Atorvastatin in the Recipient's Kidney Graft From a Living Donor

Renal Insufficiency Clinical Trial

— ATORV15  

Official title:

Effectiveness of Atorvastatin on IL2, IL6, TNFalpha and HLA Levels in the Recipient's Kidney Graft From a Living Donor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02522117
• Other study ID #: R-2013-1301-100
• Status: Completed
• Phase: Phase 3
• Start date: August 2015
• Est. completion date: January 2018

Study information

• Verified date: September 2018
• Source: Instituto Mexicano del Seguro Social
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Renal insufficiency is a priority disease in the health system, which may require renal replacement therapy based on kidney transplantation, which is considered as therapy of choice. During the procedure of kidney transplantation, the body is subjected to ischemia-reperfusion damage that generates late complications related to graft function.

Recently the anti-inflammatory and immunomodulatory effects of statins have been emphasized, which could be beneficial in kidney transplantation.

Description:

Objective: Evaluate the effect of atorvastatin on IL2, IL6, TNFalpha and HLA levels in the recipient's kidney graft from a living donor.

Material and methods: Controlled, double-blind trial with 12 months follow-up. Composed of 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 and their recipients. Patients included as donors were randomized into two groups (study or control) the intervention was implemented 4 weeks before kidney transplant. During surgical procedure, a biopsy from the recipient's kidney graft was obtained to measure IL-2, IL-6 TNFalpha and HLA by immunohistochemistry, 3 and 12 months after surgery. Recipients kidney function, surgical complications and kidney graft survival were registered. During surgical procedure, 3 and 12 months of following, biopsies were obtain to performed histopathological analysis based on Banff classification of renal allograft rejection grades.

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. Inferential analysis with student's t-test, and/or Mann-Whitney's U test; chi-square distribution, and/or Fisher's exact test respectively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Donors Inclusion Criteria:

• Accepted as kidney donor

• Voluntary participation

• Informed consent accepted

• 85% fulfillment of atorvastatin treatment

• Entitlement to the Mexican Institute of Social Security

Donors Exclusion Criteria:

• Hypersensibility to Atorvastatin

• Smoking

Recipients Inclusion Criteria:

• Accepted as kidney recipient

• Entitlement to the Mexican Institute of Social Security

Recipients Exclusion Criteria:

• Patients who dropped out from study or withdrew the informed consent

• Insufficient kidney biopsy

Related Conditions & MeSH terms

• Renal Insufficiency

Intervention

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 transplant. Then IL2, IL6, TNFalpha and HLA levels were assessed in the recipient's kidney graft by visual analog scale at prior reperfusion, and after 3 and 12 months.
• 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 transplant. Then IL2, IL6, TNFalpha and HLA levels were assessed in the recipient's kidney graft by visual analog scale at prior reperfusion, and after 3 and 12 months.

Locations

Country	Name	City	State
Mexico	Western Medical Center, Mexican Institute of Social Security	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HLA levels in the kidney graft biopsy	HLA levels were measure by immunohistochemistry, observing alteration between groups.	12 months
Secondary	Renal function	In a blood sample and in a urine 24-hour collection, serum creatinine, serum urea, creatinine clearance, urine output, and proteinuria were measure. Differences in evolution and alteration between the 2 groups were registered.	12 months
Secondary	Kidney graft survival	In a renal biopsy using the Banff classification of renal allograft rejection grades, were assessed histologic and molecular features by microscopy and immunofluorescence. Alterations between groups were registered.	12 months
Secondary	Surgery complications	During surgical procedure and following, any kind of complication was registered.	12 months
Secondary	TNFalpha levels in the kidney graft biopsy	TNFalpha levels were measure by immunohistochemistry, observing alteration between groups.	12 months
Secondary	IL2 and IL6 levels in the kidney graft biopsy	IL2 and IL6 levels were measure by immunohistochemistry, observing alteration between groups.	12 months