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.

Study Overview

• Status: Completed
• Conditions: Renal Insufficiency
• Intervention / Treatment: Drug: Atorvastatin; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44340
      • Western Medical Center, Mexican Institute of Social Security

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Accepted as kidney donor
• Voluntary participation
• Informed consent accepted
• 85% fulfillment of atorvastatin treatment

Exclusion Criteria:

• Hypersensibility to Atorvastatin
• Smoking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Atorvastatin; 22 patients received oral atorvastatin 40 mg 1 time for day for 4 weeks	Drug: Atorvastatin; 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; Other Names: Lipitor
Placebo Comparator: Placebo; 22 patients received oral placebo 40 mg 1 time for day for 4 weeks	Drug: Placebo; 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; Other Names: Homologated Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C-Reactive Protein evolution in donors	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kidney function evolution after transplant	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.	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	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

Collaborators and Investigators

• Sponsor: Instituto Mexicano del Seguro Social
• Investigators: Study Director: Clotilde Fuentes-Orozco, PhD, Instituto Mexicano del Seguro Social

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: January 22, 2015
• First Submitted That Met QC Criteria: January 30, 2015
• First Posted (Estimate): February 4, 2015

Study Record Updates

• Last Update Posted (Estimate): February 4, 2015
• Last Update Submitted That Met QC Criteria: January 30, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: C-Reactive Protein; Biopsy; Kidney Transplantation; Atorvastatin; Interleukin
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: 2011-1301-78