Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00307125
Status:
COMPLETED
Last Update Posted:
2015-03-23
First Post:
2006-03-23
Brief Title:
Rituximab in Renal Allograft Recipients Who Develop Early De Novo Anti-HLA Alloantibodies
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
B-Cell Depletion by Anti-CD20 Rituximab in Renal Allograft Recipients Who Develop Early De Novo Anti-HLA Alloantibodies Will Result in Inhibition of Alloantibody Production and Attenuation of Chronic Humoral Rejection
Status:
COMPLETED
Status Verified Date:
2015-03
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:
The purpose of this study is to determine whether treatment with rituximab anti-CD20 Rituxan MabThera in individuals who develop new anti-HLA antibodies after renal kidney transplant will promote longer-term survival of the transplanted kidneyThe pilot study compares the use of rituximab Rituxan site-specific standard immunosuppression to placebo site-specific standard immunosuppression in the treatment of circulating anti-HLA antibodies in subjects who develop de novo anti-HLA antibodies between 3-36 months after transplant
Detailed Description:
Organ rejection occurs when a patients body does not recognize the new organ and attacks it Data suggest that the development of anti-human leukocyte antigen HLA antibodies is an early clinical indication that organ rejection may occur Rituximab is a genetically engineered monoclonal antibody directed against the CD20 antigen on B cells and is known to deplete B cells when administered intravenously it is FDA-approved for the treatment of non-Hodgkins lymphoma Chronic Lymphocytic Leukemia CLL and Rheumatoid Arthritis RA in combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies
In a previous small study kidney transplant patients with either acute humoral rejection AHR or chronic humoral rejection CHR were given rituximab and other antilymphocyte therapy Patients with AHR had lower or undetectable levels of circulating anti-HLA antibodies after study treatment and patients with CHR had a sustained decrease of anti-HLA antibodies to undetectable after 6 to 9 months
This study will evaluate the safety and efficacy of rituximab in 1preventing organ rejection and 2promoting long-term survival of donor kidneys in people who undergo kidney transplantation
This study involves two stages
1 Stage 1 begins 3 to 36 months after transplant During Stage 1 blood collection will occur every 3 months for up to 36 months after transplant to test for anti-HLA antibodies When these antibodies are detected twice within 1 month the patient will undergo a baseline kidney biopsy and have his or her glomerular filtration rate GFR measured to determine kidney function If a patient meets certain study criteria he or she will enter Stage 2 Pilot Treatment Study
If anti-HLA antibodies are not detected in a patients blood during Stage 1 the patients participation will be complete
2 In Stage 2 patients will receive site-specific standard immunosuppression plus randomization to either rituximab or placebo
Adult dosing 18 years of age will receive an intravenous infusion of 1000mg of rituximab on Days 0 and 14
Pediatric dosing than 18 years of age will receive an intravenous infusion of 375 mgm2dose maximum 500 mgdose in 4 doses of rituximab on Days 0 8 15 and 22
Adult participants will have 7-9 study visits over 12-24 months Pediatric participants will have 9-11 study visits over 12-24 months A physical exam medication history adverse events assessment and blood and urine collection will occur at all visits A biopsy of the kidney transplant will occur at Stage 2 entry and Month 12
Note Prior to January 2010 Stage 2 of this was a double-blind double-masked randomized pilot treatment study As of January 2010 and beyond
subjects were no longer being recruited in the placebo treatment arm
all treatment assignments were unblinded and an open-label design commenced therefore medication assignments were open to the study participants as well as to the site clinical team
all study subjects who participated in the study prior to this change were informed of the change
all subjects who were randomized to the placebo-controlled arm and continued to meet the pilot study eligibility criteria were provided the option to participate in the pilot treatment study
In a previous small study kidney transplant patients with either acute humoral rejection AHR or chronic humoral rejection CHR were given rituximab and other antilymphocyte therapy Patients with AHR had lower or undetectable levels of circulating anti-HLA antibodies after study treatment and patients with CHR had a sustained decrease of anti-HLA antibodies to undetectable after 6 to 9 months
This study will evaluate the safety and efficacy of rituximab in 1preventing organ rejection and 2promoting long-term survival of donor kidneys in people who undergo kidney transplantation
This study involves two stages
1 Stage 1 begins 3 to 36 months after transplant During Stage 1 blood collection will occur every 3 months for up to 36 months after transplant to test for anti-HLA antibodies When these antibodies are detected twice within 1 month the patient will undergo a baseline kidney biopsy and have his or her glomerular filtration rate GFR measured to determine kidney function If a patient meets certain study criteria he or she will enter Stage 2 Pilot Treatment Study
If anti-HLA antibodies are not detected in a patients blood during Stage 1 the patients participation will be complete
2 In Stage 2 patients will receive site-specific standard immunosuppression plus randomization to either rituximab or placebo
Adult dosing 18 years of age will receive an intravenous infusion of 1000mg of rituximab on Days 0 and 14
Pediatric dosing than 18 years of age will receive an intravenous infusion of 375 mgm2dose maximum 500 mgdose in 4 doses of rituximab on Days 0 8 15 and 22
Adult participants will have 7-9 study visits over 12-24 months Pediatric participants will have 9-11 study visits over 12-24 months A physical exam medication history adverse events assessment and blood and urine collection will occur at all visits A biopsy of the kidney transplant will occur at Stage 2 entry and Month 12
Note Prior to January 2010 Stage 2 of this was a double-blind double-masked randomized pilot treatment study As of January 2010 and beyond
subjects were no longer being recruited in the placebo treatment arm
all treatment assignments were unblinded and an open-label design commenced therefore medication assignments were open to the study participants as well as to the site clinical team
all study subjects who participated in the study prior to this change were informed of the change
all subjects who were randomized to the placebo-controlled arm and continued to meet the pilot study eligibility criteria were provided the option to participate in the pilot treatment 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 |
|---|---|---|---|
| CCTPT-02 | OTHER | NIAID | None |