Status:
COMPLETED
Anti-Viral Effects of Voclosporin in COVID-19 Positive Kidney Transplant Recipients
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Aurinia Pharmaceuticals Inc.
Conditions:
Covid19
Kidney Transplant Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Calcineurin inhibitors (CNIs) are general immunosuppressive agents commonly used in the setting of transplantation to prevent solid organ rejection. CNIs form the cornerstone of immunosuppressive trea...
Eligibility Criteria
Inclusion
- Provide written informed consent.
- Male or female subjects with a minimum age of 18 years at Visit 1.
- 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.
- 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.
- 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
- Subjects unable or unwilling to give written informed consent and/or to comply with study procedures.
- Any known hypersensitivity or contraindication to CNIs, especially CsA, or components of any cyclosporine drug product.
- 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.
- 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.
- 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.
- Subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions.
- 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.
- Subjects less than 3 months post-transplant.
- Subjects with documented organ rejection within the past 3 months.
- Subjects with a documented estimated glomerular filtration rate (eGFR) \<15 ml/min within the previous 3 months prior to screening.
Key Trial Info
Start Date :
November 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04701528
Start Date
November 15 2020
End Date
October 25 2022
Last Update
October 17 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Leiden University Medical Center
Leiden, Netherlands, 2333 ZC