COVIDPhase 2/3NCT04420364
Maintenance Versus Reduction of Immunosuppression for Renal Transplant Patients Hospitalized With COVID-19 Disease
A Phase 2/3 study testing Maintenance or reduction of immunosuppression in people with COVID and Kidney Transplant; Complications, run by Brigham and Women's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Kidney Transplant; Complications, Immunosuppression
- What is being tested?
- Maintenance or reduction of immunosuppression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 3 May 2021to 4 May 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
About this study
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.
Read the 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
- Being tested
- Maintenance or reduction of immunosuppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maintenance or reduction of immunosuppressionOther
Maintenance versus reduction of immunosuppression
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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). Receives: Other: Maintenance or reduction of immunosuppression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IL-6 concentration from baseline to day 7
Measured: baseline to day 7
Secondary outcomes (11)
Change in IL-6 concentration from baseline to day 28
Measured: Baseline to day 28
Change in T cell response to SARS-CoV-2
Measured: Baseline to day 7 and day 28
Change in titer of serum anti-SARS-CoV-2 antibodies
Measured: Baseline to day 7 and day 28
Change in COVID-19 disease severity score (range 1 to 8; higher worse)
Measured: Through day 28
Proportion of patients needing non-invasive ventilation or intubation
Measured: Through day 28
Proportion of patients developing ANC < 500 cells per microliter
Measured: Through day 28
Proportion of patients developing lymphopenia < 400 cells per microliter
Measured: Through day 28
Length of hospital stay
Measured: Through day 28
Proportion of patients developing biopsy-proven acute rejection
Measured: Through day 28
In-hospital and 28-day mortality
Measured: Through day 28
Adverse and serious adverse events
Measured: Through day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start3 May 2021
- Primary completion4 May 2021
- Study completion4 May 2021
Why it stopped: Decline in COVID cases
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind, parallel-group, randomized, active-controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Finnian McCausland, Brigham and Women's Hospital
- Investigators
- Jamil Azzi, MD, PhD, Principal investigator, Birgham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420364
- Sponsor's protocol ID
- 2020P001516
- Status last verified
- May 2022
- First submitted
- 4 Jun 2020
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Versus Reduction of Immunosuppression for Renal Transplant Patients Hospitalized With COVID-19 Disease
- ClinicalTrials.gov ID
- NCT04420364
- Acronym / sponsor ID
- 2020P001516
- Conditions
- COVID, Kidney Transplant; Complications, Immunosuppression
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Decline in COVID cases
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blind, parallel-group, randomized, active-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Maintenance of Immunosuppression | Experimental | Other: Maintenance or reduction of immunosuppressionMaintenance 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) |
| Reduction of Immunosuppression | Active comparator | Other: Maintenance or reduction of immunosuppressionReduction 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maintenance or reduction of immunosuppressionMaintenance versus reduction of immunosuppression | Other | Maintenance of Immunosuppression, Reduction of Immunosuppression |
Primary outcome
Change in IL-6 concentration from baseline to day 7
Time frame: baseline to day 7
11 secondary outcomes
Change in IL-6 concentration from baseline to day 28
Time frame: Baseline to day 28
Change in T cell response to SARS-CoV-2
Time frame: Baseline to day 7 and day 28
Change in titer of serum anti-SARS-CoV-2 antibodies
Time frame: Baseline to day 7 and day 28
Change in COVID-19 disease severity score (range 1 to 8; higher worse)
Time frame: Through day 28
Proportion of patients needing non-invasive ventilation or intubation
Time frame: Through day 28
Proportion of patients developing ANC < 500 cells per microliter
Time frame: Through day 28
Proportion of patients developing lymphopenia < 400 cells per microliter
Time frame: Through day 28
Length of hospital stay
Time frame: Through day 28
Proportion of patients developing biopsy-proven acute rejection
Time frame: Through day 28
In-hospital and 28-day mortality
Time frame: Through day 28
Adverse and serious adverse events
Time frame: Through day 28
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamil Azzi, MD, PhD principal investigator
Birgham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Maintenance or reduction of immunosuppression in people with COVID and Kidney Transplant; Complications, run by Brigham and Women's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IL-6 concentration from baseline to day 7 (time frame: baseline to day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.