Ignite Creation Date:
2024-05-06 @ 1:19 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03994471
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2019-06-19
Brief Title:
Efficacy and Safety of XyloCore Peritoneal Dialysis Solution
Sponsor:
Iperboreal Pharma Srl
Organization:
Iperboreal Pharma Srl
Study Overview
Official Title:
A Study to EvaLuate the EffIcacy and Safety of XyloCore a Glucose SparIng ExpeRimental Solution for Peritoneal Dialysis
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELIXIR
Brief Summary:
Randomized controlled parallel groups open-label blinded end-point assessment multicenter study comparing the effects of a low glucose peritoneal dialysis solution XyloCore to glucose solutions Physioneal Fixioneal Dianeal Balance Bicavera Bicanova or Equibalance only regimen in patients with End-Stage Renal Disease ESRD receiving Continuous Ambulatory Peritoneal Dialysis CAPD over a 6-month study period
Detailed Description:
Patients should be enrolled if they are receiving 1 2 or 3 diurnal exchanges of one of the following PD solutions standard treatment Physioneal 35 or 40 including Clear-Flex bag Fixioneal 35 or 40 Dianeal or Dianeal Low Calcium 136 227 or 386 glucose or Balance Bicavera Bicanova or Equibalance 15 23 425 glucose - and - one bag of Extraneal 75 Icodextrin for the long-dwell exchange Patients will be centrally randomized to the investigational product XyloCore or the glucose-only PD solution active comparator Patients randomized to the control group will continue with their prescription of standard treatment with 1 2 to 3 daily short-dwell exchanges of Physioneal Fixioneal Dianeal Balance Bicavera Bicanova or Equibalance PD solution Patients randomized to XyloCore will receive XyloCore Low Medium or High Strength according to the osmotic strength glucose concentration of their prerandomization prescribed PD solution All patients will keep being prescribed Extraneal 75 Icodextrin for the nocturnal long-dwell exchange The osmotic strength and number of diurnal short dwell exchanges may be modified by the investigator as clinically required PD prescriptions in both treatment arms should be tailored to reach the minimum target of a total KtV of 17 per week throughout the study A stratified randomization scheme will be employed to ensure balanced allocation across the two treatment groups of patients with diabetes and of patients treated with only 1 diurnal exchange Randomization will be performed centrally via a web-based system according to a computer-generated randomization list The study is open-label with blinded evaluator primary endpoint without blinding of patients or clinical staff
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-004183-21 | EUDRACT_NUMBER | None | None |