- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01269827
Pentoxifylline and Systemic Inflammation in Hemodialysis Patients
Randomized, Double-Blinded, Controlled Clinical Trial of the Effect Pentoxifylline vs Placebo on the Serum Concentrations of TNF-a, IL-6 and CRP of Patients in Hemodialysis
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
Jalisco
-
Guadalajara, Jalisco, Mexico, 44320
- Hospital de Especialidades, CMNO, IMSS
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: placebo
|
Over a period of 4 months, patients of the control group received one starch tablet orally once a day (at dinner time)
Andre navne:
|
|
Eksperimentel: 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)
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
serum levels of TNF-a, IL-6 and CRP
Tidsramme: 4 months
|
4 months
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: Alfonso M. M Cueto-Manzano, MD, MSc, PhD, Unidad de Investigación Médica en Enfermedades Renales, Hospital de Especialidades, CMNO, IMSS
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Nyresygdomme
- Urologiske sygdomme
- Nyreinsufficiens
- Nyreinsufficiens, kronisk
- Betændelse
- Nyresvigt, kronisk
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Vasodilatorer
- Enzymhæmmere
- Blodpladeaggregationshæmmere
- Beskyttelsesagenter
- Antioxidanter
- Fosfodiesterasehæmmere
- Frie radikale scavengers
- Strålebeskyttende midler
- Pentoxifyllin
Andre undersøgelses-id-numre
- 2006-1A-I-007
- Other grant (Andet bevillings-/finansieringsnummer: NMRC/TCR/002 - SERI/2008 - TCR 621/41/2008])
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