Anti-inflammatory Effect of Atorvastatin on Graft Donor Kidney
Primary Purpose
Renal Insufficiency
Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Atorvastatin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Renal Insufficiency focused on measuring Kidney Transplantation, Atorvastatin, C-Reactive Protein, Biopsy, Interleukin
Eligibility Criteria
Inclusion Criteria:
- Accepted as kidney donor
- Voluntary participation
- Informed consent accepted
- 85% fulfillment of atorvastatin treatment
Exclusion Criteria:
- Hypersensibility to Atorvastatin
- Smoking
Sites / Locations
- Western Medical Center, Mexican Institute of Social Security
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Atorvastatin
Placebo
Arm Description
22 patients received oral atorvastatin 40 mg 1 time for day for 4 weeks
22 patients received oral placebo 40 mg 1 time for day for 4 weeks
Outcomes
Primary Outcome Measures
C-Reactive Protein evolution in donors
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.
Kidney graft rejection using scale of BANFF
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
Kidney function evolution after transplant
In blood samples, after kidney transplantation, creatinine and urea were measured. Differences in evolution and alteration between the 2 groups were registered
Interleukin and tumor necrosis factor alpha.
During surgical procedure and before organ transplantation, the biopsy was obtain to measure interleukin 6 and tumor necrosis factor alpha, observing alteration between groups.
Complications
During surgical procedure, any kind of complication was registered, the same right after surgery and in the following.
Full Information
NCT ID
NCT02355704
First Posted
January 22, 2015
Last Updated
January 30, 2015
Sponsor
Instituto Mexicano del Seguro Social
1. Study Identification
Unique Protocol Identification Number
NCT02355704
Brief Title
Anti-inflammatory Effect of Atorvastatin on Graft Donor Kidney
Official Title
Anti-inflammatory Effect of Atorvastatin on Graft Donor Kidney Transplantation in Vivo
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Mexicano del Seguro Social
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency
Keywords
Kidney Transplantation, Atorvastatin, C-Reactive Protein, Biopsy, Interleukin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atorvastatin
Arm Type
Active Comparator
Arm Description
22 patients received oral atorvastatin 40 mg 1 time for day for 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
22 patients received oral placebo 40 mg 1 time for day for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Homologated Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
C-Reactive Protein evolution in donors
Description
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.
Time Frame
Basal and 4 weeks later
Title
Kidney graft rejection using scale of BANFF
Description
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.
Time Frame
Basal, 3 months and 12 months
Secondary Outcome Measure Information:
Title
Kidney function evolution after transplant
Description
In blood samples, after kidney transplantation, creatinine and urea were measured. Differences in evolution and alteration between the 2 groups were registered
Time Frame
24 hours, 3 months and 12 months
Title
Interleukin and tumor necrosis factor alpha.
Description
During surgical procedure and before organ transplantation, the biopsy was obtain to measure interleukin 6 and tumor necrosis factor alpha, observing alteration between groups.
Time Frame
Basal
Title
Complications
Description
During surgical procedure, any kind of complication was registered, the same right after surgery and in the following.
Time Frame
24 hours, 3 months and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Accepted as kidney donor
Voluntary participation
Informed consent accepted
85% fulfillment of atorvastatin treatment
Exclusion Criteria:
Hypersensibility to Atorvastatin
Smoking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clotilde Fuentes-Orozco, PhD
Organizational Affiliation
Instituto Mexicano del Seguro Social
Official's Role
Study Director
Facility Information:
Facility Name
Western Medical Center, Mexican Institute of Social Security
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
Anti-inflammatory Effect of Atorvastatin on Graft Donor Kidney
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