Pentoxifylline and Systemic Inflammation in Hemodialysis Patients

NCT01269827 | Completed Phase 4 DMC

• 2 other identifiers: 2006-1A-I-007other grant
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammation; End-stage Renal Disease; Hemodialysis

Keywords

inflammation; pentoxifylline; hemodialysis

Outcome Measures

Primary Outcomes (1)

• serum levels of TNF-a, IL-6 and CRP

  4 months

Study Arms (2)

pentoxifylline

EXPERIMENTAL

Drug: Pentoxifylline

placebo

PLACEBO COMPARATOR

Drug: starch tablets

Interventions

Pentoxifylline 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)

Also known as: trental

pentoxifylline

starch tablets DRUG

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

Also known as: placebo

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (1)

Hospital de Especialidades, CMNO, IMSS

Guadalajara, Jalisco, 44320, Mexico

Location

MeSH Terms

Conditions

Inflammation; Kidney Failure, Chronic

Interventions

Pentoxifylline; Starch

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

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

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jefe de Unidad de Investigación Médica en Enfermedades Renales, HE, CMNO, IMSS

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: January 4, 2011
• Study Start: January 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

ME (1)