ATORV15: Atorvastatin in the Recipient's Kidney Graft From a Living Donor
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Atorvastatin 24 patients received oral atorvastatin 40 mg once a 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 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:
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| Placebo Comparator: Placebo 24 patients received oral placebo 40 mg once a 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 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:
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Outcome Measures
Primary Outcome Measures
- HLA levels in the kidney graft biopsy [12 months]
HLA levels were measure by immunohistochemistry, observing alteration between groups.
Secondary Outcome Measures
- Renal function [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.
- Kidney graft survival [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.
- Surgery complications [12 months]
During surgical procedure and following, any kind of complication was registered.
- TNFalpha levels in the kidney graft biopsy [12 months]
TNFalpha levels were measure by immunohistochemistry, observing alteration between groups.
- IL2 and IL6 levels in the kidney graft biopsy [12 months]
IL2 and IL6 levels were measure by immunohistochemistry, observing alteration between groups.
Eligibility Criteria
Criteria
Donors Inclusion Criteria:
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Accepted as kidney donor
-
Voluntary participation
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Informed consent accepted
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85% fulfillment of atorvastatin treatment
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Entitlement to the Mexican Institute of Social Security
Donors Exclusion Criteria:
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Hypersensibility to Atorvastatin
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Smoking
Recipients Inclusion Criteria:
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Western Medical Center, Mexican Institute of Social Security | Guadalajara | Jalisco | Mexico | 44340 |
Sponsors and Collaborators
- Instituto Mexicano del Seguro Social
Investigators
- Principal Investigator: Clotilde Fuentes-Orozco, PhD, Instituto Mexicano del Seguro Social
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R-2013-1301-100