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| Name | Class |
|---|---|
| Russian Scientific Center of Surgery | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cyclosporine group | cyclosporine group - after alemtuzumab induction cyclosporine was administered |
| |
| tacrolimus group | tacrolimus group - after alemtuzumab induction tacrolimus was administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclosporine or tacrolimus | Drug | after alemtuzumab, cyclosporine or tacrolimus was administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Survival | in cyclosporine group 96.4 +/- 2.8%; in tacrolimus group 96.3 +/- 3.4% | 5 years |
| Graft Survival | in cyclosporine group 84.6 +/- 5.8%; in tacrolimus group 86.2 +/- 4.1% | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Recipients of kidney allograft who underwent previous Campath induction and do receive calcineurine inhibitor (CNI)
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| Name | Affiliation | Role |
|---|---|---|
| Michael M Kaabak, professor | Russian Scientific Center of Surgery RAMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Research Centre of Surgery | Moscow | 119992 | Russia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cyclosporine Group | cyclosporine group - after Campath induction cyclosporine will be administered |
| FG001 | Tacrolimus Group | tacrolimus group - after Campath induction tacrolimus will be administered |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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blood and urine, taken at the time of protocol or case biopsies will be deeply freeze and stocked for future examination for NAT or other molecules - candidates for diagnostic markers.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cyclosporine Group | cyclosporine group - after alemtuzumab induction cyclosporine was administered |
| BG001 | Tacrolimus Group | tacrolimus group - after alemtuzumab induction tacrolimus was administered cyclosporine or tacrolimus: after alemtuzumab, cyclosporine or tacrolimus was administered |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Gender | Number | participants |
| ||||||||||||||||
| Deceased donor kidney transplant recipients | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Survival | in cyclosporine group 96.4 +/- 2.8%; in tacrolimus group 96.3 +/- 3.4% | Posted | Number | 95% Confidence Interval | percentage of participants | 5 years |
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| |||||||||||||||||||||||||||||
| Primary | Graft Survival | in cyclosporine group 84.6 +/- 5.8%; in tacrolimus group 86.2 +/- 4.1% | Posted | Number | 95% Confidence Interval | percentage of participants | 5 years |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cyclosporine Group | cyclosporine group - after alemtuzumab induction cyclosporine was administered | 13 | 85 | 40 | 85 | ||
| EG001 | Tacrolimus Group | tacrolimus group - after alemtuzumab induction tacrolimus was administered cyclosporine or tacrolimus: after alemtuzumab, cyclosporine or tacrolimus was administered | 12 | 85 | 12 | 85 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| kidney graft loss | Renal and urinary disorders | Systematic Assessment |
| ||
| patient death | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| clinical acute rejection | Immune system disorders | Systematic Assessment | rejection accompanied by disturbances of the kidney graft function |
| |
| all rejection rate, including subclinical rejections. | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Michael Kaabak | Boris Petrovsky research cener od surgery | +74992481344 | kaabak@hotmail.com |
| ID | Term |
|---|---|
| D012059 | Rejection, Psychology |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Male |
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