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Pentoxifylline and Systemic Inflammation in Hemodialysis Patients

NCT ID: NCT01269827

Last Updated: 2018-12-19

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

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-05-31

Brief Summary

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The aim of this study was to compare the effect of PTX vs placebo on serum concentrations of TNF-α, IL-6, and CRP in patients on hemodialysis.

Detailed Description

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Patients were randomly selected from the total HD patients of our hospital. Once included, patients were randomly allocated (by a computer-generated randomization list) to a study or control group. Over a period of 4 months, patients of the study group received one PTX tablet (400 mg) orally once a day (at dinner time), whereas controls received one starch identical tablet on the same schedule.

All patients had three HD sessions per week, with the same kind of single-use dialysis membrane and dialysate. Monthly visits were scheduled for clinical and biochemical evaluations. A blood sample was taken at baseline and every month for measurement of complete blood count, urea, creatinine, glucose, albumin, lipids, and electrolytes (measured by usual methods). In serum samples at 0, 2 and 4 months, TNF-α and IL-6 concentrations were measured by ELISA using high sensitivity kits (Amersham Pharmacia Biotech, Buckinghamshire, UK). Additionally, in the same serum samples, CRP concentrations were measured by nephelometry using high sensitivity kits (Dade Behring, Marburg, Germany) in a Nephelometry Analyzer II (Dade Behring, Marburg, Germany). All laboratory measurements, including inflammation markers, were performed in the Central Laboratory (Hospital de Especialidades, CMNO), by the same personnel blinded to patient's details.

Treatment compliance was recorded by counting tablets left in the container at the end of each monthly visit.

Conditions

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Inflammation End-stage Renal Disease Hemodialysis

Keywords

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inflammation pentoxifylline hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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pentoxifylline

Group Type EXPERIMENTAL

Pentoxifylline

Intervention Type DRUG

Over a period of 4 months, patients of the study group received one PTX tablet (400 mg) orally once a day (at dinner time)

placebo

Group Type PLACEBO_COMPARATOR

starch tablets

Intervention Type DRUG

Over a period of 4 months, patients of the control group received one starch tablet orally once a day (at dinner time)

Interventions

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Pentoxifylline

Over a period of 4 months, patients of the study group received one PTX tablet (400 mg) orally once a day (at dinner time)

Intervention Type DRUG

starch tablets

Over a period of 4 months, patients of the control group received one starch tablet orally once a day (at dinner time)

Intervention Type DRUG

Other Intervention Names

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trental placebo

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years,
* ≥2 months on HD,
* arteriovenous fistula as vascular access, and
* endorsement of informed consent.

Exclusion Criteria

* inflammatory cause of ESRD,
* liver disease, cancer, AIDS,
* any infectious disease 2 months before the study,
* failed kidney graft,
* hypersensitivity to PTX or other methylxanthines,
* hemorrhage/clotting disorders,
* risk for worsening pre-existing cardiac arrhythmias or arterial hypotension,
* treatment with antibiotics, non-steroidal anti-inflammatory drugs, steroids, immunosuppressives, statins or PTX 3 months previous to the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Coordinación de Investigación en Salud, Mexico

OTHER_GOV

Sponsor Role lead

Responsible Party

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Alfonso Martín Cueto Manzano

Jefe de Unidad de Investigación Médica en Enfermedades Renales, HE, CMNO, IMSS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alfonso M. M Cueto-Manzano, MD, MSc, PhD

Role: STUDY_CHAIR

Unidad de Investigación Médica en Enfermedades Renales, Hospital de Especialidades, CMNO, IMSS

Locations

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Hospital de Especialidades, CMNO, IMSS

Guadalajara, Jalisco, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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other grant

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2006-1A-I-007

Identifier Type: -

Identifier Source: org_study_id