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

• Status: Recruiting
• Trial end date: 2022-10-25
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leiden University Medical Center
• Collaborator: Aurinia Pharmaceuticals Inc.
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

1. Provide written informed consent.

2. Male or female subjects with a minimum age of 18 years at Visit 1.

3. Subjects with a stable kidney transplant taking TAC and a confirmed diagnosis of SARS-CoV-2 by nuclear acid testing, with mild-to-moderate symptoms.

4. Patients with mild-to-moderate disease symptoms in which mild disease is defined by non-hospitalized patients without oxygen need and moderate disease symptoms are defined by hospitalization to a nursing ward with the need of oxygen therapy.

5. Women of childbearing potential must have a negative pregnancy test at baseline. Two effective forms of contraception must be used simultaneously unless abstinence is the chosen method. Subjects must use effective contraception during the study.

Exclusion Criteria:

1. Subjects unable or unwilling to give written informed consent and/or to comply with study procedures.

2. Any known hypersensitivity or contraindication to CNIs, especially CsA, or components of any cyclosporine drug product.

3. Current or medical history of:

• Congenital immunodeficiency.

• Severe, known, active viral infections, excluding SARS-CoV-2, within 3 months of baseline (e.g., cytomegalovirus, hepatitis B virus, hepatitis C virus or HIV) that are deemed to interfere with study assessments or outcome according to Investigator's judgement.

4. Severe symptoms resulting from SARS-CoV-2 infection defined by requiring admittance to a medium or high care unit with the need for positive pressure ventilation at baseline.

5. Other major physical or psychiatric illness or major traumatic injury or any other medical condition associated with increased risk to the subject or that may affect study conduct or interfere with study assessments or outcome according to Investigator's judgement.

6. Subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions.

7. Participation in another interventional clinical study within 4 weeks prior to baseline and/or receipt of investigational drugs within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to baseline.

8. Subjects less than 3 months post-transplant.

9. Subjects with documented organ rejection within the past 3 months.

10. Subjects with a documented estimated glomerular filtration rate (eGFR) <15 ml/min within the previous 3 months prior to screening.