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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03155763 |
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Date of registration:
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13/05/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Histology of Implantation Biopsies and Kidney Allograft Outcomes
KALIMBO |
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Scientific title:
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Impact of Acute and Chronic Individual Histological Lesions and Composite Scores in Implantation Biopsies on Short-term and Long-term Kidney Allograft Outcomes |
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Date of first enrolment:
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April 1, 2005 |
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Target sample size:
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130 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03155763 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Ukraine
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Contacts
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Name:
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Andriy V Trailin, MD, DSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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State Institution, Zaporizhzhia Medical Academy of Post-Graduate Education Ministry of Health of Ukraine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- adult kidney transplant recipients who underwent transplantation at Zaporizhzhia
Transplant Center;
- cadaveric or living single kidney only transplant;
- informed written consent;
- adequate intraoperative biopsy (in total = 7 glomeruli and = 1 arteries in preimplant
and postreperfusion biopsies);
- complete follow-up data up to 5 years.
Exclusion Criteria:
- not consent with research;
- non-complete follow-up data up to 5 years.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Kidney Graft Dysfunction
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Intervention(s)
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Procedure: Intraoperative kidney allograft preimplantation biopsy; Intraoperative kidney allograft postreperfusion biopsy
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Primary Outcome(s)
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Five-year death-censored kidney allograft survival
[Time Frame: Five years]
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Secondary Outcome(s)
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Slow graft function
[Time Frame: The day 8]
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Pyelonephritis
[Time Frame: During five years]
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Acute rejection
[Time Frame: During five years]
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Delayed graft function
[Time Frame: The day 8]
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Allograft function at 1, 3, 6, 12 months, 2, 3, 4 and 5 years
[Time Frame: During five years]
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One-year death-censored kidney allograft survival
[Time Frame: One year]
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Secondary ID(s)
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0105U007599
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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