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| Column | Value |
|---|---|
| Trial registration number | NCT04961229 |
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Full text link
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
rutir@clalit.org.il |
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Registration date
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
2021-07-14 |
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Recruitment status
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
Not recruiting |
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Study design
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
inclusion criteria: kidney transplant recipients that received two doses of bnt162b2 vaccine at least 3 weeks prior to enrollment, and were seronegative (igg against the spike protein of sars-cov-2 below 50 au/ml) at least two weeks after the second vaccine dose additional inclusion criteria for the rct: recipients treated by three anti-rejection medications including: prednisone, tacrolimus, mycophenolate mofetil or mycophenolic acid. tacrolimus trough blood levels 5-10 ngr/ml (lower or higher doses will have to be adjusted before re-considering for inclusion) |
|
Exclusion criteria
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
past infection with sars-cov-2 pregnancy age below 18 years active infection additional exclusion criteria for rct only: - recipients at a high risk for acute or chronic humoral rejection including: recipients with positive panel-reactive antibody (pra) (any positive value) at any time before or after transplantation recipients that had an acute rejection in the last year recipients less than 6 months after transplantation recipients that are considered at high risk for rejection according to the primary care nephrologist recipients taking less than 3 anti-rejection medications recipients currently treated with mtor inhibitors (everolimus, sirolimus) and/or azathioprine recipients treated with plasmapheresis in the previous 3 months recipients treated with eculizumab in the last year recipient treated with ivig in the previous 3 months recipient treated with rituximab in the previous 6 months |
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Number of arms
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
dafna yahav |
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Inclusion age min
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
None |
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Type of patients
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
High risk patients |
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Severity scale
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : Oct. 11, 2021, 1 p.m. Source : ClinicalTrials.gov |
504 |
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primary outcome
Last imported at : Aug. 17, 2021, 6 p.m. Source : ClinicalTrials.gov |
anti-spike protein titer above 50 AU/ml 2 weeks post vaccination |
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Notes
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
Phase 4 |
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Arms
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Third dose of BNT162b2 vaccine with reduction of mycophenolic acid dose (immunosuppression reduction group)", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Third dose of BNT162b2 vaccine without reduction of mycophenolic acid dose (without immunosuppression reduction group)", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}] |