Anti-inflammatory Effect of Atorvastatin on Graft Donor Kidney
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 22, 2015
CompletedFirst Posted
Study publicly available on registry
February 4, 2015
CompletedFebruary 4, 2015
January 1, 2015
2.2 years
January 22, 2015
January 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Basal and 4 weeks later
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.
Basal, 3 months and 12 months
Secondary Outcomes (3)
Kidney function evolution after transplant
24 hours, 3 months and 12 months
Interleukin and tumor necrosis factor alpha.
Basal
Complications
24 hours, 3 months and 12 months
Study Arms (2)
Atorvastatin
ACTIVE COMPARATOR22 patients received oral atorvastatin 40 mg 1 time for day for 4 weeks
Placebo
PLACEBO COMPARATOR22 patients received oral placebo 40 mg 1 time for day for 4 weeks
Interventions
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
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
Eligibility Criteria
You may qualify if:
- Accepted as kidney donor
- Voluntary participation
- Informed consent accepted
- % fulfillment of atorvastatin treatment
You may not qualify if:
- Hypersensibility to Atorvastatin
- Smoking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Western Medical Center, Mexican Institute of Social Security
Guadalajara, Jalisco, 44340, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clotilde Fuentes-Orozco, PhD
Instituto Mexicano del Seguro Social
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
January 22, 2015
First Posted
February 4, 2015
Study Start
January 1, 2012
Primary Completion
April 1, 2014
Study Completion
July 1, 2014
Last Updated
February 4, 2015
Record last verified: 2015-01