NCT00813579

Brief Summary

This is a prospective assessment of 80 living kidney donors.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2008

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

December 23, 2008

Status Verified

December 1, 2008

Enrollment Period

2 years

First QC Date

December 22, 2008

Last Update Submit

December 22, 2008

Conditions

Keywords

assess the safety of living kidney donation

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Nagib AM, Refaie AF, Hendy YA, Elfawal MA, Shokeir AA, Bakr MA, Neamattala AH, Hamdy AF, Mahmoud KM, Ismail AM, Ghoneim MA. Long term prospective assessment of living kidney donors: single center experience. ISRN Nephrol. 2014 Jan 23;2014:502414. doi: 10.1155/2014/502414. eCollection 2014.

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 22, 2008

First Posted

December 23, 2008

Study Start

January 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2011

Last Updated

December 23, 2008

Record last verified: 2008-12