The Genetics of 5ASA Induced Nephrotoxicity

Help is required to identify patients for this study investigating the genetics of 5ASA induced nephrotoxicity. This is the first of what we hope will be a series of genetic studies, led by the UK IBD Genetics consortium, investigating rare adverse drug events. The study had been adopted as an NIHR portfolio study (renal & gastro) and is funded by the Serious Adverse Events Forum.

Our aim is to recruit 200 UK patients and a further 100 international patients over the next 2 years. Although this is a very rare side effect the Drug Induced Liver Injury group have demonstrated that it can be done! Using the NIHR infrastructure we need to establish as many research sites across the UK as possible to facilitate case identification and recruitment. Most of the paperwork relating to site set up can be done from our research office.

We anticipate that each UK hospital might be looking after 2-3 patients who meet the inclusion criteria. These might include patients previously submitted to the 2001/2 BSG postal survey, as well as any patients who have developed this complication more recently.

The phenotype is defined by a series of major and minor criteria which allow us to rank how certain we are that the 5ASA is responsible. Any patient that meets the major criteria might be eligible:

  • Patients aged 16 years or over
  • Normal Creatinine or eGFR at baseline
  • ≥ 50% rise in serum creatinine (with corresponding fall in eGFR), any time after introduction of 5-ASA
  • Medical opinion implicating 5-ASA justifies drug withdrawal, even if temporary.

For each patient a CRF and patient questionnaire needs to be completed and a blood sample taken. We can assist with the completion of the CRF.

For more information, please visit, which will have all the information including the protocol and CRF. If would like to get involved or would like any further information then please do not hesitate to contact me. To get the ball rolling I need details of your nurse (if you have one!) and a contact in your R&D Dept. You will also need an IRAS log in and password.

Dr Tariq Ahmad
Royal Devon & Exeter Hospital

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