Evaluate the Efficacy and Safety of XyloCore for Peritoneal Dialysis

• Research type

  Research Study

• Full title

  A Study to EvaLuate the EffIcacy and Safety of XyloCore, a Glucose SparIng ExpeRimental Solution, for Peritoneal Dialysis

• IRAS ID

  1005365

• Contact name

  Adriano Arduini

• Contact email

  a.arduini@iperboreal.com

• Sponsor organisation

  Iperboreal Pharma

• Eudract number

  2019-004183-21

• ISRCTN Number

  ISRCTN16169961

• Clinicaltrials.gov Identifier

  NCT03994471

• Research summary

  XyloCore is a new solution for peritoneal dialysis. Current commercial peritoneal dialysis solutions have a high glucose content that could alter the function of the peritoneum (abdomen cavity) and increase glycemia (glucose blood level) when administered for a long time. Xylocore solutions substitute a part of this glucose with other agents (xylitol and carnitine) to preserve patient functionality of peritoneum and glycemia in the long term, while achieving a similar depuration efficacy compared to current commercial solutions. Preliminary results of a clinical study (phase 2) on XyloCore showed an improved depuration and fluids removal without relevant undesirable effects. Based on the promising results from phase 2, the current study was designed to investigate if XyloCore has similar efficacy to the commercial products containing glucose.
  Patients will have peritoneal dialysis for 6 months which will be done by the patient at home. They will have 6 monthly clinic visits for safety and efficacy review.
  The following assessments will be performed as part of the study:
  1. Collection of demographic information and medical history
  2. Some patients will have pregnancy testing
  3. Vital signs (temperature, blood pressure)
  4. Physical exam
  5. Genetic testing for Primary Hyperoxaluria - patients who are at risk of hyperoxaluria will be excluded
  6. Weekly Kt/V - it is a parameter to assess how good the dialysis is for the patient
  7. Glycemic and Lipid Metabolic Parameters
  8. Peritoneal Ultrafiltration (24 hrs) and Diuresis (24 hrs)
  9. Residual kidney function
  10. EPO requirement - medication to prevent anemia
  11. Blood tests - chemistry and haematology
  12. Oxalate levels
  13. Fatigue questionnaire
  14. Patient diary
  15. Collection of Specimens for Future Studies - applicable only for patients who have consented

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  22/EE/0102

• Date of REC Opinion

  1 Jul 2022

• REC opinion

  Further Information Favourable Opinion