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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(8):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