A Study to EvaLuate the EffIcacy and Safety of XyloCore, a Glucose SparIng ExpeRimental Solution, for Peritoneal Dialysis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 41
- 主要终点
- Total weekly Kt/Vurea
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study cannot be blinded. The assessment of the primary end-point will be performed by a blinded, third party, independent assessor.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Diagnosed with ESRD and treated with CAPD in the last 3 months
- •In stable clinical condition during the 3 months before screening as demonstrated by the absence of non-elective hospitalization and major cardiovascular events
- •Have not experienced peritonitis episodes in the last 3 months
- •In treatment with prescribed Extraneal (nocturnal exchange bag solution) for at least 1 month
- •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)
- •Kt/V urea measurement > 1.7 per week at Baseline Visit
- •Followed/treated by the participating clinical Center/Investigator in the last three months
- •Understanding the nature of the study and providing their informed consent to participation.
排除标准
- •History of drug or alcohol abuse in the six months prior to entering the protocol
- •In treatment with androgens
- •Clinically significant abnormal liver function test (ɣ-GT > 4 times the upper normal limit)
- •Acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc)
- •Expected patient's survival shorter than the trial duration
- •History of L-Carnitine therapy or use in the month prior to entering the protocol
- •Have used any investigational drug in the 3 months prior to entering the protocol
- •Female patients who are pregnant or breast-feeding.
- •Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception
- •Patients affected by Primary Hyperoxaluria as per known medical therapy
- •Patients with serum levels of uric acid > 7.2 mg/dl (male and postmenopausal women) or > 6.0 mg/dl (premenopausal women)
- •Patients with a major cardiovascular event in the last 3 months
- •Patients with advanced cardiac failure (NYHA 4)
- •Hypersensitivity to any of the constituents of the study IMPs.
- •Any contraindication to the prescribed Peritoneal Dialysis solutions (for long-dwell and short-dwell exchange) as per each product SmPC.
- •Participants with medical history of oxalate or lactate abnormalities considered clinically significant by the investigator.
- •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.
研究组 & 干预措施
XyloCore peritoneal dialysis solution
Patients will receive 1, 2 or 3 daily (short-dwell) exchanges with XyloCore of an osmotic strength comparable to their pre-randomization prescription of glucose peritoneal dialysis solution (XyloCore Low, Medium and High Strenght have an osmotic strength comparable to Physioneal, Fixioneal or Dianeal 1.36%, 2.27%, 3.86% glucose, respectively, and Balance, Bicavera, Bicanova or Equibalance with 1.5%, 2.5%, 4.25% glucose, respectively). All patients will receive Extraneal (7.5% Icodextrin) for nocturnal (long-dwell) exchange.
干预措施: XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght (Drug)
Glucose peritoneal dialysis solution
Patients randomized to glucose solution will continue the 1, 2 or 3 daily (short-dwell) exchanges of Physioneal 40 or 35, Fixioneal 40 or 35 or Dianeal (1.36%, 2.27%, 3.86% glucose), Balance, Bicavera, Bicanova or Equibalance (1.5%, 2.5%, 4.25% glucose) with the same osmotic strength of their pre-randomization prescription. All patients will receive Extraneal (7.5% Icodextrin) for nocturnal (long-dwell) exchange.
干预措施: 1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD Solution (Drug)
结局指标
主要结局
Total weekly Kt/Vurea
时间窗: 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
次要结局
- Serum triglycerides(6 months)
- Changes in HbA1c (glycated haemoglobin)(6 months)
- Insulin(6 months)
- LDL cholesterol(6 months)
- HDL cholesterol(6 months)
- Total cholesterol(6 months)
- Hemoglobin(6 months)
- EPO requirements(6 months)
- Fatigue measured through a validated instrument(6 months)
- Peritoneal ultrafiltration(6 months)
- Diuresis (or 24 hours urinary volume)(6 months)
- Residual renal function(6 months)
- Adverse Events(6 months)