End Stage Renal Disease
Conditions
Keywords
peritoneal dialysis, ESRD
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 (1.36%, 2.27% or 3.86% glucose), or Balance, Bicavera, Bicanova or Equibalance (1.5%, 2.3%, 4.25% glucose) - and - one bag of Extraneal (7.5% 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 (7.5% 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 Kt/V of \> 1.7 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.
Interventions
DRUGXyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght
XyloCore Low Strenght: 0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitine - or - XyloCore Medium Strenght: 1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitine - or - XyloCore High Strenght: 2.0% Xylitol, 1.5% Glucose, and 0.02% L-carnitine
DRUG1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD Solution
Physioneal 35 or 40 (including Clear-Flex bag), Fixioneal 35 or 40, Dianeal or Dianeal Low Calcium have 1.36%, 2.27% or 3.86% glucose; Balance, Bicavera, Bicanova or Equibalance have 1.25%, 2.3%, 4.5% glucose.
Sponsors
Iperboreal Pharma Srl
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The study cannot be blinded. The assessment of the primary end-point will be performed by a blinded, third party, independent assessor.
Intervention model description
Randomization will be performed centrally via a web-based system, with stratification according to the presence or absence of diabetes.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years 2. Diagnosed with ESRD and treated with CAPD in the last 3 months 3. In stable clinical condition during the 3 months before screening as demonstrated by the absence of non-elective hospitalization and major cardiovascular events 4. Have not experienced peritonitis episodes in the last 3 months 5. In treatment with prescribed Extraneal (nocturnal exchange bag solution) for at least 1 month 6. In treatment with 1, 2 or 3 diurnal exchange bag solution of prescribed Phisioneal (including Clear-Flex bag), Fixioneal, Dianeal or Dianeal Low Calcium (1.36%, 2.27% or 3.86% glucose), or Balance, Bicavera, Bicanova or Equibalance (1.25%, 2.3%, 4.5% glucose) 7. Kt/V urea measurement \> 1.7 per week at Baseline Visit 8. Followed/treated by the participating clinical Center/Investigator in the last three months 9. Understanding the nature of the study and providing their informed consent to participation.
Exclusion criteria
1. History of drug or alcohol abuse in the six months prior to entering the protocol 2. In treatment with androgens 3. Clinically significant abnormal liver function test (ɣ-GT \> 4 times the upper normal limit) 4. Acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc) 5. Expected patient's survival shorter than the trial duration 6. History of L-Carnitine therapy or use in the month prior to entering the protocol 7. Have used any investigational drug in the 3 months prior to entering the protocol 8. Female patients who are pregnant or breast-feeding. 9. Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception 10. Patients affected by Primary Hyperoxaluria as per known medical therapy 11. Patients with serum levels of uric acid \> 7.2 mg/dl (male and postmenopausal women) or \> 6.0 mg/dl (premenopausal women) 12. Patients with a major cardiovascular event in the last 3 months 13. Patients with advanced cardiac failure (NYHA 4) 14. Hypersensitivity to any of the constituents of the study IMPs. 15. Any contraindication to the prescribed Peritoneal Dialysis solutions (for long-dwell and short-dwell exchange) as per each product SmPC. 16. Participants with medical history of oxalate or lactate abnormalities considered clinically significant by the investigator. 17. History or evidence of any other medical, neurological or psychological condition that would expose the subject to an undue risk of a significant AE or interfere with study assessments during the course of the trial as determined by the clinical judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total weekly Kt/Vurea | 24-week | To measure solutes and calculate peritoneal and renal Kt/V (summing up to total Kt/V), dialysate outflow and urine covering 24 hours will be collected, the volumes will be determined, and a blood sample will be taken |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in HbA1c (glycated haemoglobin) | 6 months | Change from baseline value |
| Insulin | 6 months | Changes from the baseline value |
| LDL cholesterol | 6 months | Changes from the baseline value |
| HDL cholesterol | 6 months | Change from the baseline value |
| Serum triglycerides | 6 months | Change from the baseline value |
| Total cholesterol | 6 months | Changes from the baseline |
| Hemoglobin | 6 months | Changes from the baseline value |
| EPO requirements | 6 months | Change from the baseline |
| Fatigue measured through a validated instrument | 6 months | Changes from the baseline |
| Peritoneal ultrafiltration | 6 months | Changes from baseline |
| Diuresis (or 24 hours urinary volume) | 6 months | Changes from baseline |
| Residual renal function | 6 months | Changes from baseline - measured as the arithmetic mean of urinary urea and creatinine clearance |
| Adverse Events | 6 months | Information about all adverse events, whether volunteered by the patient, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded and followed as appropriate. |
Countries
Denmark, Germany, Italy, Spain, Sweden, United Kingdom
Contacts
CONTACTArduino Arduini, MD
STUDY_DIRECTORArduino Arduini, MD
Iperboreal Pharma
STUDY_CHAIRWerner Kleophas, MD
DaVita Deutschland AG
Outcome results
None listed