Immunoglobulin A Nephropathy (IgAN), also known as Berger’s Disease, is a kidney problem where a protein called IgA builds up in the kidneys. Normally, IgA helps defend the body against infections, but in this case, it gets trapped in the kidneys and triggers inflammation, leading to potential damage over time.
Over time, this can lead to damage and scarring in the kidneys. If not treated or if the disease gets worse, it can lead to chronic kidney disease or even end-stage kidney disease (ESKD), where the kidneys stop working properly. In serious cases, patients may need dialysis or a kidney transplant to survive.
This randomised, double-blind, placebo-controlled trial will assess whether a medicine known as Ravulizumab can significantly reduce proteinuria and slow the decline of kidney function in adult patients with IgAN, a leading cause of kidney failure.
Ravulizumab is a medicine that helps calm down an overactive immune system. It blocks a part of the immune system that can cause inflammation and damage, especially in diseases like IgA Nephropathy. It’s given through a needle into the vein (intravenously) and lasts for about eight weeks between treatments.
This study, called ALXN1210-IgAN-320, will test whether the medicine Ravulizumab can reduce protein in the urine, a sign of kidney damage, and slow down the progression of kidney failure. The trial will follow patients over two years, with the main goals being to see improvements in kidney function and prevent serious kidney damage.
DBTH’s involvement highlights the hospital’s ongoing commitment to advancing clinical research and providing patients access to innovative treatments through the National Health Service (NHS).
NHS clinical research is pivotal in advancing medical knowledge, testing new treatments, and improving patient care. Clinical trials like this offer patients the chance to receive potentially life-saving therapies whilst contributing to cutting-edge medical science.
Gemma Rook, Clinical Research Sister at Doncaster and Bassetlaw Teaching Hospitals, shared her excitement about the hospital’s participation:
In addition to the placebo group, the study also includes a group where all participants know they’re receiving Ravulizumab. This group is being used to explore the safety and effectiveness of the drug in people with very low kidney function.
This important two-year study includes a six-week screening period, followed by 106 weeks of treatment, and a 98-week period where patients can continue receiving Ravulizumab.
For further information about this clinical trial or other ongoing studies at Doncaster and Bassetlaw Teaching Hospitals, please visit: https://www.dbth.nhs.uk/research-and-innovation/