Noninvasive Methods to Monitor Graft Survival in Kidney Transplant Patients
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00308802 |
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Recruitment Status :
Completed
First Posted : March 30, 2006
Last Update Posted : September 2, 2013
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| Condition or disease | Intervention/treatment |
|---|---|
| Kidney Transplantation | Procedure: Kidney transplantation |
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.
| Study Type : | Observational |
| Actual Enrollment : | 280 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Noninvasive Monitoring to Predict Outcome in De Novo Kidney Transplant Recipients |
| Study Start Date : | March 2006 |
| Actual Primary Completion Date : | July 2011 |
| Actual Study Completion Date : | July 2011 |
- Procedure: Kidney transplantation
Participants in this study will have had a kidney transplant
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Candidate for deceased donor or living donor kidney transplant
- Negative Crossmatch
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00308802
| United States, Connecticut | |
| Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06510 | |
| United States, Georgia | |
| Emory Children's Center | |
| Atlanta, Georgia, United States, 30322 | |
| Emory University Hospital | |
| Atlanta, Georgia, United States, 30322 | |
| United States, New York | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229 | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| University Hospitals of Cleveland | |
| Cleveland, Ohio, United States, 44195 | |
| Canada, Manitoba | |
| Children's Hospital of Winnipeg | |
| Winnipeg, Manitoba, Canada, R3A 151 | |
| University of Manitoba | |
| Winnipeg, Manitoba, Canada, R3A 1R9 | |
| Study Director: | Peter S. Heeger, MD | Icahn School of Medicine at Mount Sinai | |
| Principal Investigator: | Donald Hricik, MD | University Hospitals Cleveland Medical Center | |
| 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 | Icahn School of Medicine at Mount Sinai | |
| Principal Investigator: | Patricia Birk, M.D. | Children's Hospital of Winnipeg |
Publications of Results:
Other Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00308802 |
| Other Study ID Numbers: |
DAIT CTOT-01 |
| First Posted: | March 30, 2006 Key Record Dates |
| Last Update Posted: | September 2, 2013 |
| Last Verified: | August 2013 |
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Kidney Transplant Rejection |
Kidney Disease Kidney Failure End Stage Renal Disease |