End Stage Renal Disease
Conditions
Keywords
Renal, Transplant, PRA
Brief summary
The purpose of this study is to offer Panel Reactive Antibodies \[PRA\] reduction treatment to high responder renal transplant patients who otherwise may never be compatible with a potential organ donor. PRA reduction is offered in the following phases: 1. Immunological Testing 2. Transplant Nephrectomy 3. Pharmacologic Therapy 4. Plasmapheresis 5. Transplant
Detailed description
Patients with high level of preformed antibodies (panel reactive antibodies \[PRA\]) to donor antigens make identification of a suitable donor difficult. For most transplant centers, 20-35% of patients waiting for a kidney transplant comprise this challenging group. These patients have a wait time of over five years and have many incompatible cross-matches with potential organ donors.
Interventions
DRUGCMVIG
400mg/kg IV (60mg/kg/IV/hr initially, titrated up) once a week up to four weeks
Sponsors
CSL Behring
Tampa General Hospital
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
* Renal transplant recipients with a potential living donor who is incompatible (T-&/or B-cell locus) due to recipient high PRA or MHC antibodies * PRA greater than or equal to 20% within last twelve months * Recipient and donor accepted as potential candidates by the LifeLink Healthcare Renal Transplant Committee
Exclusion criteria
* Patients with known allergy to CytoGam(R), Cellcept, Rapamycin * Patients who will receive IVIG or CytoGam(R) for any cause prior to protocol process * ABO incompatibility * Patients not capable of following through the treatment for various reasons as determined by treating physicians * Any potential recipient who is pregnant or becomes pregnant * Exclusion for Plasmapheresis: known allergy to ethylene oxide or natural rubber latex. * Exclusion for Plasmapheresis: Intake of ACE-inhibitor or Angtiotensiin-receptor blockers in the last 24 hours prior to plasma exchange
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percent of Sensitized Patients Treated With PRA Reduction Pharmacological Therapy, Including Cytogam, Who Become Cross-match Compatible With Potential Living Donor | four weeks | The percent of sensitized patients treated with PRA Reduction Pharmacological Therapy, including Cytogam, who become cross-match compatible with potential living donor. Treatment success defined as achieving a decrease in donor specific antibody and eliminating cross-match incompatibility sufficient to allow transplantation. |
Secondary
| Measure | Time frame |
|---|---|
| Monitor Graft Survival | 5 years |
| Monitor Patient Survival | 5 years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Highly Sensitized Patients Highly-sensitized patients were defined as those having PRA \>/= 20% within the last 12 months; identification of donor-specific antibody or, any combination of Class I and/or Class 2 HLA incompatibility. | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | incomplete data | 6 |
Baseline characteristics
| Characteristic | Highly Sensitized Patients |
|---|---|
| Age, Continuous | 42 years STANDARD_DEVIATION 10.6 |
| Percent of subjects with PRA >/= 20% in last 12 months | 76 percent of subjects with elevated PRA |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
The Percent of Sensitized Patients Treated With PRA Reduction Pharmacological Therapy, Including Cytogam, Who Become Cross-match Compatible With Potential Living Donor
The percent of sensitized patients treated with PRA Reduction Pharmacological Therapy, including Cytogam, who become cross-match compatible with potential living donor. Treatment success defined as achieving a decrease in donor specific antibody and eliminating cross-match incompatibility sufficient to allow transplantation.
Time frame: four weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Highly Sensitized Patients | The Percent of Sensitized Patients Treated With PRA Reduction Pharmacological Therapy, Including Cytogam, Who Become Cross-match Compatible With Potential Living Donor | 40 percent of subjects becoming compatible |
Secondary
Monitor Graft Survival
Time frame: 5 years
Secondary
Monitor Patient Survival
Time frame: 5 years