| Trial registration number
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TCTR20220404001 |
Full text link
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://www.thaiclinicaltrials.org/show/TCTR20220404001
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First author
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Athiphat Banjongjit
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Contact
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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athiphat_b@hotmail.com
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Registration date
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2022-04-04
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Recruitment status
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. Age >,= 18
2. Kidney transplant >, 6 months
3. Receiving MPA and CNI
4. Received 2 doses of ChAdOx1 nCoV-19 and 1 dose of BNT162b2 for 3-5 months
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Exclusion criteria
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
1. History of severe allergy from BNT162b2
2. Rejection within 6 months
3. High risk for rejection : ABO incompatible, multiorgan transplantation, previous transplantation, recent panel reactive antibody (PRA) >, 20% or donor specific antibody (DSA) positive
4. Pregnancy or lactation
5. Advanced stage cancer
6. AIDs
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Number of arms
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Division of nephrology; Department of Medicine; Faculty of Medicine; Chulalongkorn University
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Inclusion age min
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Thailand
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Type of patients
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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High risk patients
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Severity scale
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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N/A
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Total sample size
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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40
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primary outcome
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Anti-SARS-CoV-2 antibodies 1 month ELISA
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Notes
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 4
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Arms
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 2460, "treatment_name": "Mycophenolate mofetil+tacrolimus", "treatment_type": "Immunosuppressants", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2462, "treatment_name": "Mtor inhibitor+tacrolimus", "treatment_type": "Immunosuppressants", "pharmacological_treatment": "Pharmacological treatment"}]
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