Study of Prospective Assessment of Living Kidney Donors:... | NCT00813579

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

NCT00813579

Sponsor

Mansoura University

Status

Unknown status

Last Update Posted

Dec 23, 2008Estimated

Enrollment

80Estimated

Phase

Not provided

Conditions

Kidney Donation

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Jan 2010Estimated

Completion Date

Jan 2011Estimated

First Submitted Date

Dec 22, 2008

First Submission Date that Met QC Criteria

Dec 22, 2008

First Posted Date

Dec 23, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2008

Last Update Posted Date

Dec 23, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

65 Years

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24967244	Derived	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.