- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00813579
Study of Prospective Assessment of Living Kidney Donors: Pre and Post Donation
December 22, 2008 updated by: Mansoura University
Study of Prospective Assessment of Living Kidney Donors:Pre and Post Donation
This is a prospective assessment of 80 living kidney donors.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
80
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
A prspective one arm study of 80 live kidney donors .
Pre and post donation evaluation(clinical evaluation BLOOD PRESURE BMI, Laboratory evaluaion of renal hepatic functions ,lipid profil, blood sugar, complet blood count,urinanalysis for protein creatinine ratio ,psychological assesment and renal ultrasound for kidney size and any abnormality at 3,6,12,24 months post donation.
Description
Inclusion Criteria:
- Donors are suitable candidate for living donation
- Male or female donors minimum 21 years maximum 65 years of age
- Donors has been fully informed and has given written informed consent
Exclusion Criteria:
- Donors has diabetes mellitus or hypertension.
- Donors is pregnant or breastfeeding.
- Donors is known to be HCV,HBV,HIV positive or has significant liver disease.
- Donors with malignancy or history of malignancy.
- Donors has systemic or localized major infection.
- Donors is participating or has participated in another clinical trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Anticipated)
January 1, 2010
Study Completion (Anticipated)
January 1, 2011
Study Registration Dates
First Submitted
December 22, 2008
First Submitted That Met QC Criteria
December 22, 2008
First Posted (Estimate)
December 23, 2008
Study Record Updates
Last Update Posted (Estimate)
December 23, 2008
Last Update Submitted That Met QC Criteria
December 22, 2008
Last Verified
December 1, 2008
More Information
Terms related to this study
Other Study ID Numbers
- 1212 (Copenhagen University)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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