The Study of Long-term Deterioration of Kidney Transplants. | NCT00217126

Studies
The Study of Long-term Deterioration of Kidney Transplants.

NCT00217126

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Jan 3, 2013Estimated

Enrollment

870Actual

Phase

Not provided

Conditions

Kidney Transplant

Interventions

Not provided

Countries

United States

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

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Sep 16, 2005

First Submission Date that Met QC Criteria

Sep 16, 2005

First Posted Date

Sep 22, 2005Estimated

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

Jan 2, 2013

Last Update Posted Date

Jan 3, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Mayo ClinicOTHER

Collaborators

Name	Class
National Institutes of Health (NIH)	NIH
Hennepin County Medical Center, Minneapolis	OTHER
University of Alabama at Birmingham	OTHER
University of Alberta

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

Description Module

Brief Summary

This study is being done to create a kidney transplant database with information from many transplant centers for the purpose of studying ways to help improve transplant outcomes and the care of transplant recipients. This is also being done to learn why kidney transplant recipients have worsening of their kidney function, and whether there are specific findings that could result in future treatments.

Detailed Description

Data will be collected from the participant's medical records, local health care providers and participant's to clarify or add any information. Participants will have samples of blood, and urine obtained during their routine visits, that will be saved for testing in this study. In addition, participant's receiving a kidney biopsy performed as a part of their clinical care, will have a piece of the biopsy used for the study. This study will be followed for five years.

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

870Actual

Eligibility Module

Eligibility Criteria

In the prospective group, all participants who will be receiving a kidney transplant are eligible. In the retrospective group, kidney transplant recipients who are undergoing a kidney biopsy to determine the cause of change in their serum creatine level.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Kidney Transplant Recipients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fernando G. Cosio, M.D.	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Rochester	Minnesota	55905	United States