Kidney DonationNCT00813579
Study of Prospective Assessment of Living Kidney Donors: Pre and Post Donation
An observational study of Kidney Donation, run by Mansoura University.
Trial summary
This is a prospective assessment of 80 living kidney donors. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Kidney Donation
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Study of Prospective Assessment of Living Kidney Donors:Pre and Post Donation
This is a prospective assessment of 80 living kidney donors.
- Conditions
- Kidney Donation
- Keywords
- assess the safety of living kidney donation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2010 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney DonationStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813579
- Sponsor's protocol ID
- 1212
- Status last verified
- Dec 2008
- First submitted
- 22 Dec 2008
- Last updated
- 23 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24967244
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Prospective Assessment of Living Kidney Donors:Pre and Post Donation
- ClinicalTrials.gov ID
- NCT00813579
- Acronym / sponsor ID
- 1212
- Conditions
- Kidney Donation
- Keywords
- assess the safety of living kidney donation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 23 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective assessment of 80 living kidney donors.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2008.
- Derived from this study: PubMed 24967244Nagib 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Donation, run by Mansoura University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00813579, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2008.