Anti-inflammatory Effect of Atorvastatin on Graft Donor Kidney Transplantation in Vivo

NCT02355704 Phase 3 COMPLETED

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.

Details

Lead sponsor	Instituto Mexicano del Seguro Social
Phase	Phase 3
Status	COMPLETED
Enrolment	48
Start date	2012-01
Completion	2014-07

Conditions

• Renal Insufficiency

Interventions

• Atorvastatin
• Placebo

Primary outcomes

• C-Reactive Protein evolution in donors — 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.
• Kidney graft rejection using scale of BANFF — 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.

Countries

Mexico