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Column | Value |
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Trial registration number | ACTRN12621001412820 |
Full text link
Last imported at : Oct. 28, 2021, noon Source : International Clinical Trials Registry Platform (ICTRP) |
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First author
Last imported at : Oct. 28, 2021, noon Source : International Clinical Trials Registry Platform (ICTRP) |
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Contact
Last imported at : Oct. 28, 2021, noon Source : International Clinical Trials Registry Platform (ICTRP) |
Toby.Coates@sa.gov.au |
Registration date
Last imported at : Oct. 28, 2021, noon Source : International Clinical Trials Registry Platform (ICTRP) |
2021-10-20 |
Recruitment status
Last imported at : Oct. 28, 2021, noon Source : International Clinical Trials Registry Platform (ICTRP) |
Not recruiting |
Study design
Last imported at : Oct. 28, 2021, noon Source : International Clinical Trials Registry Platform (ICTRP) |
RCT |
Allocation
Last imported at : Oct. 28, 2021, noon Source : International Clinical Trials Registry Platform (ICTRP) |
Randomized |
Design
Last imported at : Oct. 28, 2021, noon Source : International Clinical Trials Registry Platform (ICTRP) |
Parallel |
Masking
Last imported at : Oct. 28, 2021, noon Source : International Clinical Trials Registry Platform (ICTRP) |
Blind label |
Center
Last imported at : Oct. 28, 2021, noon Source : International Clinical Trials Registry Platform (ICTRP) |
multi-center |
Study aim
Last imported at : Oct. 28, 2021, noon Source : International Clinical Trials Registry Platform (ICTRP) |
Prevention |
Inclusion criteria
Last imported at : Oct. 28, 2021, noon Source : International Clinical Trials Registry Platform (ICTRP) |
- Kidney transplant recipients - Aged 18-70 years - estimated GFR >25 mL/min - Spot urinary albumin:creatinine ratio <100 mg/µmol - Current immunosuppression regimen comprising tacrolimus, mycophenolate, prednisolone - Treating nephrologist agrees that patient is suitable for sirolimus maintenance immunosuppression - Have received 2 doses of a COVID-19 vaccine regimen (either adenoviral vector or mRNA-based) and have demonstrably not responded (anti-Receptor Binding Domain antibody titre < 100 U/mL) |
Exclusion criteria
Last imported at : Oct. 28, 2021, noon Source : International Clinical Trials Registry Platform (ICTRP) |
- Multi-organ transplant recipients (e.g. kidney-pancreas) - Aged <18 years or >70 years - Significant kidney dysfunction, estimated GFR =25 mL/min or spot urinary albumin:creatinine ratio =100 mg/µmol - Unable or unwilling to provide informed consent to participate in the trial - Have received 2 doses of a COVID-19 vaccine regimen (either adenoviral vector or mRNA-based) and have mounted an adequate immune response (anti-Receptor Binding Domain antibodies >100 U/mL) - Have had documented infection with COVID-19 - Known allergy to or intolerance of sirolimus or everolimus - Patients who are currently pregnant |
Number of arms
Last imported at : Oct. 28, 2021, noon Source : International Clinical Trials Registry Platform (ICTRP) |
2 |
Funding
Last imported at : Oct. 28, 2021, noon Source : International Clinical Trials Registry Platform (ICTRP) |
Professor P. Toby H Coates (MBBS FRACP PhD) |
Inclusion age min
Last imported at : Oct. 28, 2021, noon Source : International Clinical Trials Registry Platform (ICTRP) |
18 |
Inclusion age max
Last imported at : Oct. 28, 2021, noon Source : International Clinical Trials Registry Platform (ICTRP) |
70 |
Countries
Last imported at : Oct. 28, 2021, noon Source : International Clinical Trials Registry Platform (ICTRP) |
Australia |
Type of patients
Last imported at : Oct. 28, 2021, noon Source : International Clinical Trials Registry Platform (ICTRP) |
High risk patients |
Severity scale
Last imported at : Oct. 28, 2021, noon Source : International Clinical Trials Registry Platform (ICTRP) |
N/A |
Total sample size
Last imported at : Oct. 28, 2021, noon Source : International Clinical Trials Registry Platform (ICTRP) |
120 |
primary outcome
Last imported at : Oct. 28, 2021, noon Source : International Clinical Trials Registry Platform (ICTRP) |
Absolute proportion of patients in each arm meeting the threshold of 20.2% neutralising antibody required for clinical protection from SARS-CoV2 infection. Neutralising antibody titres will be assessed by dilution at which paCoV-2 live virus entry into angiotensin converting enzyme (ACE) 2 receptor positive cells by 50%. [4-6 weeks post-vaccination. During the intervening post-vaccination period patients will be clinically assessed once by phone 1 week post vaccination. Patients in the intervention group will also continue fortnightly immunosuppression level checks with phone call follow up for 6 weeks post-vaccination. ] |
Notes
Last imported at : Oct. 28, 2021, noon Source : International Clinical Trials Registry Platform (ICTRP) |
|
Phase
Last imported at : Oct. 28, 2021, noon Source : International Clinical Trials Registry Platform (ICTRP) |
Not reported |
Arms
Last imported at : Oct. 28, 2021, noon Source : International Clinical Trials Registry Platform (ICTRP) |
[{"arm_notes": "third dose;Have received 2 doses of a COVID-19 vaccine regimen (either adenoviral vector or mRNA-based)", "treatment_id": 2022, "treatment_name": "Bnt162b2+sirolimus", "treatment_type": "Rna based vaccine+immunosuppressants", "pharmacological_treatment": "Vaccine+pharmacological treatment"}, {"arm_notes": "third dose;Have received 2 doses of a COVID-19 vaccine regimen (either adenoviral vector or mRNA-based)", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}] |