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| Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Immune Tolerance Network |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00346151 |
Purpose
Belatacept is an experimental medication shown in clinical trials to have immune system suppression properties in people who have had kidney transplants.
This study will determine whether a combination of anti-rejection drugs, including belatacept, can prevent the rejection of a first-time, non-HLA identical kidney transplant and allow patients to be safely withdrawn from anti-rejection therapy one year post-transplant.
| Condition | Intervention | Phase |
|---|---|---|
|
Transplantation, Kidney End-Stage Renal Disease |
Drug: Belatacept Drug: Sirolimus Drug: Anti-thymocyte globulin Drug: methylprednisolone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | The Safety and Efficacy of Belatacept, Daclizumab, and Sirolimus in Recipients of Non-HLA-Identical Living-Donor Renal Transplants |
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Treatment arm
|
Drug: Belatacept
10 mg/kg IV on transplant (day 1), day 5, and at weeks 2, 4, 8 and 12, then 5 mg/kg IV every 4 weeks
Drug: Sirolimus
4 mg/day on transplant, then dose adjust to maintain 8-12 ng/mL for at least 1 year
Drug: Anti-thymocyte globulin
1.5 mg/kg IV daily on transplant (day 1) through day 4
Drug: methylprednisolone
500 mg IV at transplant (day 1), then 250 mg IV on day 2 and 0.5 mg/kg IV or prednisone 0.5 mg/kg PO on days 3 and 4
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Drugs that suppress the immune system, have contributed to increased success of transplantation. However, to prevent organ rejection, transplant recipients need to take immunosuppressive drugs for the rest of their lives; these drugs make patients more susceptible to infection and certain kinds of cancer. Belatacept is an experimental medication that specifically targets immune reactions against transplanted organs and has been shown to be effective in preventing kidney transplant rejection in previous clinical trials. Both thymoglobulin, an antibody, and sirolimus, an anti-rejection drug, prevent rejection by lowering the response of the immune system to the transplanted organ. .This study will evaluate whether belatacept, along with thymoglobulin and sirolimus, is safe in kidney transplant patients. The study will also evaluate this regimen's potential to allow tapering and eventual discontinuation of all immunosuppressive drugs.
This study will last up to 4 years. At the time of transplant, participants will begin a medication schedule consisting of thymoglobulin, sirolimus, and belatacept. Participants will receive infusions of thymoglobulin on days 1 though , and a combination of oral sirolimus (daily) and belatacept infusions at day 5, then weeks 2, 4, 8, and monthly for at least 2 years. Dose reduction of belatacept will occur at 12 weeks post-transplant. At Year 2, eligible participants may choose to begin drug withdrawal or continue study therapy through the end of the study. Study visits will occur weekly for the first two months, then monthly. These visits will include belatacept treatment, general medical assessments, blood and urine collection, and other assessments to determine overall health of the recipient's immune system and kidney transplant and to better understand the way the immune system works in the acceptance or rejection of organ transplants.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94143 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| Principal Investigator: | Flavio Vincenti, MD | University of California, San Francisco |
| Principal Investigator: | Christian Larsen, MD | Emory University |
More Information
| Responsible Party: | DAIT/NIAID ( Associate Director, Clinical Research Program ) |
| Study ID Numbers: | DAIT ITN023ST |
| Study First Received: | June 27, 2006 |
| Last Updated: | May 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00346151 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
Kidney Transplant Kidney Transplantation Renal Transplant Transplantation Renal Transplantation |
Kidney Failure Renal Failure Kidney Disease Renal Disease Living Donor |
|
Sirolimus Anti-Inflammatory Agents Prednisone Renal Insufficiency Immunologic Factors Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Kidney Failure, Chronic Benzocaine Antiemetics Prednisolone acetate Neuroprotective Agents Hormones Anti-Bacterial Agents |
Abatacept Urologic Diseases Antifungal Agents Kidney Diseases Methylprednisolone Hemisuccinate Antineoplastic Agents, Hormonal Daclizumab Methylprednisolone acetate Immunosuppressive Agents Glucocorticoids Antilymphocyte Serum Renal Insufficiency, Chronic Prednisolone Peripheral Nervous System Agents Antirheumatic Agents |
|
Sirolimus Anti-Inflammatory Agents Anti-Infective Agents Renal Insufficiency Immunologic Factors Antineoplastic Agents Methylprednisolone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Kidney Failure, Chronic Antiemetics Prednisolone acetate Antibiotics, Antineoplastic Hormones Neuroprotective Agents |
Anti-Bacterial Agents Abatacept Urologic Diseases Antifungal Agents Therapeutic Uses Kidney Diseases Methylprednisolone Hemisuccinate Antineoplastic Agents, Hormonal Gastrointestinal Agents Methylprednisolone acetate Glucocorticoids Protective Agents Immunosuppressive Agents Pharmacologic Actions Antilymphocyte Serum |
