Renoprotective effects of Ursodeoxycholic acid

• Research type

  Research Study

• Full title

  The renoprotective effects of Ursodeoxycholic acid in patients with type 1 diabetes and macroalbuminuria

• IRAS ID

  147826

• Contact name

  Janaka Karalliedde

• Contact email

  j.karalliedde@kcl.ac.uk

• Sponsor organisation

  King’s College London

• Eudract number

  2015-003609-41

• Duration of Study in the UK

  2 years, 6 months, 0 days

• Research summary

  Kidney disease due to diabetes develops in 30-40% of all patients with diabetes and is the leading cause of end stage renal disease (ESRD). ESRD require dialysis or renal transplantation and has a significant impact on patients, their carers and wider society. A hallmark of kidney disease is the presence of raised amounts of the protein albumin in the urine which is termed albuminuria. Increased levels of albumin in the urine is termed macroalbuminuria and patients with macroalbuminuria are at high risk of ESRD. Drug treatments that are now routinely used and proven to prevent ESRD were first evaluated in patients with type 1 diabetes mellitus (T1DM) and macroalbuminuria. These drugs all demonstrated early reductions in macroalbuminuria which later translated to the prevention/delay of ESRD.
  However despite these drugs patients with T1DM and macroalbuminuria remain at high risk as current treatments cannot allways reduce macroalbuminuria sufficiently/fully with between a third and a half of all patients (32,000 T1DM patients in the UK) at very high risk of ESRD. Our research aims to address this issue by investigating if Ursodeoxycholic acid can reduce albuminuria in patients with T1DM and macroalbuminuria despite established standard care. Ursodeoxycholic acid is a bile acid secreted in humans that helps eliminate cholesterol and dissolve fats. It is currently approved for clinical use and treatment of gall stones and liver disease. In laboratory and animal studies Ursodeoxycholic acid reduces albuminuria and prevent progression of kidney damage.
  If our study indicates that 24 weeks treatment with Ursodeoxycholic acid can reduce albuminuria, this would be of importance as we are in urgent need for new treatments to improve the care of these high risk patients. This work would lead to a larger study with longer follow up to confirm the reduction in albuminuria with Ursodeoxycholic acid prevents/delays ESRD.

  Lay Summary of results
  The aim of our research was to test if Ursodeoxycholic acid (a medication that is currently used as a treatment for gall stones and liver disease) that has shown kidney benefits/protection in animal studies, can reduce albumin levels in the urine (albuminuria) in people with type 1 diabetes and kidney disease.
  The trial was adversely impacted by delays starting the study and the Covid-19 pandemic, however we managed to complete the study as originally planned. In total we studied the 31 people as originally planned.
  This is the first ever human study investigating the potential kidney benefits of Ursodeoxycholic acid in people with diabetes and kidney disease. We observed a small numerical reduction in albumin levels in the urine after 24-weeks treatment with Ursodeoxycholic acid and further larger and longer duration studies are required to clarify the potential long term kidney benefits

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  15/LO/1951

• Date of REC Opinion

  11 Dec 2015

• REC opinion

  Favourable Opinion