End Stage Renal Disease
Conditions
Brief summary
The purpose of this study is to test the clinical and laboratory observations of IVIG therapy in the highly sensitized patient. We will study the effects of patients treated with IVIG or Cytogam in combination with plasmaphoresis to modulate the immune response in highly sensitized patients. The goal is to convert a positive crossmatch to a compatible crossmatch that would allow living related transplant to take place or to shorten time on the transplant waiting list.
Detailed description
The purpose of this study is to test the clinical and laboratory observations of IVIG therapy in the highly sensitized patient. We will study the effects of patients treated with IVIG or Cytogam in combination with plasmaphoresis to modulate the immune response in highly sensitized patients. There are two arms in the study, one in which IVIG is administered to patients who have living donors with positive crossmatch results, and another in which intravenous immune globulin is administered to patients with no living donor and have a PRA greater than 30% for 3 consecutive months and a crossmatch with a cadaveric donor while on kidney transplant waiting list. The goal is to convert a positive crossmatch to a compatible crossmatch that would allow living related transplant to take place or to shorten time on the transplant waiting list.
Interventions
0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments
Sponsors
Loma Linda University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 12 years of age or older * diagnosed with end stage renal disease * currently receiving either hemodialysis or peritoneal dialysis * active on the kidney or kidney/pancreas transplant list * medical clearance of the kidney donor if live related transplant * elevated panel reactive antibody (PRA) greater that 30% for 3 consecutive monthly tests and one positive crossmatch with a cadaveric donor while on the transplant waiting list
Exclusion criteria
* received IVIG within 6 months prior to enrollment * HIV positive * Positive Hepatitis Be-antigen and/or hepatitis B viral DNA * Selective IgA deficiency or known antibodies to IgA * Allergy to human immune globulin * Pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Elimination of Donor Specific Antibodies | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Negative B and T Cell Crossmatch | 1year |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IVIG no Living Donor Intravenous immunoglobulin for: patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list | 14 |
| IVIG With Living Donor Intravenous immune globulin for patients who have living donors with positive crossmatch results. | 8 |
| Total | 22 |
Baseline characteristics
| Characteristic | IVIG no Living Donor | IVIG With Living Donor | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 8 Participants | 22 Participants |
| Sex/Gender, Customized Unknown | 14 participants | 8 participants | 22 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Elimination of Donor Specific Antibodies
Time frame: 1 year
Population: Study was terminated and no data for the outcome was collected/analyzed because it could not be located.
Secondary
Negative B and T Cell Crossmatch
Time frame: 1year
Population: Study was terminated and no data for the outcome was collected/analyzed because it could not be located.