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Efficacy and Safety of XyloCore Peritoneal Dialysis Solution. (ELIXIR)

Primary Purpose

End Stage Renal Disease

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght
1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD Solution
Sponsored by
Iperboreal Pharma Srl
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring peritoneal dialysis, ESRD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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)

Sites / Locations

  • Aarhus University Hospital
  • Herlev og Gentofte Hospital
  • Kolding Medicinske Sygedomme
  • Zealand University Hospital
  • Dialysis Center DaVita
  • Ospedale Madonna del SoccorsoRecruiting
  • Azienda Universitaria Ospedaliera di Bari
  • Ospedale SS. AnnunziataRecruiting
  • Ospedale Leopoldo Parodi Delfino
  • A.O.U. Ospedali Riuniti di FoggiaRecruiting
  • ASST Fatebenefratelli-Sacco -Ospedale Luigi Sacco
  • Azienda Ospedaliera Universitaria di Modena
  • AOU Università degli studi della Campania
  • Università della Campania L.Vanvitelli
  • Ospedale AUSL "Guglielmo da Saliceto"
  • Ospedale S.Eugenio
  • Policlinico Gemelli
  • Policlinico Umberto I
  • Ospedale C. e G. MazzoniRecruiting
  • Azienda Ospedaliera Terni
  • Azienda Ospedaliera Universitaria Integrata di Verona
  • Ospedale San Bortolo
  • University Hospital A Coruña Fundación Profesor Novoa Santos
  • Hospital U. Germans Trias i Pujol
  • Fundaciòn Puigvert
  • Hospital Universitario Josep Trueta
  • Fundacion Jimenez Diaz
  • Hospital Doce de Octubre
  • Hospital Ramón y Cajal
  • Hospital Universitario La Paz
  • Hospital Universitario Central De AsturiasRecruiting
  • Halland County Hospital of HalmstadRecruiting
  • Karolinska University Hospital
  • Heartlands Hospital
  • St Luke's HospitalRecruiting
  • Kent and Canterbury Hospital
  • Hammersmith HospitalRecruiting
  • Churchill Hospital
  • Royal Berkshire Hospital
  • Sheffield Kidney Institute
  • University Hospitals of North Midlands

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

XyloCore peritoneal dialysis solution

Glucose peritoneal dialysis solution

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Total weekly Kt/Vurea
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)
Change from baseline value
Insulin
Changes from the baseline value
LDL cholesterol
Changes from the baseline value
HDL cholesterol
Change from the baseline value
Serum triglycerides
Change from the baseline value
Total cholesterol
Changes from the baseline
Hemoglobin
Changes from the baseline value
EPO requirements
Change from the baseline
Fatigue measured through a validated instrument
Changes from the baseline
Peritoneal ultrafiltration
Changes from baseline
Diuresis (or 24 hours urinary volume)
Changes from baseline
Residual renal function
Changes from baseline - measured as the arithmetic mean of urinary urea and creatinine clearance
Adverse Events
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.

Full Information

First Posted
June 19, 2019
Last Updated
May 19, 2023
Sponsor
Iperboreal Pharma Srl
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1. Study Identification

Unique Protocol Identification Number
NCT03994471
Brief Title
Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.
Acronym
ELIXIR
Official Title
A Study to EvaLuate the EffIcacy and Safety of XyloCore, a Glucose SparIng ExpeRimental Solution, for Peritoneal Dialysis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iperboreal Pharma Srl

