Acute Graft Rejection, Chronic Allograft Nephropathy, Polyomavirus-related Transplant Nephropathy
Conditions
Keywords
rejection, survival, alemtuzumab, cyclosporine, tacrolimus
Brief summary
After alemtuzumab induction, followed with kidney transplantation, patients will be randomly assigned to receive either tacrolimus or cyclosporine microemulsion in combination with mycophenolates. Patients will be followed including protocol biopsy at 1, 12, 36, 60 month posttransplant, regular nuclein acid testing (NAT) for cytomegalovirus (CMV), Epstein-Barr virus (EBV) and BK virus (BKV) in urine and blood. The investigation is undertaken to clarify the reason for equal survival rates for patients on cyclosporine and tacrolimus despite the lower rejection rate on tacrolimus.
Detailed description
Special attention will be paid to the epidemiology of virus infections behind one year post transplant. Very limited data are available on this issue and there is suspicion that tacrolimus patients suffer more hard with viruses like CMV, EBV, BKV. These viruses can induce graft nephropathy and threat to the life of the recipient.
Interventions
after alemtuzumab, cyclosporine or tacrolimus was administered
Sponsors
Russian Scientific Center of Surgery
Russian Academy of Medical Sciences
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to 60 Years
Healthy volunteers
No
Inclusion criteria
* first kidney allograft recipients * alemtuzumab induction
Exclusion criteria
* CNI intolerance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Survival | 5 years | in cyclosporine group 96.4 +/- 2.8%; in tacrolimus group 96.3 +/- 3.4% |
| Graft Survival | 5 years | in cyclosporine group 84.6 +/- 5.8%; in tacrolimus group 86.2 +/- 4.1% |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cyclosporine Group cyclosporine group - after alemtuzumab induction cyclosporine was administered | 85 |
| Tacrolimus Group tacrolimus group - after alemtuzumab induction tacrolimus was administered
cyclosporine or tacrolimus: after alemtuzumab, cyclosporine or tacrolimus was administered | 85 |
| Total | 170 |
Baseline characteristics
| Characteristic | Cyclosporine Group | Tacrolimus Group | Total |
|---|---|---|---|
| Age, Continuous | 19 years STANDARD_DEVIATION 14 | 21 years STANDARD_DEVIATION 15 | 20 years STANDARD_DEVIATION 14 |
| Deceased donor kidney transplant recipients | 28 participants | 21 participants | 49 participants |
| Gender Female | 33 participants | 35 participants | 68 participants |
| Gender Male | 52 participants | 40 participants | 92 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 40 / 85 | 12 / 85 |
| serious Total, serious adverse events | 13 / 85 | 12 / 85 |
Outcome results
Primary
Graft Survival
in cyclosporine group 84.6 +/- 5.8%; in tacrolimus group 86.2 +/- 4.1%
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cyclosporine Group | Graft Survival | 84.6 percentage of participants |
| Tacrolimus Group | Graft Survival | 86.2 percentage of participants |
Primary
Patient Survival
in cyclosporine group 96.4 +/- 2.8%; in tacrolimus group 96.3 +/- 3.4%
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cyclosporine Group | Patient Survival | 96.4 percentage of participants |
| Tacrolimus Group | Patient Survival | 96.3 percentage of participants |