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Does Oral Pentoxifylline Administration Improve Hemoglobin in Hemodialysis Patients?

Primary Purpose

Anemia of Chronic Kidney Disease

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Pentoxifylline
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia of Chronic Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tanta university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

treatment group

control group

Arm Description

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 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.

Outcomes

Primary Outcome Measures

hemoglobin difference
the difference in haemoglobin concentration between the pentoxifylline and control group at the end of the 6 months study period.

Secondary Outcome Measures

difference in inflammatory markers
Difference in CRP and albumin levels between the two groups

Full Information

First Posted
November 2, 2018
Last Updated
November 6, 2018
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT03731741
Brief Title
Does Oral Pentoxifylline Administration Improve Hemoglobin in Hemodialysis Patients?
Official Title
Effect of Pentoxifylline Administration on Hemoglobin Level of Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
May 3, 2018 (Actual)
Study Completion Date
May 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia of Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment group
Arm Type
Experimental
Arm Description
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).
Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pentoxifylline
Other Intervention Name(s)
Trental
Intervention Description
a known drug of xanthine derivatives used in intermittent claudication
Primary Outcome Measure Information:
Title
hemoglobin difference
Description
the difference in haemoglobin concentration between the pentoxifylline and control group at the end of the 6 months study period.
Time Frame
after 6 months from the start
Secondary Outcome Measure Information:
Title
difference in inflammatory markers
Description
Difference in CRP and albumin levels between the two groups
Time Frame
after 6 months from the start

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atef Taha, M.D
Organizational Affiliation
Tanta university hospital
Official's Role
Study Director
Facility Information:
Facility Name
Tanta university hospital
City
Tanta
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
25025373
Citation
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.
Results Reference
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PubMed Identifier
26933949
Citation
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.
Results Reference
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PubMed Identifier
15213276
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.
Results Reference
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PubMed Identifier
21968012
Citation
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.
Results Reference
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Does Oral Pentoxifylline Administration Improve Hemoglobin in Hemodialysis Patients?

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