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
peritoneal dialysis, ESRD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomization will be performed centrally via a web-based system, with stratification according to the presence or absence of diabetes.
Masking
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.
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
XyloCore peritoneal dialysis solution
Arm Type
Experimental
Arm Description
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.
Arm Title
Glucose peritoneal dialysis solution
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght
Other Intervention Name(s)
XyloCore 0.7 or 1.5 or 2.0
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD Solution
Other Intervention Name(s)
Physioneal 40 or 35, Fixioneal 40 or 35, Dianeal, Balance, Bicavera, Bicanova, Equibalance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total weekly Kt/Vurea
Description
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
Time Frame
24-week
Secondary Outcome Measure Information:
Title
Changes in HbA1c (glycated haemoglobin)
Description
Change from baseline value
Time Frame
6 months
Title
Insulin
Description
Changes from the baseline value
Time Frame
6 months
Title
LDL cholesterol
Description
Changes from the baseline value
Time Frame
6 months
Title
HDL cholesterol
Description
Change from the baseline value
Time Frame
6 months
Title
Serum triglycerides
Description
Change from the baseline value
Time Frame
6 months
Title
Total cholesterol
Description
Changes from the baseline
Time Frame
6 months
Title
Hemoglobin
Description
Changes from the baseline value
Time Frame
6 months
Title
EPO requirements
Description
Change from the baseline
Time Frame
6 months
Title
Fatigue measured through a validated instrument
Description
Changes from the baseline
Time Frame
6 months
Title
Peritoneal ultrafiltration
Description
Changes from baseline
Time Frame
6 months
Title
Diuresis (or 24 hours urinary volume)
Description
Changes from baseline
Time Frame
6 months
Title
Residual renal function
Description
Changes from baseline - measured as the arithmetic mean of urinary urea and creatinine clearance
Time Frame
6 months
Title
Adverse Events
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: 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 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arduino Arduini, MD
Phone
+39.333.6409595
Email
a.arduini@iperboreal.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arduino Arduini, MD
Organizational Affiliation
Iperboreal Pharma
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Werner Kleophas, MD
Organizational Affiliation
DaVita Deutschland AG
Official's Role
Study Chair
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johan Povlsen, MD
Facility Name
Herlev og Gentofte Hospital
City
Herlev
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rizwan Ahmed Butt, MD
Facility Name
Kolding Medicinske Sygedomme
City
Kolding
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Kjaergaard, MD
Facility Name
Zealand University Hospital
City
Roskilde
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirstine Møller Gliese, MD
Facility Name
Dialysis Center DaVita
City
Düsseldorf
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thilo Krueger, MD
Facility Name
Ospedale Madonna del Soccorso
City
Ascoli Piceno
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Zeiler, MD
Facility Name
Azienda Universitaria Ospedaliera di Bari
City
Bari
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loreto Gesualdo, MD
Facility Name
Ospedale SS. Annunziata
City
Chieti
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Bonomini, MD
Email
mario.bonomini@unich.it
Facility Name
Ospedale Leopoldo Parodi Delfino
City
Colleferro
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Di Lullo, MD
Facility Name
A.O.U. Ospedali Riuniti di Foggia
City
Foggia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Stallonee, MD
Facility Name
ASST Fatebenefratelli-Sacco -Ospedale Luigi Sacco
City
Milano
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maurizio Gallieni, MD
Facility Name
Azienda Ospedaliera Universitaria di Modena
City
Modena
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriele Donati, MD
Facility Name
AOU Università degli studi della Campania
City
Napoli
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Trepiccione, MD
Facility Name
Università della Campania L.Vanvitelli
City
Napoli
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvio Borrelli, MD
Facility Name
Ospedale AUSL "Guglielmo da Saliceto"
City
Piacenza
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Scarpioni, MD
Facility Name
Ospedale S.Eugenio
City
Roma
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Palumbo, MD
Facility Name
Policlinico Gemelli
City
Roma
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Grandaliano, MD
Facility Name
Policlinico Umberto I
City
Roma
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandro Mazzaferro, MD
Facility Name
Ospedale C. e G. Mazzoni
City
San Benedetto Del Tronto
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Zailer, MD
Facility Name
Azienda Ospedaliera Terni
City
Terni
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luigi Vecchi, MD
Facility Name
Azienda Ospedaliera Universitaria Integrata di Verona
City
Verona
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Gambaro, MD
Facility Name
Ospedale San Bortolo
City
Vicenza
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Zanella, MD
Facility Name
University Hospital A Coruña Fundación Profesor Novoa Santos
City
A Coruña
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Perez Fontan, MD
Facility Name
Hospital U. Germans Trias i Pujol
City
Badalona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Troya Saborido, MD
Facility Name
Fundaciòn Puigvert
City
Barcelona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Alba Herreros, MD
Facility Name
Hospital Universitario Josep Trueta
City
Girona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Castillo Devia
Facility Name
Fundacion Jimenez Diaz
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catalina Cleary, MD
Facility Name
Hospital Doce de Octubre
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula Caro Espada, MD
Facility Name
Hospital Ramón y Cajal
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haridian Sosa Barrios, MD
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Bajo, MD
Facility Name
Hospital Universitario Central De Asturias
City
Oviedo
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Rodriguez Suarez, MD
Facility Name
Halland County Hospital of Halmstad
City
Halmstad
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karl Bjurström, MD
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olof Heimbürger, MD
Facility Name
Heartlands Hospital
City
Birmingham
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jyoti Baharani, MD
Facility Name
St Luke's Hospital
City
Bradford
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahsan Syed, MD
Facility Name
Kent and Canterbury Hospital
City
Canterbury
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nilesh Kumar Shah, MD
Facility Name
Hammersmith Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Corbett, MD
Facility Name
Churchill Hospital
City
Oxford
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Udaya Udayaraj, MD
Facility Name
Royal Berkshire Hospital
City
Reading
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Flossmann, MD
Facility Name
Sheffield Kidney Institute
City
Sheffield
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Wilkie, MD
Facility Name
University Hospitals of North Midlands
City
Stoke-on-Trent
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Lambie, MD

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.

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