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出境医 / 临床实验 / Efficacy and Safety of XyloCore Peritoneal Dialysis Solution. (Elixir)
Efficacy and Safety of XyloCore Peritoneal Dialysis Solution. (Elixir)
Study Description
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| End Stage Renal Disease | Drug: XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght Drug: 1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD Solution | Phase 3 |
Detailed Description:
Patients should be enrolled if they are receiving 2 or 3 diurnal (short dwell) exchange bag solution of 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 (1.25%, 2.3%, 4.5% glucose) and Extraneal (7.5% Icodextrin) for the long-dwell exchange. Patients will be centrally randomized to receive the investigational product (XyloCore) or the active control (Physioneal, Fixioneal, Dianeal, Balance, Bicavera, Bicanova or Equibalance). A stratified randomization scheme will be employed to ensure a balanced allocation of patients with diabetes across the two treatment groups. Patients randomized to XyloCore will receive 2 to 3 bags of XyloCore (Low, Medium or High Strenght) with an osmotic strength comparable to their pre-randomization prescription of the glucose peritoneal dialysis solution. Patients randomized to the control group will continue the 2 to 3 daily (short-dwell) exchanges of Physioneal, Fixioneal, Dianeal, Balance, Bicavera, Bicanova or Equibalance. All patients will receive Extraneal (7.5% Icodextrin) for nocturnal (long-dwell) exchange. The osmotic strength and number of diurnally short dwells exchanges should be modified by the investigator as clinically required. PD prescriptions in both treatment arms are tailored to reach a minimum target of total Kt/V of 1.7 per week throughout the study. The study will be single-blinded (outcomes assessor), without blinding of patients or clinical staff.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 170 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Randomization will be performed centrally via a web-based system, with stratification according to the presence or absence of diabetes. |
| 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. |
| Primary Purpose: | Treatment |
| Official Title: | A Study to EvaLuate the EffIcacy and Safety of XyloCore, a Glucose SparIng ExpeRimental Solution, for Peritoneal Dialysis |
| Estimated Study Start Date : | April 2021 |
| Estimated Primary Completion Date : | May 2022 |
| Estimated Study Completion Date : | August 2022 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: XyloCore peritoneal dialysis solution
Patients will receive 2 to 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.
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Drug: XyloCore 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
Other Name: XyloCore 0.7 or 1.5 or 2.0
|
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Active Comparator: Glucose peritoneal dialysis solution
Patients randomized to glucose solution will continue the 2 to 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.
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Drug: 1.36%, 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.
Other Name: Physioneal 40 or 35, Fixioneal 40 or 35, Dianeal, Balance, Bicavera, Bicanova, Equibalance
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Outcome Measures
Primary Outcome Measures :
- Total weekly Kt/Vurea [ Time Frame: 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 Outcome Measures :
- Changes in HbA1c (glycated haemoglobin) [ Time Frame: 6 months ]Change from baseline value
- Insulin [ Time Frame: 6 months ]Changes from the baseline value
- LDL cholesterol [ Time Frame: 6 months ]Changes from the baseline value
- HDL cholesterol [ Time Frame: 6 months ]Change from the baseline value
- Serum triglycerides [ Time Frame: 6 months ]Change from the baseline value
- Total cholesterol [ Time Frame: 6 months ]Changes from the baseline
- Hemoglobin [ Time Frame: 6 months ]Changes from the baseline value
- EPO requirements [ Time Frame: 6 months ]Change from the baseline
- Fatigue measured through a validated instrument [ Time Frame: 6 months ]Changes from the baseline
- Peritoneal ultrafiltration [ Time Frame: 6 months ]Changes from baseline
- Diuresis (or 24 hours urinary volume) [ Time Frame: 6 months ]Changes from baseline
- Residual renal function [ Time Frame: 6 months ]Changes from baseline - measured as the arithmetic mean of urinary urea and creatinine clearance
- Adverse Events [ Time Frame: 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.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age ≥18 years
- Diagnosed with ESRD and treated with CAPD in the last 3 months
- In a 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 2 to 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.
