- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00374283
Monitoring of Biopsy-Proven Interstitial Polyomavirus Nephritis in Kidney and Kidney Pancreas Transplant Recipients
December 20, 2007 updated by: University of Cincinnati
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.
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45267
- University of Cincinnati
-
Cincinnati, Ohio, United States, 45267
- The Christ Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Prabir Roy-Chaudhury, MD, PhD, University of Cincinnati
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2001
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
September 8, 2006
First Submitted That Met QC Criteria
September 8, 2006
First Posted (Estimate)
September 11, 2006
Study Record Updates
Last Update Posted (Estimate)
January 3, 2008
Last Update Submitted That Met QC Criteria
December 20, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- POLYOMA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.