Noninvasive Methods to Monitor Graft Survival in Kidney Transplant Patients - NCT00308802-44195A (Clinical Trial 139148)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy139148.aspx
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| City: |
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Cleveland |
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State:
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OH |
| Zip Code: |
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44195 |
| Conditions: |
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Kidney Transplantation |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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 |
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| Study is available at: |
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Cleveland Clinic Foundation Cleveland, OH 44195 United States
Primary Contact: Leslie Iosue Email: iosuel@ccf.org Phone: 216-444-2991
Secondary Contact: Yvonne Morrison, MS Email: ymorrison@niaid.nih.gov Phone: 301-451-3139 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 3, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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