Exclusion Criteria:
- 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, including carrier heterozygous
- 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)
- Patients with advanced COPD, characterized by GOLD Guidelines class 3, severe (FEV1/FVC ˂ 0.70; 30% ≤ FEV1 ˂50% predicted) and class 4, very severe (FEV1/FVC ˂ 0.70; FEV1 ˂30% predicted or FEV1 ˂ 50% predicted plus chronic respiratory failure)
Contacts and Locations
Contacts
| Contact: Arduino Arduini, MD | +39.333.6409595 | a.arduini@iperboreal.com |
Locations
| Germany | |
| MVZ DaVita Rhein-Ruhr GmbH | |
| Düsseldorf, Germany, D-40210 | |
| Contact: Werner Kleophas, MD werner.kleophas@davita-dialyse.de | |
| Italy | |
| Department of Nephrology, University of Chieti | |
| Chieti, Italy | |
| Contact: Mario Bonomini, MD mario.bonomini@unich.it | |
Sponsors and Collaborators
Iperboreal Pharma Srl
Investigators
| Study Director: | Arduino Arduini, MD | Iperboreal Pharma | |
| Study Chair: | Werner Kleophas, MD | DaVita Deutschland AG |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 19, 2019 | ||||||
| First Posted Date ICMJE | June 21, 2019 | ||||||
| Last Update Posted Date | February 10, 2021 | ||||||
| Estimated Study Start Date ICMJE | April 2021 | ||||||
| Estimated Primary Completion Date | May 2022 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
Total weekly Kt/Vurea [ Time Frame: 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
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Efficacy and Safety of XyloCore Peritoneal Dialysis Solution. | ||||||
| Official Title ICMJE | A Study to EvaLuate the EffIcacy and Safety of XyloCore, a Glucose SparIng ExpeRimental Solution, for Peritoneal Dialysis | ||||||
| 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 2 or 3 diurnal (short dwell) exchange bag solution of 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 (1.25%, 2.3%, 4.5% glucose) and Extraneal (7.5% Icodextrin) for the long-dwell exchange. Patients will be centrally randomized to receive the investigational product (XyloCore) or the active control (Physioneal, Fixioneal, Dianeal, Balance, Bicavera, Bicanova or Equibalance). A stratified randomization scheme will be employed to ensure a balanced allocation of patients with diabetes across the two treatment groups. Patients randomized to XyloCore will receive 2 to 3 bags of XyloCore (Low, Medium or High Strenght) with an osmotic strength comparable to their pre-randomization prescription of the glucose peritoneal dialysis solution. Patients randomized to the control group will continue the 2 to 3 daily (short-dwell) exchanges of Physioneal, Fixioneal, Dianeal, Balance, Bicavera, Bicanova or Equibalance. All patients will receive Extraneal (7.5% Icodextrin) for nocturnal (long-dwell) exchange. The osmotic strength and number of diurnally short dwells exchanges should be modified by the investigator as clinically required. PD prescriptions in both treatment arms are tailored to reach a minimum target of total Kt/V of 1.7 per week throughout the study. The study will be single-blinded (outcomes assessor), without blinding of patients or clinical staff. | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 3 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Randomization will be performed centrally via a web-based system, with stratification according to the presence or absence of diabetes. 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. Primary Purpose: Treatment
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| Condition ICMJE | End Stage Renal Disease | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||
| Estimated Enrollment ICMJE |
170 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | August 2022 | ||||||
| Estimated Primary Completion Date | May 2022 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Germany, Italy | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03994471 | ||||||
| Other Study ID Numbers ICMJE | IP-001-18 2019-004183-21 ( EudraCT Number ) |
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| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||
| Responsible Party | Iperboreal Pharma Srl | ||||||
| Study Sponsor ICMJE | Iperboreal Pharma Srl | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Iperboreal Pharma Srl | ||||||
| Verification Date | February 2021 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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