Atorvastatin in the Recipient's Kidney Graft From a Living Donor
Information source: Instituto Mexicano del Seguro Social
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Insufficiency
Intervention: Atorvastatin (Drug); Placebo (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Instituto Mexicano del Seguro Social Official(s) and/or principal investigator(s): Clotilde Fuentes-Orozco, PhD, Principal Investigator, Affiliation: Instituto Mexicano del Seguro Social
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.
Clinical Details
Official title: Effectiveness of Atorvastatin on IL2, IL6, TNFalpha and HLA Levels in the Recipient's Kidney Graft From a Living Donor
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: HLA levels in the kidney graft biopsy
Secondary outcome: Renal functionKidney graft survival Surgery complications TNFalpha levels in the kidney graft biopsy IL2 and IL6 levels in the kidney graft biopsy
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Western Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco 44340, Mexico
Additional Information
Starting date: August 2015
Last updated: August 12, 2015
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