verdalles U, Barraca D, Yuste C, Panizo N, Verde E, Muñoz MA, Luño 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. — View Citation

Johnson DW, Pollock CA, Macdougall IC. Erythropoiesis-stimulating agent hyporesponsiveness. Nephrology (Carlton). 2007 Aug;12(4):321-30. Review. — View 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. Review. — View 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. — View Citation

Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Inflammatory markers TNF-a, IL-1ß.	patient will be subjected to laboratory evaluation for estimation of IL-1ß,TNF-a levels at baseline as well as end of study evaluation	up to 6 months post baseline
Secondary	Difference in the dosage of erythropoiesis stimulating agents.	the dose of ESA will be assessed at end of study evaluation	up to 6 months post baseline
Secondary	The ESA ( erythropoiesis stimulating agents)resistance index (ERI).	ERI will be assessed for patients by determining ESA dose and hemoglobin concentration	up to 6 months post baseline