Kidney Failure
Conditions
Brief summary
Some patients who need kidney transplants have high levels of antibodies that make them incompatible with most potential deceased donor kidney offers. These patients are considered highly-sensitized and are very difficult to transplant because the likelihood that they will receive a compatible organ is very low. There are some medications and procedures that can decrease the antibody levels and this can increase the chance of finding a compatible donor for these patients. In this study the investigators will give two medications (IVIg and Rituximab) to highly-sensitized patients who are on the waiting list for a deceased donor kidney transplant. After the investigators administer these medications, the investigators will continue to check for compatibility as organ offers are received. If a compatible organ offer is received, the investigators will perform the transplant using that organ. The investigators hypothesize that these medications will lower antibody levels and increase the chance that a these patients are able to receive a compatible kidney transplant.
Interventions
A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses. If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA).
Sponsors
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Ages 18-75 * End-stage renal disease on dialysis * Panel Reactive Antibody (PRA) \> 60% * Have been evaluated for and are currently listed for deceased donor renal transplantation
Exclusion criteria
* Have contraindication to transplantation * Have contraindication to receiving IVIG * Have allergy to IVIG * Have received IVIG for desensitization previously without effect * Pregnant women or those intending to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Kidney Transplantation | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Decrease in Panel Reactive Antibody | 4 months |
Countries
United States
Participant flow
Recruitment details
20 participants were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| IvIg With Rituximab IVIg and rituximab: A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses.
If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA). | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | IvIg With Rituximab |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Time to Kidney Transplantation
Time frame: 4 months
Population: Data was not collected for this outcome measure. The study was terminated prematurely due to the P.I. leaving the institution.
Secondary
Decrease in Panel Reactive Antibody
Time frame: 4 months
Population: Data was not collected for this outcome measure. The study was terminated prematurely due to the P.I. leaving the institution.