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Anti-inflammatory Effect of Atorvastatin on Graft Donor Kidney

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ClinicalTrials.gov Identifier: NCT02355704
Recruitment Status : Completed
First Posted : February 4, 2015
Last Update Posted : February 4, 2015
Sponsor:
Information provided by (Responsible Party):
CLOTILDE FUENTES OROZCO, Instituto Mexicano del Seguro Social

Brief Summary:

Renal Insufficiency is a priority disease in health system, which may require renal replacement therapy based on renal transplantation, which is considered as therapy of choice. During the procedure of renal transplantation, the graft could be damaged by ischemia-reperfusion which generates complications in its function.

Recently the anti-inflammatory and immunomodulatory effects of statins have been emphasized, which could be beneficial in renal transplantation.


Condition or disease Intervention/treatment Phase
Renal Insufficiency Drug: Atorvastatin Drug: Placebo Phase 3

Detailed Description:

Objective: Evaluate anti-inflammatory effect of atorvastatin on renal graft in living donor transplantation.

Material and methods: Controlled, double-blind clinical trial with posterior following for 12 months. Composed by 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. Patients were randomized in two groups (study or control) the intervention was implemented 4 weeks before kidney transplant. Previous surgical procedure, in a blood sample, C-Reactive Protein (C-RP) and laboratory control were measured. During surgical procedure, a biopsy was obtained to measure IL-6 and tumoral necrosis factor alpha by immunohistochemistry. 24 hours after surgical procedure, 3 and 12 months of following, kidney function, complications and graft survival were registered. During surgical procedure, 3 months and 12 months of following, biopsies were obtain to performed histopathological analysis of scale of Banff

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Anti-inflammatory Effect of Atorvastatin on Graft Donor Kidney Transplantation in Vivo
Study Start Date : January 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Atorvastatin
22 patients received oral atorvastatin 40 mg 1 time for 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 a kidney transplantation. Previous surgical procedure controls were performed
Other Name: Lipitor

Placebo Comparator: Placebo
22 patients received oral placebo 40 mg 1 time for 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 a kidney transplantation. Previous surgical procedure were performed
Other Name: Homologated Placebo




Primary Outcome Measures :
  1. C-Reactive Protein evolution in donors [ Time Frame: Basal and 4 weeks later ]
    C-Reactive Protein was measured when patients (donors) were accepted in the study and 4 weeks later. The last blood sample was taken the day of surgical procedure.

  2. Kidney graft rejection using scale of BANFF [ Time Frame: Basal, 3 months and 12 months ]
    During surgical procedure and before organ transplantation, basal biopsy was obtain. In the following at 3 and 12 months after kidney transplantation, were performed the other two biopsy. Alterations between groups were registered.


Secondary Outcome Measures :
  1. Kidney function evolution after transplant [ Time Frame: 24 hours, 3 months and 12 months ]
    In blood samples, after kidney transplantation, creatinine and urea were measured. Differences in evolution and alteration between the 2 groups were registered

  2. Interleukin and tumor necrosis factor alpha. [ Time Frame: Basal ]
    During surgical procedure and before organ transplantation, the biopsy was obtain to measure interleukin 6 and tumor necrosis factor alpha, observing alteration between groups.

  3. Complications [ Time Frame: 24 hours, 3 months and 12 months ]
    During surgical procedure, any kind of complication was registered, the same right after surgery and in the following.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Accepted as kidney donor
  • Voluntary participation
  • Informed consent accepted
  • 85% fulfillment of atorvastatin treatment

Exclusion Criteria:

  • Hypersensibility to Atorvastatin
  • Smoking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355704


Locations
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Mexico
Western Medical Center, Mexican Institute of Social Security
Guadalajara, Jalisco, Mexico, 44340
Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Investigators
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Study Director: Clotilde Fuentes-Orozco, PhD Instituto Mexicano del Seguro Social

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Responsible Party: CLOTILDE FUENTES OROZCO, PhD, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT02355704     History of Changes
Other Study ID Numbers: 2011-1301-78
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: January 2015
Keywords provided by CLOTILDE FUENTES OROZCO, Instituto Mexicano del Seguro Social:
Kidney Transplantation
Atorvastatin
C-Reactive Protein
Biopsy
Interleukin
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Atorvastatin
Anti-Inflammatory Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors