NCT03731741

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
Last Updated

November 8, 2018

Status Verified

November 1, 2018

Enrollment Period

6 months

First QC Date

November 2, 2018

Last Update Submit

November 6, 2018

Conditions

Anemia of Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • hemoglobin difference

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

    after 6 months from the start

Secondary Outcomes (1)

  • difference in inflammatory markers

    after 6 months from the start

Study Arms (2)

treatment group

EXPERIMENTAL

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).

Drug: Pentoxifylline

control group

NO INTERVENTION

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.

Interventions

PentoxifyllineDRUG

a known drug of xanthine derivatives used in intermittent claudication

Also known as: Trental
treatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta university hospital

Tanta, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 25025373BACKGROUND

  • 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.

    PMID: 26933949BACKGROUND

  • 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: 15213276BACKGROUND

  • 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.

    PMID: 21968012BACKGROUND

MeSH Terms

Interventions

Pentoxifylline

Intervention Hierarchy (Ancestors)

TheobromineXanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Atef Taha, M.D

    Tanta university hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of internal medicine

Study Record Dates

First Submitted

November 2, 2018

First Posted

November 6, 2018

Study Start

November 1, 2017

Primary Completion

May 3, 2018

Study Completion

May 4, 2018

Last Updated

November 8, 2018

Record last verified: 2018-11

Locations

EG(1)