Anti-inflammatory Effect of Atorvastatin on Graft Donor Kidney
Anti-inflammatory Effect of Atorvastatin on Graft Donor Kidney Transplantation in Vivo
Renal Insufficiency is a priority disease in health system, which may require renal replacement therapy based on renal transplantation, which is considered as therapy of choice. During the procedure of renal transplantation, the graft could be damaged by ischemia-reperfusion which generates complications in its function.
Recently the anti-inflammatory and immunomodulatory effects of statins have been emphasized, which could be beneficial in renal transplantation.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Objective: Evaluate anti-inflammatory effect of atorvastatin on renal graft in living donor transplantation.
Material and methods: Controlled, double-blind clinical trial with posterior following for 12 months. Composed by 48 patients, randomized manner, realized at the Transplant Department of Western Medical Center, Mexican Institute of Social Security. Universe was patients accepted as kidney donors. Patients were randomized in two groups (study or control) the intervention was implemented 4 weeks before kidney transplant. Previous surgical procedure, in a blood sample, C-Reactive Protein (C-RP) and laboratory control were measured. During surgical procedure, a biopsy was obtained to measure IL-6 and tumoral necrosis factor alpha by immunohistochemistry. 24 hours after surgical procedure, 3 and 12 months of following, kidney function, complications and graft survival were registered. During surgical procedure, 3 months and 12 months of following, biopsies were obtain to performed histopathological analysis of scale of Banff
The statistical analysis was performed according to the nature of variables, for continuous data using measures of central tendency and dispersion and for the qualitative data with frequencies and percentages.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
Jalisco
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Guadalajara, Jalisco, Mexico, 44340
- Western Medical Center, Mexican Institute of Social Security
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Accepted as kidney donor
- Voluntary participation
- Informed consent accepted
- 85% fulfillment of atorvastatin treatment
Exclusion Criteria:
- Hypersensibility to Atorvastatin
- Smoking
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Atorvastatin
22 patients received oral atorvastatin 40 mg 1 time for day for 4 weeks
|
Patients were assigned to two groups, one of them received oral atorvastatin (study group) and the other, homologated placebo (control group) for 4 weeks before a kidney transplantation.
Previous surgical procedure controls were performed
Andre navn:
|
|
Placebo komparator: Placebo
22 patients received oral placebo 40 mg 1 time for day for 4 weeks
|
Patients were assigned to two groups, one of them received oral atorvastatin (study group) and the other, homologated placebo (control group) for 4 weeks before a kidney transplantation.
Previous surgical procedure were performed
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
C-Reactive Protein evolution in donors
Tidsramme: Basal and 4 weeks later
|
C-Reactive Protein was measured when patients (donors) were accepted in the study and 4 weeks later.
The last blood sample was taken the day of surgical procedure.
|
Basal and 4 weeks later
|
|
Kidney graft rejection using scale of BANFF
Tidsramme: Basal, 3 months and 12 months
|
During surgical procedure and before organ transplantation, basal biopsy was obtain.
In the following at 3 and 12 months after kidney transplantation, were performed the other two biopsy.
Alterations between groups were registered.
|
Basal, 3 months and 12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Kidney function evolution after transplant
Tidsramme: 24 hours, 3 months and 12 months
|
In blood samples, after kidney transplantation, creatinine and urea were measured.
Differences in evolution and alteration between the 2 groups were registered
|
24 hours, 3 months and 12 months
|
|
Interleukin and tumor necrosis factor alpha.
Tidsramme: Basal
|
During surgical procedure and before organ transplantation, the biopsy was obtain to measure interleukin 6 and tumor necrosis factor alpha, observing alteration between groups.
|
Basal
|
|
Complications
Tidsramme: 24 hours, 3 months and 12 months
|
During surgical procedure, any kind of complication was registered, the same right after surgery and in the following.
|
24 hours, 3 months and 12 months
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Clotilde Fuentes-Orozco, PhD, Instituto Mexicano del Seguro Social
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2011-1301-78
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