|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02522117 |
|
Date of registration:
|
07/08/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Atorvastatin in the Recipient's Kidney Graft From a Living Donor
ATORV15 |
|
Scientific title:
|
Effectiveness of Atorvastatin on IL2, IL6, TNFalpha and HLA Levels in the Recipient's Kidney Graft From a Living Donor |
|
Date of first enrolment:
|
August 2015 |
|
Target sample size:
|
48 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02522117 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Mexico
| | | | | | | |
|
Contacts
|
|
Name:
|
Clotilde Fuentes-Orozco, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Instituto Mexicano del Seguro Social |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Renal Insufficiency
|
|
Intervention(s)
|
|
Drug: Placebo
|
|
Drug: Atorvastatin
|
|
Primary Outcome(s)
|
|
HLA levels in the kidney graft biopsy
[Time Frame: 12 months]
|
|
Secondary Outcome(s)
|
|
Renal function
[Time Frame: 12 months]
|
|
IL2 and IL6 levels in the kidney graft biopsy
[Time Frame: 12 months]
|
|
Surgery complications
[Time Frame: 12 months]
|
|
Kidney graft survival
[Time Frame: 12 months]
|
|
TNFalpha levels in the kidney graft biopsy
[Time Frame: 12 months]
|
|
Secondary ID(s)
|
|
R-2013-1301-100
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|