First UK child takes part in kidney research trial
The first child in the UK has participated in an international research trial taking place at Royal Manchester Children’s Hospital (RMCH).
Korbin Wake, 13, was recruited to the Sodium Zirconium Cyclosilicate (SZC) trial for the correction of hyperkalaemia, by Dr Dean Wallace, a Paediatric Nephrologist at RMCH, who cares for children like Korbin, who have kidney conditions.
Dr Wallace is the MFT Principal Investigator (PI) for this trial, meaning he is leading the study at our Trust.
“This is a new children’s clinical trial of a medication that has been demonstrated to effectively control high potassium levels, or hyperkalaemia, in adult patients,” said Dr Wallace.
One of the issues we see in children with kidney conditions is that excessive potassium can build up in the bloodstream as a result of kidney disease itself, or as a side effect of the medications used to slow down the development of chronic kidney disease.
Potassium is an electrolyte (salt) that we get from our diet and is something we all need, since it has a vital role in cell and muscle functioning. The blood levels are kept under tight control by the kidneys that excrete excess levels in the urine. Advanced kidney disease interrupts this process and excess levels can lead to serious cardiac adverse events, such as arrhythmias and arrest.
“Mostly, mildly elevated potassium levels can be controlled with dietary restrictions of potassium-rich foods, such as bananas, chocolate, potatoes, strawberries and tomatoes,” said Dr Wallace.
“We anticipate that this medication could be useful for some of the children we see with more severe kidney conditions, as it can directly bind potassium in the gut before it gets into the bloodstream, resulting in more stable blood potassium levels.
The research has previously been done in adults and was shown to be effective, but we can’t just borrow evidence from adult research, we need to make sure it’s safe and effective for children through clinical trials.
The trial, which takes place in several countries around the world is sponsored by AstraZeneca and is intended to investigate the safety, efficacy and dosage of the medication in children. As this is a control trial, participants are ‘randomised’ to either receive the new medication, or placebo (inert preparation with no drug effects) but all participants would otherwise receive current standards of care. It is a phase 3 study, meaning the trial is now in a later phase, with large numbers of patients taking part.
The drug is already recommended for use in adults and is available within the NHS. Children who receive it as part of this trial take it orally, by suspending a sachet of granules in water.
Dr Wallace and the RMCH Paediatric Research Team have a recruitment target of one to three patients, with Korbin the first participant at our hospital and in the UK.
Korbin has an immune mediated nephritis, resulting in severe protein leak from the kidneys. As well as some functional impairment, he is on two medications that reduce protein leak and excessive fluid build-up, but the side effect of these is hyperkalaemia (high potassium).
His mum, Simone, said: “A positive of taking part in this trial is this research might help children in future.
The staff at Royal Manchester Children’s Hospital have been absolutely stunning, they were really grateful for us taking part and couldn’t do enough for us.
Dr Wallace echoed these sentiments: “Research can’t happen without the goodwill of families taking part in clinical trials for the future benefit of other children, which is really inspiring.”
Dr Wallace’s path in research
While Dr Wallace has recruited patients to and cared for children taking part in clinical trials previously, this is his first time as a PI.
“The department we have here has a rich research history as Professor Nick Webb, the former Director of the NIHR Manchester Clinical Research Facility, was formerly a nephrologist here. Because of this and the portfolio of research we have here, we are often approached by external organisations and companies wanting to perform clinical trials at RMCH.
“It made sense for me to lead this one as I care for children with advance chronic kidney diseases and it’s been a fascinating experience.”
Nationally, the NIHR is running a campaign to encourage clinical staff to engage with research. Visit the Your Path in Research webpage for more information, including ‘four easy ways to start your research career’.
The full title of this clinical trial is: ‘A Study in Children With Hyperkalaemia Between Birth and <18 Years of Age to Evaluate Doses of Sodium Zirconium Cyclosilicate (SZC) for Correction of Hyperkalaemia and Effectiveness of Same Dose to Maintain Normokalaemia’.
