Maintenance Versus Reduction of Immunosuppression for Renal Transplant Patients Hospitalized With COVID-19 Disease

NCT ID: NCT04420364

Last Updated: 2022-05-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-03
• Study Completion Date: 2021-05-04

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.

Conditions

COVID; Kidney Transplant; Complications; Immunosuppression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Maintenance 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)

Group Type: EXPERIMENTAL

Maintenance or reduction of immunosuppression

Intervention Type: OTHER

Maintenance versus reduction of immunosuppression

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).

Group Type: ACTIVE_COMPARATOR

Maintenance or reduction of immunosuppression

Intervention Type: OTHER

Maintenance versus reduction of immunosuppression

Interventions

Maintenance or reduction of immunosuppression

Maintenance versus reduction of immunosuppression

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Finnian McCausland

Associate Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jamil Azzi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Birgham and Women's Hospital

Other Identifiers

2020P001516

Identifier Type: -

Identifier Source: org_study_id