Active Studies

Lakshman Gunaratnam

This Phase 2, global, multicenter, randomized, double-blinded, placebo-controlled trial evaluates the safety, tolerability, and efficacy of efgartigimod PH20 SC in kidney transplant recipients experiencing antibody-mediated rejection (AMR). Participants are randomized 1:1:1 to receive subcutaneous efgartigimod PH20 via prefilled syringe or placebo for a 48-week treatment period. All participants remain on standard background immunosuppression, including tacrolimus, mycophenolate mofetil, and steroids. The study monitors clinical outcomes and safety over a total duration of 78 weeks, including a 24-week observational follow-up period. The primary objective is to determine if neonatal Fc receptor (FcRn) inhibition effectively manages AMR in this patient population.

The pandemic continues to be hard for many transplant recipients and their families and caregivers. COVID-19 vaccines are less effective for transplant recipients. This is due to their suppressed immune systems. As a result, transplant recipients who get COVID-19 are at a higher risk of hospitalization and death. Preventing severe disease in transplant recipients requires different strategies. A New Study The CDTRP’s COVID-19 research is centered on addressing patient, family, and caregiver priorities. We have engaged the transplant community to learn how research and policy can support the recovery of quality of life during COVID-19 and in future health concerns A new study examines how COVID-19 continues to affect child and adult transplant recipients and their families and caregivers living in Canada. CDTRP will work with 11 transplant centres in Canada. The aim is to create a flexible national plan to inform better policies and improve patient health. The study is called Addressing Critical Issues and Therapeutics Emerging in Transplantation in COVID-19 for Transplant Recipients (TREAT-COVID). This study will: Assess the safety and effectiveness of COVID-19 treatment options. Look at the physical and mental health of organ and stem cell transplant recipients. Analyze financial struggles of the transplant community associated with the pandemic Patients and their families can help by joining research studies. The information gathered from the TREAT-COVID study will be used to improve treatment plans, guide important decisions, and help everyone better understand COVID-19 and its impact on their lives

Lakshman Gunaratnam

This Phase 2, randomized, double-blind, placebo-controlled trial evaluates the efficacy and safety of ALXN2030 in adult kidney transplant recipients with biopsy-proven active or chronic active antibody-mediated rejection (AMR). Participants are randomized 1:1:1 to receive ALXN2030 Dose A, ALXN2030 Dose B, or placebo for 52 weeks in addition to standard of care immunosuppression. The primary objective is to assess histologic resolution of AMR via repeat allograft biopsies at 28 and 52 weeks. Secondary outcomes include pharmacokinetics, immunogenicity, and long-term safety during a 52-week open-label extension.

This randomized, double-blind, pilot study evaluates the safety and efficacy of human milk oligosaccharides (HMO) in approximately 60 patients undergoing kidney transplantation. Participants receive either HMO prebiotic sachets or placebo for 12 weeks to determine if prebiotic therapy reduces delayed graft function and mitigates gastrointestinal side effects associated with post-transplant immunosuppression. The study monitors graft function through serial blood and urine samples, while microbiome changes are assessed via fecal analysis at six time points. Researchers utilize SF-36 and GI health questionnaires to measure quality of life and treatment tolerability over a six-month follow-up period. The primary objective is to determine if HMO-driven production of short-chain fatty acids improves the gut-kidney axis and stabilizes systemic inflammatory responses in this population.

Lakshman Gunaratnam

This single-center pilot study evaluates the safety and efficacy of alefacept in de novo kidney transplant recipients. The intervention combines alemtuzumab induction with alefacept, mycophenolic acid, and rapid withdrawal of both corticosteroids and calcineurin inhibitors. Alefacept is administered intravenously for two doses, followed by weekly subcutaneous injections through week 12 and monthly injections thereafter. Primary endpoints include the incidence of biopsy-proven acute rejection, infectious complications, and serious adverse events. Secondary outcomes focus on immune monitoring, specifically T-helper differentiation, cytokine production, and T-regulatory cell generation.

This phase 2b, non-randomized, open-label extension study evaluates the long-term persistence of immune response and the safety of revaccination with the adjuvanted RSVPreF3 vaccine. The target population includes adults ≥18 years of age who have undergone lung or kidney transplantation and are receiving chronic immunosuppressive therapy. Participants previously received either one or two doses of the vaccine in a parent study and now receive an additional dose to assess immunogenicity and safety profiles. Investigators analyze immune persistence separately based on prior dosing schedules while aggregating safety and demographic data across the revaccination cohort.

Matthew Weir

This Phase II-III multi-center randomized controlled trial evaluates whether urinary CXCL10 monitoring to detect and treat early subclinical rejection improves outcomes in adult renal transplant recipients. Patients with confirmed elevations in urinary CXCL10 between 2 weeks and 9 months post-transplant are randomized 1:1 to either an intervention arm or a standard-of-care control arm. The intervention group undergoes a renal biopsy for elevated CXCL10 levels, with biopsy-proven rejection treated per protocol, while the control group receives routine surveillance based on serum creatinine and proteinuria. All randomized participants undergo a protocol biopsy at 12 months to assess primary and long-term allograft outcomes.