Study of Prospective Assessment of Living Kidney Donors: Pre and Post Donation

This study is enrolling participants by invitation only.

Sponsored by:	Mansoura University
Information provided by:	Mansoura University
ClinicalTrials.gov Identifier:	NCT00813579

Purpose

This is a prospective assessment of 80 living kidney donors.

Condition
Kidney Donation

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Study of Prospective Assessment of Living Kidney Donors:Pre and Post Donation

Further study details as provided by Mansoura University:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Estimated Enrollment:	80
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	21 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Mansoura U ( Ayman Maher Nagib Kerilos )
Study ID Numbers:	1212
Study First Received:	December 22, 2008
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00813579
Health Authority:	Egypt: Institutional Review Board

Keywords provided by Mansoura University:

assess the safety of living kidney donation

ClinicalTrials.gov processed this record on January 13, 2009