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

NCT04420364 | Withdrawn Phase 2 DMC

• 1 other identifier: 2020P001516
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID; Kidney Transplant; Complications; Immunosuppression

Outcome Measures

Primary Outcomes (1)

• Change in IL-6 concentration from baseline to day 7

  baseline to day 7

Secondary Outcomes (11)

• 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

• Change in titer of serum anti-SARS-CoV-2 antibodies

  Baseline to day 7 and 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

Study Arms (2)

Maintenance of Immunosuppression

EXPERIMENTAL

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)

Other: Maintenance or reduction of immunosuppression

Reduction of Immunosuppression

ACTIVE COMPARATOR

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).

Other: Maintenance or reduction of immunosuppression

Interventions

Maintenance or reduction of immunosuppression OTHER

Maintenance versus reduction of immunosuppression

Maintenance of Immunosuppression; Reduction of Immunosuppression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

MeSH Terms

Interventions

Maintenance

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

• Jamil Azzi, MD, PhD

  Birgham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a single-blind trial, in that only the assessor will be blinded to the treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician

Model Details: Single-blind, parallel-group, randomized, active-controlled trial

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: May 3, 2021
• Primary Completion: May 4, 2021
• Study Completion: May 4, 2021
• Last Updated: May 4, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share