None listed
Conditions
Brief summary
This is a phase 2, randomized, double-blind, placebo-controlled study of intravenous FDY-5301 in tourniquet induced sarcopenia in patients undergoing unilateral TKA. Study patients will be recruited at each investigational site (or referred to the investigative site from another institution) for first unilateral TKA. Patients will be screened and written informed consent will be obtained prior to initiation of any study related procedures in those patients who meet the inclusion and exclusion criteria for the study. A minimum of 30 evaluable patients will be enrolled and randomized to receive either FDY-5301 1.0mg/kg or volume-matched placebo. Study drug administration will occur by bolus injection at any time between 10 and 5 minutes prior to tourniquet release/limb reperfusion. All patients who receive study drug and have tourniquet use will be followed up for safety and efficacy for 6 weeks post-study drug administration.. Patients who do not undergo toirniquet inflation for any reason who received study drug will be followed up for safety, but will be replaced with a new patient.
Interventions
At least 30 evaluable patients will be enrolled to receive a single dose of 1.0 mg/kg FDY-5301 or placebo (n=15 per group) by bolus injection intra-operatively by the surgeon or medical team. Patients undergoing unilateral TKA with tourniquet use intra-operatively will receive either FDY-5301 or volume matched placebo after informed consent is obtained, provided the tourniquet has been inflated at least 40 minutes, within 5-10 minutes prior to tourniquet deflation and limb reperfusion. For each
At least 30 evaluable patients will be enrolled to receive a single dose of 1.0 mg/kg FDY-5301 or placebo (n=15 per group) by bolus injection intra-operatively by the surgeon or medical team. Patients undergoing unilateral TKA with tourniquet use intra-operatively will receive either FDY-5301 or volume matched placebo after informed consent is obtained, provided the tourniquet has been inflated at least 40 minutes, within 5-10 minutes prior to tourniquet deflation and limb reperfusion. For each participant, the study will consist of screening, total knee arthroplasty (TKA) and study drug treatment on day 1, evaluations on day 2, and follow-up visits at 3 weeks and 6 weeks after receiving the study drug All patients will have study outcomes monitored for 2 days and at 3 weeks and 6 weeks post operatively. Subject to the results in this cohort of patients, a decision will be made to proceed with more patients or other doses in future cohorts, or not.
Sponsors
Faraday Pharmaceuticals Australia PTY LTD
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
55 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
At least 30 patients 1. 55-85 year old male or female patients 2. Admitted for elective first total knee replacement surgery of one limb due to osteoarthritis. 3. Informed consent to study participation 4 Touniquet inflation for greater than or equal 40 minutes
Exclusion criteria
1. Anticipated tourniquet inflation for less than 40 minutes 2. Women of childbearing potential 3. Known contraindication to MRI (e.g. pacemaker) 4. Significant limb deformity as determined by the investigator, or prior lower limb osteotomy 5. Immediately post traumatic or Inflammatory arthritis of the operated limb 6. Patients with known thyroid disease, or known allergy to iodide 7. Patients with significant renal impairment (eGFR<50) 8. Body weight > 130 kg or Body Mass Index (BMI) > 40 kg/m2 9. Use of investigational drugs or devices within 30 days prior to enrollment into the study 10. Life expectancy of less than 1 year 11. Any clinically significant abnormality identified at the time of screening that in the judgment of the Investigator or any sub-Investigator would preclude safe completion of the study
Outcome results
None listed