Anti-Viral Effects of Voclosporin in COVID-19 Positive Kidney Transplant Recipients

Sponsor
Leiden University Medical Center
Study ID
NCT04701528
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Voclosporin — DRUG
    Temporarily switching of tacrolimus maintenance immunosuppression to voclosporin maintenance immunosuppression with possible additional anti-viral activity
  • Tacrolimus — DRUG
    Comparator

Study Details

An open-label, 56 day, single-center, exploratory, proof-of-concept study of the anti-viral effect of voclosporin (VCS) with an extended safety follow-up, up to 1 year. Study population are adult KTRs with positive SARS-CoV-2 infection with mild to moderate symptoms. At study entry, subjects are on standard therapy of dual immunosuppressive treatment of prednisone and tacrolimus (TAC), following randomization, 10 out of 20 subjects will remain on this therapy for the duration of the study, while the other 10 subjects will switch to VCS.

Key Dates

Start date
Nov 15, 2020
Status verified
Oct 2024
Primary completion
Mar 25, 2022
Completion
Oct 25, 2022

Study Design

Enrollment
20 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Voclosporin (VCS)
    Prior to or at study entry, subjects are reduced in their standard immunosuppressive therapy to dual therapy with prednisone and tacrolimus according to current local guidelines. In the experimental arm tacrolimus is switched to voclosporin 6 capsules (of 7.9 mg each) BID for a treatment period of minimal 56 days with a possible extension up to 1 year. Safety drug monitoring will take place during the study to ensure that VCS trough levels are maintained between 30-60 ng/mL. If trough levels are not within these levels, dose adjustments will take place.
  • Active Comparator: Tacrolimus (TAC)
    Prior to or at study entry, subjects are reduced in their standard immunosuppressive therapy to dual therapy with prednisone and tacrolimus according to current local guidelines. In the Active comparator arm tacrolimus dosage is maintained. Safety drug monitoring will take place during the study to ensure that TAC trough levels are maintained between 3-7 ng/ml. If trough levels are not within these levels, dose adjustments will take place.

Primary Outcome Measure

Time to viral clearance of SARS-CoV-2 [ Time Frame: Day 56 ]

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