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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 function

Kidney 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

Page last updated: August 23, 2015

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