Skip to main content
OpenTrials
Completed

NCT Number: NCT02522117

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Western Medical Center, Mexican Institute of Social Security

Guadalajara, Jalisco, 44340, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin

Drug

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.

Other names: Lipitor

Placebo

Drug

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.

Other names: Homologated placebo

Primary outcomes

  1. HLA levels in the kidney graft biopsy

    Time frame: 12 months

    HLA levels were measure by immunohistochemistry, observing alteration between groups.

Secondary outcomes

  1. Renal function

    Time frame: 12 months

    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.

  2. Kidney graft survival

    Time frame: 12 months

    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.

  3. Surgery complications

    Time frame: 12 months

    During surgical procedure and following, any kind of complication was registered.

  4. TNFalpha levels in the kidney graft biopsy

    Time frame: 12 months

    TNFalpha levels were measure by immunohistochemistry, observing alteration between groups.

  5. IL2 and IL6 levels in the kidney graft biopsy

    Time frame: 12 months

    IL2 and IL6 levels were measure by immunohistochemistry, observing alteration between groups.

Sponsors and collaborators

Lead sponsor

Instituto Mexicano del Seguro Social

Other Gov

Registry information

Official study title

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

Acronym: ATORV15

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
Aug 13, 2015
Registry last updated
Sep 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.