An observational study in Acute Graft Rejection, Chronic Allograft Nephropathy and Polyomavirus-related Transplant Nephropathy, sponsored by Russian Academy of Medical Sciences. Completed at 1 site in Russian Federation. Open to participants aged 6 Months to 60 Years. Per ClinicalTrials.gov, last updated 2016-11-29.
Sponsored by Russian Academy of Medical Sciences · Observational
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.
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 170 is below the median of 192 across 1,033 observational studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Russian Academy of Medical Sciences is the lead sponsor of 34 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Recipients of kidney allograft who underwent previous Campath induction and do receive calcineurine inhibitor (CNI)
Exclusion Criteria:
cyclosporine group - after alemtuzumab induction cyclosporine was administered
Drug: cyclosporine or tacrolimus
tacrolimus group - after alemtuzumab induction tacrolimus was administered
Drug: cyclosporine or tacrolimus
after alemtuzumab, cyclosporine or tacrolimus was administered
Patient Survival
in cyclosporine group 96.4 +/- 2.8%; in tacrolimus group 96.3 +/- 3.4%
Time frame: 5 years
Graft Survival
in cyclosporine group 84.6 +/- 5.8%; in tacrolimus group 86.2 +/- 4.1%
Time frame: 5 years
| Milestone | Cyclosporine Group | Tacrolimus Group |
|---|---|---|
| Started | 85 | 85 |
| Completed | 85 | 85 |
| Not completed | 0 | 0 |
in cyclosporine group 96.4 +/- 2.8%; in tacrolimus group 96.3 +/- 3.4%
| percentage of participants | Cyclosporine Group | Tacrolimus Group |
|---|---|---|
| Patient Survival | 96.4 (94 to 98.8) | 96.3 (92.9 to 99.7) |
in cyclosporine group 84.6 +/- 5.8%; in tacrolimus group 86.2 +/- 4.1%
| percentage of participants | Cyclosporine Group | Tacrolimus Group |
|---|---|---|
| Graft Survival | 84.6 (78.7 to 90.5) | 86.2 (82.6 to 93.5) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cyclosporine Group | — | 13/85 (15.3%) | 40/85 (47.1%) |
| Tacrolimus Group | — | 12/85 (14.1%) | 12/85 (14.1%) |
| Event | Cyclosporine Group | Tacrolimus Group |
|---|---|---|
| kidney graft lossRenal and urinary disorders | 9/85 | 9/85 |
| patient deathCardiac disorders | 4/85 | 3/85 |
| Event | Cyclosporine Group | Tacrolimus Group |
|---|---|---|
| all rejection rate, including subclinical rejections.Renal and urinary disorders | 40/85 | 12/85 |
| clinical acute rejectionImmune system disorders | 30/85 | 7/85 |
| Age, Continuous(years) | Cyclosporine Group | Tacrolimus Group | Total |
|---|---|---|---|
| Mean | 19 ± 14 | 21 ± 15 | 20 ± 14 |
| Gender(participants) | Cyclosporine Group | Tacrolimus Group | Total |
|---|---|---|---|
| Female | 33 | 35 | 68 |
| Male | 52 | 40 | 92 |
| Deceased donor kidney transplant recipients(participants) | Cyclosporine Group | Tacrolimus Group | Total |
|---|---|---|---|
| Number | 28 | 21 | 49 |
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Russian Academy of Medical Sciences