Monitoring of Biopsy-Proven Interstitial Polyomavirus Nep... | NCT00374283

Studies
Monitoring of Biopsy-Proven Interstitial Polyomavirus Nephritis in Kidney and Kidney Pancreas Transplant Recipients

NCT00374283

Sponsor

University of Cincinnati

Status

Completed

Last Update Posted

Jan 3, 2008Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Polyomavirus

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

Dec 2007

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

Jun 2001

Primary Completion Date

Not provided

Completion Date

Oct 2007Actual

First Submitted Date

Sep 8, 2006

First Submission Date that Met QC Criteria

Sep 8, 2006

First Posted Date

Sep 11, 2006Estimated

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 20, 2007

Last Update Posted Date

Jan 3, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Evaluate techniques for monitoring the course of interstitial therapy for polyomavirus nephritis in kidney and kidney pancreas transplant recipients by monitoring blood, urine, and renal transplant biopsies of patients affected by polyomavirus.

Detailed Description

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

40Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Recipients of a kidney or kidney pancreas transplant diagnosed with biopsy proven interstitial nephritis due to polyomavirus.
Age 18 to 70 years.
Capable of providing written informed consent.

Exclusion Criteria:

Age less than 18 years or greater than 70 years.
Patient is on chronic warfarin or heparin therapy or has a disease that puts them at risk of bleeding.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Prabir Roy-Chaudhury, MD, PhD	University of Cincinnati	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Christ Hospital		Cincinnati	Ohio	45267	United States
University of Cincinnati