Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076570
Status:
COMPLETED
Last Update Posted:
2013-10-16
First Post:
2004-01-26
Brief Title:
Combination Drug Therapy Followed by Single Drug Steroid Free Therapy to Prevent Organ Rejection in Kidney Transplantation
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Depletion Induction With Rabbit Anti-Thymocyte Globulin Followed by Two Approaches Toward Monotherapy Immunosuppression in Kidney Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2013-08
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:
This study will test the safety and effectiveness of a combination of three drugs followed by long-term treatment with just one drug in preventing organ rejection in kidney transplant patients Current anti-rejection medicines are not completely effective in preventing rejection This trial will test how well Thymoglobulin Tacrolimus and Sirolimus work together post-transplant and if the treatment can be reduced over time to control rejection with either Tacrolimus or Sirolimus alone
Candidates for kidney transplantation at the National Institutes of Health Clinical Center may participate in this 5-year study Patients will be screened for eligibility with a medical history physical examination and blood tests
Participants will undergo the following tests and procedures
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 Thymoglobulin antibiotics and blood if needed The line is also used to collect blood samples
Leukapheresis This procedure for collecting white blood cells is done before the transplant The cells are studied to evaluate the patients immune system Whole blood is withdrawn through a catheter in an arm vein or through the central line and directed into a machine that separates the blood components by spinning The white cells are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
Kidney transplant Patients undergo kidney transplant surgery under general anesthesia
Immunosuppressive therapy Patients receive thymoglobulin by vein for 4 days starting 1 day before the transplant They also take Tylenol Benadryl and a steroid methylprednisolone to help reduce the side effects of the Thymoglobulin After the transplant patients receive Tacrolimus and Sirolimus by mouth once a day for 6 months and then either Tacrolimus or Sirolimus alone indefinitely In addition they take medicines to help prevent viral and fungal infections for 6 months because the immunosuppressive therapy leaves them vulnerable to infection
Follow-up visits After hospital discharge patients return to the Clinical Center twice a week for 4 weeks then every 6 months for 1 year and then yearly for another 4 years At each visit the patients vital signs are checked and blood and urine samples are collected Periodically patients are also questioned about how they feel and how the transplant has affected their quality of life Kidney biopsies removal of a small amount of kidney tissue through a thin needle are done when the patient begins single-drug immunosuppression generally 6 months after transplantation and 1 year after that The biopsied tissue is examined to evaluate how well the kidney is responding to the treatment and to determine how to proceed with therapy
Routine laboratory tests Routine tests coordinated by the patients local physician are done 2 to 3 times a week for the first 2 to 3 months after transplantation then weekly for several more months and at least monthly for life
Candidates for kidney transplantation at the National Institutes of Health Clinical Center may participate in this 5-year study Patients will be screened for eligibility with a medical history physical examination and blood tests
Participants will undergo the following tests and procedures
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 Thymoglobulin antibiotics and blood if needed The line is also used to collect blood samples
Leukapheresis This procedure for collecting white blood cells is done before the transplant The cells are studied to evaluate the patients 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
Kidney transplant Patients undergo kidney transplant surgery under general anesthesia
Immunosuppressive therapy Patients receive thymoglobulin by vein for 4 days starting 1 day before the transplant They also take Tylenol Benadryl and a steroid methylprednisolone to help reduce the side effects of the Thymoglobulin After the transplant patients receive Tacrolimus and Sirolimus by mouth once a day for 6 months and then either Tacrolimus or Sirolimus alone indefinitely In addition they take medicines to help prevent viral and fungal infections for 6 months because the immunosuppressive therapy leaves them vulnerable to infection
Follow-up visits After hospital discharge patients return to the Clinical Center twice a week for 4 weeks then every 6 months for 1 year and then yearly for another 4 years At each visit the patients vital signs are checked and blood and urine samples are collected Periodically patients are also questioned about how they feel and how the transplant has affected their quality of life Kidney biopsies removal of a small amount of kidney tissue through a thin needle are done when the patient begins single-drug immunosuppression generally 6 months after transplantation and 1 year after that The biopsied tissue is examined to evaluate how well the kidney is responding to the treatment and to determine how to proceed with therapy
Routine laboratory tests Routine tests coordinated by the patients local physician are done 2 to 3 times a week for the first 2 to 3 months after transplantation then weekly for several more months and at least monthly for life
Detailed Description:
This protocol facilitates the development of methods for determining whether transplant recipients have developed immune hyporesponsiveness or tolerance towards their allograft These methods will involve the study of peripheral blood or biopsy tissue obtained at regular intervals from patients receiving kidney or combined kidney-pancreas allografts at the NIH Clinical Center In addition patients that have previously received a kidney or combined kidney-pancreas allograft will be evaluated using assays requiring peripheral blood mononuclear cells andor biopsies Assays developed under this protocol will be used in subsequent protocols to assess the effects of immune modulating treatment regimens and may eventually be used to direct clinical care or guide the withdrawal of immunosuppressive agents However patients enrolled in this protocol will not have any change in treatment based solely on the assays developed without being enrolled in an additional study
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 |
|---|---|---|---|
| 04-DK-0099 | None | None | None |