Kidney Transplant
Conditions
Keywords
ABO incompatibility, living donor kidney transplant, kidney transplant, ABO blood type incompatible
Brief summary
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.
Detailed description
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.
Interventions
DRUGEculizumab
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.
Sponsors
Alexion Pharmaceuticals, Inc.
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be at least 18 years of age * Have end stage renal disease (ESRD) and is receiving a kidney transplant from a living donor to whom he/she has a baseline anti-blood group titer \>1:32 * Be vaccinated against N. meningitides (quadrivalent vaccine), H. Flu, and pneumococcal disease at least two weeks prior to beginning desensitization.
Exclusion criteria
* Has an unstable cardiovascular condition * Has had a previous splenectomy * Has any active bacterial or other infection * Has a known or suspected hereditary complement deficiency * Has known hypersensitivity to the treatment drug or any of its excipients * Has history of illicit drug use or alcohol abuse within the previous year * Has history of meningococcal disease * Has any medical condition that, in the opinion of the investigator, might interfere with the patient's participation in the study, pose an added risk for the patient, or confound the assessment of the patient (e.g. severe cardiovascular or pulmonary disease)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Subjects With Antibody-Mediated Rejection (AMR) Within 3 Months of Kidney Transplant | 3 months after kidney transplant surgery |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled from May 2010 to September 2012 at the Mayo Clinic in Rochester, Minnesota.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Eculizumab |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 6 |
| serious Total, serious adverse events | 5 / 6 |
Outcome results
Primary
Number of Subjects With Antibody-Mediated Rejection (AMR) Within 3 Months of Kidney Transplant
Time frame: 3 months after kidney transplant surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eculizumab | Number of Subjects With Antibody-Mediated Rejection (AMR) Within 3 Months of Kidney Transplant | Yes | 2 participants |
| Eculizumab | Number of Subjects With Antibody-Mediated Rejection (AMR) Within 3 Months of Kidney Transplant | No | 4 participants |