Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078559
Status:
COMPLETED
Last Update Posted:
2018-06-29
First Post:
2004-03-01
Brief Title:
Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
The Use of Campath-1H Tacrolimus and Sirolimus Followed by Sirolimus Withdrawal in Renal Transplant Patients
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Transplant rejection occurs when a patients body does not recognize the new organ and attacks it Patients who have kidney transplants must take drugs to prevent transplant rejection Alemtuzumab is a man-made antibody used to treat certain blood disorders The purpose of this study is to test the safety and effectiveness of using alemtuzumab in combination with two other drugs sirolimus and tacrolimus to prevent organ rejection after kidney transplantation This study will also test whether this combination of medications will allow patients to eventually stop taking antirejection medications entirely
Study hypothesis A new strategy of immunosuppression using alemtuzumab tacrolimus and sirolimus for human renal transplantation will permit a step-wise withdrawal from immunosuppressive drugs
Study hypothesis A new strategy of immunosuppression using alemtuzumab tacrolimus and sirolimus for human renal transplantation will permit a step-wise withdrawal from immunosuppressive drugs
Detailed Description:
Drugs that suppress the immune system such as sirolimus and tacrolimus 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 and these drugs make patients more susceptible to infection endangering their health and survival Regimens that are less toxic to or can eventually be withdrawn from transplant recipients are needed Alemtuzumab is a monoclonal antibody that binds to and depletes excess T cells in the bone marrow of leukemia patients This study will determine the effects of intravenous alemtuzumab and oral sirolimus and tacrolimus after kidney transplantation The study will also evaluate this regimens potential to allow eventual discontinuation of components of long-term immunosuppressive therapy
This study will last up to 4 years Participants will undergo kidney transplantation on Day 0 and will receive intravenous doses of alemtuzumab acetaminophen and diphenhydramine on Days 0 1 and 2 as well as methylprednisolone on Day 0 After transplant patients will receive up to 10 days of valganciclovir or acyclovir Participants will take tacrolimus daily by mouth for at least 60 days after transplant and sirolimus daily by mouth for at least 12 months after transplant As part of opportunistic infection OI prophylaxis participants will also take sulfamethoxazole-trimethoprim by mouth 3 times a week valganciclovir or acyclovir for up to 10 days post-transplant and clotrimazole or nystatin by mouth for at least 3 months post-transplant
There will be a minimum of 62 study visits spread out over 4 years after transplant Vital signs measurement adverse event and OI reporting medication history physical exam and blood collection will occur at selected visits Sirolimus withdrawal will begin when a participant meets certain study criteria The withdrawal process will occur over a minimum of 3 months at an approximate rate of 33 of the pre-withdrawal dose per month Participants eligible for sirolimus withdrawal will undergo several kidney biopsies including one 2 weeks prior to the start of withdrawal 6 and 12 months after completion of withdrawal 1 year after study enrollment and annually thereafter
This study will last up to 4 years Participants will undergo kidney transplantation on Day 0 and will receive intravenous doses of alemtuzumab acetaminophen and diphenhydramine on Days 0 1 and 2 as well as methylprednisolone on Day 0 After transplant patients will receive up to 10 days of valganciclovir or acyclovir Participants will take tacrolimus daily by mouth for at least 60 days after transplant and sirolimus daily by mouth for at least 12 months after transplant As part of opportunistic infection OI prophylaxis participants will also take sulfamethoxazole-trimethoprim by mouth 3 times a week valganciclovir or acyclovir for up to 10 days post-transplant and clotrimazole or nystatin by mouth for at least 3 months post-transplant
There will be a minimum of 62 study visits spread out over 4 years after transplant Vital signs measurement adverse event and OI reporting medication history physical exam and blood collection will occur at selected visits Sirolimus withdrawal will begin when a participant meets certain study criteria The withdrawal process will occur over a minimum of 3 months at an approximate rate of 33 of the pre-withdrawal dose per month Participants eligible for sirolimus withdrawal will undergo several kidney biopsies including one 2 weeks prior to the start of withdrawal 6 and 12 months after completion of withdrawal 1 year after study enrollment and annually thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| H-2003-0435 | OTHER | HS IRB | None |