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NCT00009009 · ClinicalTrials.gov registry record · Phase 2
Kidney Transplant for HIV-Infected Patients in Renal Failure
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT00009009 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 10 participants.
The verdict
NCT00009009, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
This study will examine the safety and effectiveness of renal (kidney) transplantation for HIV-infected patients with end-stage renal disease (kidney failure). Although kidney transplant is the best treatment for most causes of kidney failure, people infected with HIV are not offered this procedure because the immunosuppressive drugs (drugs that suppress immune function) required to prevent organ rejection could further impair the patient's already weakened immune system. This study will use a regimen of immunosuppressants designed to complement treatment for patients taking highly active antiretroviral therapy (HAART). HIV-infected patients between 18 and 60 years of age with renal failure who have not had any opportunistic infections for 5 years may be eligible for this study. Candidates will be screened with a medical history, physical examination, and blood and urine tests. Before the transplant procedure, participants will undergo additional tests and procedures, including blood studies, 24-hour urine collection, infectious disease consultation, tuberculin skin test, PAP smear for women, chest X-ray, brain and hip MRI studies and DEXA-scan to evaluate bone density. In addition, patients may undergo leukapheresis to obtain white blood cells for study. For this procedure, whole blood is drawn through a needle in an arm vein and passed through a cell separator machine. The white cells are collected for removal, and the rest of the blood is returned to the body through the same needle or another needle in the other arm. When a donor organ becomes available for transplant, the patient will receive three anti-rejection drugs-cyclosporine, mycophenolate mofetil and prednisone-to prevent organ rejection. Immediately after the surgery, HAART drugs will be stopped for 7 days until stable levels of the immune suppressants can be achieved. Then, HAART will be re-started and all medications will be adjusted to achieve adequate blood levels. Patients must stay in the loca
Interventions
- DRUG immunosuppressive regimen designed to complement HAART
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2001-01 |
| Est. Completion | 2002-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00009009
The ClinicalTrials.gov registry entry for NCT00009009 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 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 1 intervention - of which immunosuppressive regimen designed to complement HAART is the first listed.
NCT00009009 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00009009 about?
NCT00009009 is a clinical study titled "Kidney Transplant for HIV-Infected Patients in Renal Failure". This study will examine the safety and effectiveness of renal (kidney) transplantation for HIV-infected patients with end-stage renal disease (kidney failure). Although kidney transplant is the best treatment for most causes of kidney failure, people infected with HIV are not offered this procedure ...
What is the current status of trial NCT00009009?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2001-01. Estimated completion is 2002-12.
What interventions are being tested in trial NCT00009009?
The interventions under investigation include: immunosuppressive regimen designed to complement HAART (DRUG).
Who is sponsoring clinical trial NCT00009009?
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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