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NCT00074516 · ClinicalTrials.gov registry record
Kidney Transplantation in Patients With Cystinosis
A clinical trial, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- 11
- Enrollment target
NCT00074516 is a clinical trial that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 11 participants.
The verdict
NCT00074516 has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- 11 participants
- Enrollment target
Study Summary
This study will test the effectiveness of a combination of anti-rejection medicines in preventing complications typically seen in cystinosis patients undergoing kidney transplants. Cystinosis is a rare disease affecting children that causes growth retardation and kidney failure. Kidney transplant is the standard treatment for kidney failure in these patients, followed by immunosuppression to prevent organ rejection. The standard drug regimen for immunosuppression includes steroids, which can lead to other serious complications. This study will look at combination therapy that does not include steroids. Patients 7 years of age and older with cystinosis who are candidates for a kidney transplant at the National Institutes of Health Clinical Center may be eligible for this 5-year study. Candidates will be screened with a medical history, physical examination, and blood tests. Participants will undergo the following tests and procedures: 1. Kidney transplant: Patients undergo kidney transplant surgery under general anesthesia. 2. Central line placement: A large intravenous catheter (plastic tube, or IV line) is placed in a vein in the chest or neck under local anesthesia before the transplant surgery. The line remains in place for some time during the hospitalization to administer immunosuppressive medications, antibiotics, and blood, if needed. The line is also used to collect blood samples. 3. Leukapheresis: This procedure for collecting white blood cells is done before the transplant. The cells are studied to evaluate the patient's immune system. Whole blood is withdrawn through a catheter in an arm vein or through the central line and directed into a machine that separates the blood components by spinning. The white cells are removed and the red cells and plasma are returned to the body. 4. Immunosuppressive medication following transplantation * Adults receive thymoglobulin at the time of the transplant and for 3 days after surgery; mycophenolate mofetil dai
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2003-12-10 |
| Est. Completion | 2014-06-11 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00074516
The ClinicalTrials.gov registry entry for NCT00074516 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00074516 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00074516 about?
NCT00074516 is a clinical study titled "Kidney Transplantation in Patients With Cystinosis". This study will test the effectiveness of a combination of anti-rejection medicines in preventing complications typically seen in cystinosis patients undergoing kidney transplants. Cystinosis is a rare disease affecting children that causes growth retardation and kidney failure. Kidney transplant is...
What is the current status of trial NCT00074516?
This trial is currently completed. The enrollment target is 11 participants. The study started on 2003-12-10. Estimated completion is 2014-06-11.
Who is sponsoring clinical trial NCT00074516?
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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