| 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 |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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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
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Arduino Arduini, MD | +39.333.6409595 | a.arduini@iperboreal.com |
| 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 | |
| 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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