drugset / Trial / NCT05022329
COVID-19 Vaccine Boosters in Patients With CKD
Phase 2/3
Terminated
273 enrolled
Sunnybrook Health Sciences Centre
Providence Healthcare · collabScarborough General Hospital · collabUnity Health Toronto · collabUniversity Health Network, Toronto · collab
RandomizedParallel-groupTriple-blindPrevention
Summary
This study is a 12-month, four-arm parallel-group randomized control trial of Pfizer-BioNTech versus MODERNA COVID-19 (Corona Virus disease 2019)vaccine boosters in chronic kidney disease and dialysis patients with poor humoral response following COVID-19 vaccination, in collaboration with 5 dialysis centers in Ontario and British Columbia, Canada . Patients will be randomized to MODERNA or Pfizer-BioNTech COVID-19 vaccine, they may have received either MODERNA or Pfizer-BioNTech COVID-19 vaccine for their initial two doses of vaccine, and will be stratified by their initial vaccine type (MODERNA or Pfizer-BioNTech ) prior to randomization, which will result in four study groups.
Timeline
- Start
- 2021-09-30
- Primary completion
- 2022-05-11
- Completion
- 2022-11-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BNT162b2 | Messenger RNA (mRNA) | 30 ug | — |
| Subject | Elasomeran | Messenger RNA (mRNA) | 100 ug | — |