Status:
WITHDRAWN
Maintenance Versus Reduction of Immunosuppression for Renal Transplant Patients Hospitalized With COVID-19 Disease
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
COVID
Kidney Transplant; Complications
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This will be a randomized trial of maintenance versus reduction in immunosuppression in adult patients (age \>18 years old) with functioning renal transplants admitted to hospital with confirmed COVID...
Detailed Description
The optimal management of immunosuppression in renal transplant patients with COVID-19 disease is unclear. On one hand, many centers advocate reduction of immunosuppression in infected patients, with ...
Eligibility Criteria
Inclusion
- Adults ≥18 years
- COVID positive by RT-PCR or serology
- ≥ 6 months post-transplant
- use of anti-metabolite (mycophenolate or azathioprine) and calcineurin inhibitor (cyclosporin or tacrolimus)
- informed consent; first admission during study period
- participation within 72 hours of hospitalization
Exclusion
- ICU care or need for invasive ventilation or use of pressors at screening/randomization
- COVID-19 disease severity score more than 5 at screening/randomization
- Known donor specific antibody
- eGFR \<20ml/min/1.73m2
- hematocrit \<24%
- biopsy proven and treated rejection within last 3 months
- institutionalized individuals (prisoners)
- pregnancy
- participation in another clinical study with an investigational medicinal product within 30 days or within 5 half-lives of such, whichever is longer, prior to randomization and during the study
- any other conditions, which, in the opinion of the investigator would make the subject unsuitable.
Key Trial Info
Start Date :
May 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04420364
Start Date
May 3 2021
End Date
May 4 2021
Last Update
May 4 2022
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