Maintenance Versus Reduction of Immunosuppression for Renal Transplant Patients Hospitalized With COVID-19 Disease
- Conditions
- Kidney Transplant; ComplicationsImmunosuppressionCOVID
- Interventions
- Other: Maintenance or reduction of immunosuppression
- Registration Number
- NCT04420364
- Lead Sponsor
- Brigham and Women's Hospital
- 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-19 disease.
- 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 the rationale that such an approach will unleash the anti-viral T-cell response. However, on the other hand, some centers advocate there may be rationale to maintain baseline immunosuppression in order to mitigate against development of an uncontrolled over-activation of the immune response. The investigators propose to address this knowledge gap by performing a randomized clinical trial that will test formal comparisons of maintenance versus reduction in immunosuppression.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Reduction of Immunosuppression Maintenance or reduction of immunosuppression Reduction of immunosuppression (defined as anti-metabolite withdrawal plus reduction of tacrolimus or cyclosporin, to a minimum target trough concentration of 3 ng/mL for tacrolimus and 50 ng/mL for cyclosporin). Maintenance of Immunosuppression Maintenance or reduction of immunosuppression Maintenance of immunosuppression (defined as no change to pre-admission immunosuppression, or reduction in anti-metabolite by up to 50% (to a minimum of MMF 500 mg per day or azathioprine 50 mg per day)
- Primary Outcome Measures
Name Time Method Change in IL-6 concentration from baseline to day 7 baseline to day 7
- Secondary Outcome Measures
Name Time Method Length of hospital stay Through day 28 Change in IL-6 concentration from baseline to day 28 Baseline to day 28 Change in T cell response to SARS-CoV-2 Baseline to day 7 and day 28 Proportion of patients developing ANC < 500 cells per microliter Through day 28 Proportion of patients developing biopsy-proven acute rejection Through day 28 Adverse and serious adverse events Through day 28 In-hospital and 28-day mortality Through day 28 Change in COVID-19 disease severity score (range 1 to 8; higher worse) Through day 28 Proportion of patients needing non-invasive ventilation or intubation Through day 28 Proportion of patients developing lymphopenia < 400 cells per microliter Through day 28 Change in titer of serum anti-SARS-CoV-2 antibodies Baseline to day 7 and day 28
Related Research Topics
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