| June 27, 2006 |
| May 13, 2009 |
| December 2006 |
| January 2011 (final data collection date for primary outcome measure) |
| Incidence of acute rejection at 6 months post-transplant [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] |
| Incidence of acute rejection at 6 months post-transplant |
| Complete list of historical versions of study NCT00346151 on ClinicalTrials.gov Archive Site |
- Graft and patient survival at 12, 24, 36, and 48 months post-transplant [ Time Frame: 12, 24, 36, and 48 months ] [ Designated as safety issue: Yes ]
- immunosuppressive-related and metabolic complications [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]
- tolerance induction [ Time Frame: 48 months ] [ Designated as safety issue: No ]
- laboratory measures predictive of tolerance or rejection [ Time Frame: 48 months ] [ Designated as safety issue: No ]
|
- Graft and patient survival at 12, 24, 36, and 48 months post-transplant
- immunosuppressive-related and metabolic complications
- tolerance induction
- laboratory measures predictive of tolerance or rejection
|
| |
| Belatacept to Prevent Organ Rejection in Kidney Transplant Patients |
| The Safety and Efficacy of Belatacept, Daclizumab, and Sirolimus in Recipients of Non-HLA-Identical Living-Donor Renal Transplants |
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can prevent the rejection of a first-time, non-HLA identical kidney transplant and allow patients to be safely withdrawn from anti-rejection therapy one year post-transplant. |
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. |
| Phase II |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
- Transplantation, Kidney
- End-Stage Renal Disease
|
- Drug: Belatacept
- Drug: Sirolimus
- Drug: Anti-thymocyte globulin
- Drug: methylprednisolone
|
| Experimental: Treatment arm |
| Vincenti F, Larsen C, Durrbach A, Wekerle T, Nashan B, Blancho G, Lang P, Grinyo J, Halloran PF, Solez K, Hagerty D, Levy E, Zhou W, Natarajan K, Charpentier B; Belatacept Study Group. Costimulation blockade with belatacept in renal transplantation. N Engl J Med. 2005 Aug 25;353(8):770-81. |
| |
| Active, not recruiting |
| 30 |
| July 2014 |
| January 2011 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Receiving first kidney transplant
- Transplant is from a non-HLA-identical living donor
- Willing to use acceptable forms of contraception
Exclusion Criteria:
- Positive for antihuman globulin (AHG) or T-cell cross-match with the donor.
- Receiving multiple-organ transplant
- History of cancer within the 5 years prior to study entry. Patients who have certain nonmelanoma skin cancers are not excluded.
- HIV infected
- Hepatitis B or C virus infected
- Other active infections
- Active tuberculosis infection within the 3 years prior to study entry
- Pregnancy or breastfeeding
|
| Both |
| 18 Years to 65 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00346151 |
| Associate Director, Clinical Research Program, DAIT/NIAID |
| DAIT ITN023ST |
| National Institute of Allergy and Infectious Diseases (NIAID) |
| Immune Tolerance Network |
| Principal Investigator: |
Flavio Vincenti, MD |
University of California, San Francisco |
|
| Principal Investigator: |
Christian Larsen, MD |
Emory University |
|
|
| National Institute of Allergy and Infectious Diseases (NIAID) |
| March 2009 |