Paracetamol in treatment of cystinuria

• Research type

  Research Study

• Full title

  An exploratory, randomised, 3-way crossover study to determine the effect of paracetamol on urinary cystine excretion in cystinuria

• IRAS ID

  67161

• Sponsor organisation

  Royal Liverpool and Broadgreen University Hospitals NHS Trust

• Eudract number

  2011-002466-20

• Research summary

  Cystinuria is a hereditary condition where the kidney fails to reabsorb cystine (a building block of protein) back into the body. Consequently, patients with cystinuria have high urine cystine concentration and are prone to form cystine stones in their urinary tract. Recurrent stone formation is the only clinical presentation in cystinuric patients and the current mainstay treatment is prevention of stone. At present, there is a lack of effective pharmacological agent with little side effects for cystinuria. We speculate that part of the in vivo metabolism of paracetamol may help to reduce the bioavailability of cystine. The objective of this study is to determine the effect of paracetamol in urinary cystine excretion in cystinuria. We aim to recruit 18 cystinuric patients who are followed up in our metabolic stone clinic at the Royal Liverpool and Broadgreen hospitals. We may write to other consultant urologist colleagues within Merseyside to invite more cystinuric patients if necessary. This is an exploratory, randomised 3-way crossover study. The crossover will be between patients taking paracetamol 4g/day, paracetamol 2g/day and no paracetamol (control group). All patients will be in each group for 1 week with a washout period of 1 week in between. Patients are expected to be involved for a total duration of 6 weeks. A baseline 24-urine cystine level and blood test for liver function will be carried out before the start of study. Patients will be required to provide two 24-hour urine samples and two blood samples for each of the week they are on treatment or control group. All patients are requested to report any adverse events during the study.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  11/NW/0571

• Date of REC Opinion

  29 Sep 2011

• REC opinion

  Further Information Favourable Opinion