Overview

This trial is active, not recruiting.

Condition renal insufficiency
Treatments atorvastatin, placebo
Phase phase 3
Sponsor Instituto Mexicano del Seguro Social
Start date August 2015
End date April 2016
Trial size 48 participants
Trial identifier NCT02522117, R-2013-1301-100

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
24 patients received oral atorvastatin 40 mg once a day, for 4 weeks.
atorvastatin Lipitor
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 Comparator)
24 patients received oral placebo 40 mg once a day, for 4 weeks.
placebo Homologated 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.

Primary Outcomes

Measure
HLA levels in the kidney graft biopsy
time frame: 12 months

Secondary Outcomes

Measure
Renal function
time frame: 12 months
Kidney graft survival
time frame: 12 months
Surgery complications
time frame: 12 months
TNFalpha levels in the kidney graft biopsy
time frame: 12 months
IL2 and IL6 levels in the kidney graft biopsy
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Effectiveness of Atorvastatin on IL2, IL6, TNFalpha and HLA Levels in the Recipient's Kidney Graft From a Living Donor
Principal investigator Clotilde Fuentes-Orozco, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Instituto Mexicano del Seguro Social.