SARS-CoV-2 infection in Kidney Transplant Recipients MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 21.1 Level: LLT Classification code 10052212 Term: Organ transplant NOS System Organ Class: 100000004865
Conditions
Interventions
Product Name: Voclosporin or Lupkynis
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Voclosporin
CAS Number: 515814-01-4
Current Sponsor code: ISA247
Other descriptive name: VOCLOSPORIN
Conce
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provide written informed consent, in accordance with EMA guidance on the management of clinical trials during COVID-19 pandemic (Version 2, 27 March 2020). If written consent by the trial participant is not possible (for example because of physical isolation due to COVID-19 infection), consent could be given orally by the trial participant (Art 2(j) of Directive 2001/20/EC) in the presence of an impartial witness. In such cases, the witness is required to sign and date the informed consent document and the Investigator is expected to record how the impartial witness was selected. 2. Male or female subjects with a minimum age of 18 years (or legal age of consent if =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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 requiring 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the anti-viral effects of voclosporin compared to standard of care with tacrolimus on SARS-CoV-2 over 28 days in stable Kidney Transplant Recipients ;Secondary Objective: To assess the safety and tolerability of voclosporine in stable Kidney Transplant Recipients infected with SARS-CoV-2;Primary end point(s): The main endpoint is the reduction in SARS-CoV-2 viral load over 28 days, as measured by quantitative reverse transcription polymerase chain reaction (RT-qPCR). ;Timepoint(s) of evaluation of this end point: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Assess surrogate markers of (improved) viral clearance • Assess safety and tolerability ;Timepoint(s) of evaluation of this end point: 28 days up to 1 year | — |
Countries
Netherlands
Contacts
Public ContactDr. Y.K.O. Teng
Leiden University Medical Center
Outcome results
None listed