Clinical Trials: Graft Survival in Kidney Transplant Patients

Noninvasive Methods to Monitor Graft Survival in Kidney Transplant Patients

This study is currently recruiting participants.
Verified by National Institute of Allergy and Infectious Diseases (NIAID), April 2007

Sponsored by:    National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:    National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:    NCT00308802
Purpose

The purpose of this study is to test noninvasive methods to monitor the health and condition of new kidneys in people who have received kidney transplants.

Condition    Intervention
Kidney Transplantation
   Procedure: Kidney transplantation

MedlinePlus related topics:     Kidney Transplantation

U.S. FDA Resources

Study Type:     Observational
Study Design:     Case-Only, Prospective
Official Title:     Noninvasive Monitoring to Predict Outcome in De Novo Kidney Transplant Recipients

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Blood samples may be retained

Estimated Enrollment:     360
Study Start Date:     March 2006
Estimated Study Completion Date:     March 2010

Intervention Details:

Procedure: Kidney transplantation
Participants in this study will have had a kidney transplant

Detailed Description:

Innovations in kidney transplantation have improved short-term outcomes for transplant patients. However, organ rejection remains as an important threat to the long-term survival of the transplanted organ. If clinicians could better monitor the condition of the organ after transplantation, they may be able to improve the chance of graft survival. Noninvasive ways to monitor the condition of the transplanted organ need to be developed and tested. This observational study will investigate whether certain blood and urine tests are useful in monitoring the health of transplanted kidneys.

This trial will involve 14 post-transplant study visits over the course of 2 years. A physical exam, medication history, adverse events assessment, and blood and urine collection will occur at all visits. Kidney biopsies will occur at study entry prior to transplantation and at Month 6, in adult participants only. Protocol biopsies are optional in the pediatric substudy group. Additional visits may be required if organ rejection is suspected.
Eligibility
Genders Eligible for Study:     Both
Accepts Healthy Volunteers:     No
Sampling Method:     Non-Probability Sample

Study Population

People who are candidates for kidney transplant

Criteria

Inclusion Criteria:

* Candidate for deceased donor or living donor kidney transplant
* Primary kidney transplant recipient
* Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

* Clinically significant liver disease
* Other illnesses that, in the opinion of the investigator, may interfere with the study
* Recipient of multiple organ transplants
* Inability or unwillingness to comply with the study protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308802

Contacts
Contact: Yvonne Morrison, MS     301-451-3139     ymorrison@niaid.nih.gov

Locations
United States, Connecticut
   Yale University School of Medicine        Recruiting
     New Haven, Connecticut, United States, 06510
     Contact: Danielle Lettieri 203-785-7031 danielle.lettieri@yale.edu
     Principal Investigator: Richard Formica, MD
United States, Georgia
   Emory University Hospital        Recruiting
     Atlanta, Georgia, United States, 30322
     Contact: Amy Lewis 404-712-1644 amy_lewis@emoryhealthcare.org
     Principal Investigator: Kenneth Newell, MD
   Emory Children's Center        Recruiting
     Atlanta, Georgia, United States, 30322
     Contact: Margret Kamel 404-712-9923 Margret_kamel@oz.peds.emory.edu
     Principal Investigator: Barry Warsaw, MD
United States, New York
   Mount Sinai School of Medicine        Recruiting
     New York, New York, United States, 10029
     Contact: Hurdley Freemantle 212-659-8041 hurdley.freemantle@mountsinai.org
     Principal Investigator: Enver Akalin, MD
United States, Ohio
   Cleveland Clinic Foundation        Recruiting
     Cleveland, Ohio, United States, 44195
     Contact: Leslie Iosue 216-444-2991 iosuel@ccf.org
     Principal Investigator: Emilio Poggio, MD
   University Hospitals of Cleveland        Recruiting
     Cleveland, Ohio, United States, 44195
     Contact: Maureen Tessman 216-844-5395 maureen.tessman@uhhs.com
     Principal Investigator: Donald Hricik, MD
   Cincinnati Children's Hospital Medical Center        Recruiting
     Cincinnati, Ohio, United States, 45229
     Contact: Barbara Logan 513-636-9834 barbara.logan@cchmc.org
     Principal Investigator: Jens Goebel, MD
Canada, Manitoba
   University of Manitoba        Recruiting
     Winnipeg, Manitoba, Canada, R3T 2N2
     Contact: Myrna Ross 204-787-3618 mdross@hsc.mb.ca
     Principal Investigator: David Rush, MD

Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

Investigators
Study Director:     Peter S. Heeger, MD     Mount Sinai School of Medicine
Principal Investigator:     Donald Hricik, MD     University Hospitals of Cleveland
Principal Investigator:     David Rush, MD     University of Manitoba at Winnipeg
Principal Investigator:     Kenneth Newell, MD     Emory University
Principal Investigator:     Richard Formica, MD     Yale University
Principal Investigator:     Emilio Poggio, MD     The Cleveland Clinic
Principal Investigator:     Barry Warshaw, MD     Emory Children's Center
Principal Investigator:     Enver Akalin, MD     Mount Sinai School of Medicine
More Information

Click here for the Clinical Trials in Organ Transplantation (CTOT) public Web site This link exits the ClinicalTrials.gov site

Publications:
Kaplan B, Srinivas TR, Meier-Kriesche HU. Factors associated with long-term renal allograft survival. Ther Drug Monit. 2002 Feb;24(1):36-9. Review.

Meier-Kriesche HU, Schold JD, Kaplan B. Long-term renal allograft survival: have we made significant progress or is it time to rethink our analytic and therapeutic strategies? Am J Transplant. 2004 Aug;4(

:1289-95.

Meier-Kriesche HU, Schold JD, Srinivas TR, Kaplan B. Lack of improvement in renal allograft survival despite a marked decrease in acute rejection rates over the most recent era. Am J Transplant. 2004 Mar;4(3):378-83.

Study ID Numbers:     DAIT CTOT-01
First Received:     March 28, 2006
Last Updated:     February 11, 2008
ClinicalTrials.gov Identifier:     NCT00308802
Health Authority:     United States: Federal Government; United States: Institutional Review Board

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Kidney
Transplant
Rejection

Kidney Disease
Kidney Failure
End Stage Renal Disease

Study placed in the following topic categories:
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on September 23, 2008
http://clinicaltrials.gov/ct2/show/NCT00308802