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NCT00056784 · ClinicalTrials.gov registry record
The Role of Connective Tissue Growth Factor in the Development of Kidney Disease After Organ Transplantation
A clinical trial, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- 134
- Enrollment target
NCT00056784: Completed study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT00056784 is a clinical trial that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 134 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00056784 has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- 134 participants
- Enrollment target
Study Summary
This study will examine whether measurements of connective tissue growth factor (CTGF) and other cell proteins can identify which kidney transplant recipients are likely to develop chronic allograft nephropathy (CAN), a disease of the transplanted kidney. CAN may occur months to years after the transplant. The kidney becomes progressively scarred and eventually loses all function, so that dialysis or another transplant is needed. A better understanding of how CTGF and other proteins are involved in the development of CAN may provide new targets for treating for the disease. Patients who are scheduled to receive a kidney or combined kidney-pancreas transplant or who have received a transplant recently (within 6 months) may be eligible for this study. Participants will be enrolled before the transplant, if possible, or after the transplant, and will undergo the following tests and procedures: * Physical examinations at the screening visit, at 1, 6, 12, and 24 months, and then once yearly. * Blood sample collections at the screening visit, at 1, 6, 12, 18, and 24 months and then once yearly. * Urine sample collections at the screening visit, at 1, 6, 12, 18, and 24 months and then once yearly. * Kidney biopsies at the beginning of the study, at 1, 6, 12, and 24 months, and then once a year for research purposes. Participants may refuse to have a research biopsy at any time during the study. Also, patients who are having a kidney biopsy for another reason at these time points will not have a second biopsy. The biopsy procedure takes about 15 minutes and is done in the hospital. The patient lies on his or her back and the skin over the transplanted kidney is cleaned with alcohol and iodine. The area is numbed with an injection of an anesthetic, and then a biopsy needle is placed through the kin. The biopsy may be repeated up to three times to get enough tissue to test for CAN. Patients lie flat for 4 hours after the procedure to reduce the risk of bleeding, and are obs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2003-03-20 |
| Est. Completion | 2014-06-17 |
What the finished NCT00056784 record still lists
NCT00056784 is an observational study that tracks outcomes without assigning an intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00056784 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00056784 about?
NCT00056784 is a clinical study titled "The Role of Connective Tissue Growth Factor in the Development of Kidney Disease After Organ Transplantation". This study will examine whether measurements of connective tissue growth factor (CTGF) and other cell proteins can identify which kidney transplant recipients are likely to develop chronic allograft nephropathy (CAN), a disease of the transplanted kidney. CAN may occur months to years after the tran...
What is the current status of trial NCT00056784?
This trial is currently completed. The enrollment target is 134 participants. The study started on 2003-03-20. Estimated completion is 2014-06-17.
Who is sponsoring clinical trial NCT00056784?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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