Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR000135 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Poor enrollment
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Alexion Pharmaceuticals, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to try to determine if the drug eculizumab can help prevent antibody-mediated rejection in patients undergoing a kidney transplant from a living donor with a different blood type than their own.
Kidney transplantation is considered the best therapy for patients with end-stage renal disease. In some instances, the only suitable living kidney donor is ABO blood group incompatible. This usually presents a barrier to successful transplantation because most recipients have circulating serum antibodies that bind to incompatible blood groups that will bind and damage the kidney allograft early after transplantation. Fortunately, over the past decade, we and others have developed protocols involving the pretransplant removal of anti-blood group antibodies using multiple plasmapheresis treatments that allow for the successful transplantation of ABOi LDKTx. Thus, this therapy enables patients to receive a living donor with its advantages rather than having to wait >5 years for a deceased donor kidney.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eculizumab | Experimental | Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eculizumab | Drug | Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Antibody-Mediated Rejection (AMR) Within 3 Months of Kidney Transplant | 3 months after kidney transplant surgery |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark D Stegall | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
Not provided
Subjects were enrolled from May 2010 to September 2012 at the Mayo Clinic in Rochester, Minnesota.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Eculizumab | Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant. Eculizumab: Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Eculizumab | Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant. Eculizumab: Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Antibody-Mediated Rejection (AMR) Within 3 Months of Kidney Transplant | Posted | Number | participants | 3 months after kidney transplant surgery |
|
|
Adverse events were collected and recorded at each subject interface, up to one year after transplant.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eculizumab | Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant. Eculizumab: Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prolonged hospitalization | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
The study was terminated early due to poor enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark D. Stegall | Mayo Clinic | 507-266-2812 | stegall.mark@mayo.edu |
Not provided
| ID | Term |
|---|---|
| C481642 | eculizumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 5 |
| 6 |
| 1 |
| 6 |
| Native kidney mass | Renal and urinary disorders | Systematic Assessment |
|
| Native Nephrectomy | Renal and urinary disorders | Systematic Assessment | Native nephrectomy due to renal mass |
|
| Partial small bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Elevated creatinine | Renal and urinary disorders | Systematic Assessment |
|
| Splenectomy | Surgical and medical procedures | Systematic Assessment |
|
| Hyperkalemia | Cardiac disorders | Systematic Assessment |
|
| Elevated T- Waves | Cardiac disorders | Systematic Assessment |
|
| Ogilvie's syndrome | Gastrointestinal disorders | Systematic Assessment |
|
| Allograft Nephrectomy | Renal and urinary disorders | Systematic Assessment |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Moved to intensive care unit for 24 hours for monitoring |
|
| Antibody-mediated rejection of transplant | Renal and urinary disorders | Systematic Assessment |
|
| Wound dehiscence with cecal rupture | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Right hemicolectomy | Surgical and medical procedures | Systematic Assessment |
|
| Wound debridement | Surgical and medical procedures | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Platelet dysfunction | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombotic microangiopathy | Renal and urinary disorders | Systematic Assessment |
|
| Pulmonary Blastomycosis | Infections and infestations | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| High-volume serous drainage from surgery incision site | Surgical and medical procedures | Systematic Assessment |
|
| Wound infection | Infections and infestations | Systematic Assessment |
|
| Lymphocele | Surgical and medical procedures | Systematic Assessment |
|
| Debilitation | General disorders | Systematic Assessment | Due to prolonged hospitalization |
|
Not provided
Not provided
Not provided