Does Oral Pentoxifylline Administration Improve Hemoglobin in Hemodialysis Patients?

NCT ID: NCT03731741

Last Updated: 2018-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2018-05-04

Brief Summary

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Our study investigated the effect of using a known drug used in intermittent claudication (named pentoxifylline) as an adjuvant to erythropoietin stimulating agents to improve anemia of hemodialysis patients.

Detailed Description

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Fifty out of 57 hemodialysis anemic patients were finally included. They were assigned to two groups of equal numbers. Oral Pentoxifylline 400mg once daily was added to the treatment group which was compared to the control group over a six months period regarding hemoglobin, hematocrit, serum albumin and CRP.

Inclusion criteria: (Patients with ESRD on HD who have hemoglobin \<11 g/dl, taking Erythropoietin alfa 4000 -12000 I.U/wk and having a urea reduction ratio \>65%.). There were 57 patients who met the inclusion criteria out of 158 patients.

Exclusion criteria: Iron deficiency anemia with transferrin saturation \<30%, intact PTH\>300pg/ml, vitamin B12 or folate deficiency (evidenced by macrocytosis), history of intolerance to pentoxifylline or other xanthine derivatives, recent retinal or cerebral hemorrhage or active peptic ulcer disease, pregnancy or breastfeeding, presence of systemic hematological disease or known hemoglobinopathy, major surgery, infection, acute myocardial infarction, or malignancy within the last three months and patients who refused to participate in the study.

Conditions

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Anemia of Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment group

Group I: 29 patients (25 completed the study) that received the study agent (400mg of oral pentoxifylline daily for 6 months.), besides the appropriate weight-based dose of ESA (60-150I.U/kg/wk).

Group Type EXPERIMENTAL

Pentoxifylline

Intervention Type DRUG

a known drug of xanthine derivatives used in intermittent claudication

control group

Group II: 28 patients (25 completed the study) who did not receive pentoxifylline but they received the appropriate dose of ESA. They were used as a control group and compared to group1 concerning the primary and the secondary outcomes.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pentoxifylline

a known drug of xanthine derivatives used in intermittent claudication

Intervention Type DRUG

Other Intervention Names

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Trental

Eligibility Criteria

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Exclusion Criteria

* Iron deficiency anemia with transferrin saturation \<30%, intact PTH\>300pg/ml, vitamin B12 or folate deficiency (evidenced by macrocytosis), history of intolerance to pentoxifylline or other xanthine derivatives, recent retinal or cerebral hemorrhage or active peptic ulcer disease, pregnancy or breastfeeding, presence of systemic hematological disease or known hemoglobinopathy, major surgery, infection, acute myocardial infarction, or malignancy within the last three months and patients who refused to participate in the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Sarah Abdel Mageed

Assistant lecturer of internal medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Atef Taha, M.D

Role: STUDY_DIRECTOR

Tanta university hospital

Locations

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Tanta university hospital

Tanta, , Egypt

Site Status

Countries

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Egypt

References

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Del Vecchio L, Locatelli F. Anemia in chronic kidney disease patients: treatment recommendations and emerging therapies. Expert Rev Hematol. 2014 Aug;7(4):495-506. doi: 10.1586/17474086.2014.941349.

Reference Type BACKGROUND
PMID: 25025373 (View on PubMed)

Kuragano T, Kitamura K, Matsumura O, Matsuda A, Hara T, Kiyomoto H, Murata T, Fujimoto S, Hase H, Joki N, Fukatsu A, Inoue T, Itakura Y, Nakanishi T. ESA Hyporesponsiveness Is Associated with Adverse Events in Maintenance Hemodialysis (MHD) Patients, But Not with Iron Storage. PLoS One. 2016 Mar 2;11(3):e0147328. doi: 10.1371/journal.pone.0147328. eCollection 2016.

Reference Type BACKGROUND
PMID: 26933949 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15213276 (View on PubMed)

Gonzalez-Espinoza L, Rojas-Campos E, Medina-Perez M, Pena-Quintero P, Gomez-Navarro B, Cueto-Manzano AM. Pentoxifylline decreases serum levels of tumor necrosis factor alpha, interleukin 6 and C-reactive protein in hemodialysis patients: results of a randomized double-blind, controlled clinical trial. Nephrol Dial Transplant. 2012 May;27(5):2023-8. doi: 10.1093/ndt/gfr579. Epub 2011 Oct 3.

Reference Type BACKGROUND
PMID: 21968012 (View on PubMed)

Other Identifiers

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pentoxifylline in inflammation

Identifier Type: -

Identifier Source: org_study_id

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