Clinical trial • Phase III • Nephrology

Levocarnitine; Glucose monohydrate; Xylitol for End-stage renal disease

Phase III trial of Levocarnitine; Glucose monohydrate; Xylitol for End-stage renal disease.

Overview

Trial Therapeutic Area
Nephrology
Trial Disease
End-stage renal disease
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
30-05-2024
First CTIS Authorization Date
03-07-2024

Trial design

Randomised, open-label, glucose-based peritoneal dialysis solutions (control arm). examples of comparator products listed: physioneal, fixioneal, dianeal (and dianeal low calcium), balance / bicavera / bicanova / equibalance (various glucose concentrations). route: intraperitoneal; dose/schedule as per standard pd prescription (not specified in protocol). Phase III trial in Sweden, Germany, Denmark and others.

Randomised
Yes
Open Label
Yes
Comparator
Glucose-based peritoneal dialysis solutions (control arm). Examples of comparator products listed: Physioneal, Fixioneal, Dianeal (and Dianeal Low Calcium), Balance / bicaVera / Bicanova / EquiBalance (various glucose concentrations). Route: intraperitoneal; dose/schedule as per standard PD prescription (not specified in protocol).
Target Sample Size
160
Trial Duration For Participant
180

Eligibility

Recruits 160 Vulnerable population selected. Participants are adults (Age ≥18) with end-stage kidney disease; informed consent must be provided by the participant. Country-specific subject information sheets and informed consent forms are provided (versions available for Sweden, Germany, Denmark, Italy, Spain). Separate consent documents for genetic testing/personal data are available where applicable..

Pregnancy Exclusion
Female patients who are pregnant or breast-feeding
Vulnerable Population
Vulnerable population selected. Participants are adults (Age ≥18) with end-stage kidney disease; informed consent must be provided by the participant. Country-specific subject information sheets and informed consent forms are provided (versions available for Sweden, Germany, Denmark, Italy, Spain). Separate consent documents for genetic testing/personal data are available where applicable.

Inclusion criteria

  • {"criterion_text":"- Age ≥18 years\n- Diagnosis of ESRD and treated with CAPD in the last 3 months\n- In stable clinical condition during the 3 months before screening as demonstrated by the absence of non-elective hospitalisation and major cardiovascular events\n- Have not experienced peritonitis episodes in the last 3 months\n- In treatment with Extraneal (nocturnal long-dwell exchange for at least one month)\n- In treatment with 1, 2 or 3 short-dwell prescribed exchanges with Physioneal (including Clear-Flex bag), Fixioneal, Dianeal or Dianeal Low Calcium (1.36%, 2.27% or 3.86% glucose), or Balance, Bicavera, Bicanova or Equibalance (1.5%, 2.3%, 4.25% glucose)\n- Weekly Kt/V urea measurement > 1.7\n- Followed-up/treated by the participating clinical Center/Investigator in the last three months\n- Understanding the nature of the study and providing informed consent to participate in the study"}

Exclusion criteria

  • {"criterion_text":"- History of drug or alcohol abuse in the six months prior to entering the protocol\n- Patients with medical history of oxalate or lactate abnormalities considered clinically significant by the investigator\n- Patients who have used any investigational drug in the 3 months prior to entering the protocol\n- In treatment with androgens\n- Clinically significant abnormal liver function test (Gamma-GT and/or AST and/or ALT > 2 UNL; and/or total bilirubin > 3 UNL)\n- Acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low tract urinary infections, renal parenchymal infection, pericarditis, etc)\n- Expected patient’s survival shorter than trial duration\n- L-Carnitine therapy in the month prior to entering the protocol\n- Have used any investigational drug in the 3 months prior to entering the protocol\n- Patients affected by Primary Hyperoxaluria as per known medical history\n- Patients affected by gout, who have had one or more flares of gout during the last 12 months before the screening, with serum levels of uric acid > 7.2 mg/dl (male and postmenopausal women) or > 6.0 mg/dl (premenopausal women)\n- Patients with a major cardiovascular event in the last 3 months\n- Patients with advanced cardiac failure (NYHA 4)\n- Hypersensitivity to any of the constituents of the study IMPs\n- Any contraindication to the prescribed Peritoneal Dialysis solutions (for long-dwell and short-dwell exchange) as per each product SmPC\n- Participants with medical history of oxalate or lactate abnormalities considered clinically significant by the investigator\n- 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"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Weekly Kt/V urea (V1, V3, V4, V5)","definition_or_measurement_approach":"Weekly Kt/V urea measured at visits V1, V3, V4 and V5"}

Secondary endpoints

  • {"endpoint_text":"- Glycemic and lipid metabolic parameters: LDL, HDL and total cholesterol, serum triglycerides, insulin (V1, V3, V4, V5)","definition_or_measurement_approach":"Measured biochemical parameters at visits V1, V3, V4, V5"}
  • {"endpoint_text":"- EPO requirements (V1, V3, V5)","definition_or_measurement_approach":"EPO usage recorded at visits V1, V3 and V5"}
  • {"endpoint_text":"- Patients’ subjective assessment of fatigue (V1, V3, V5)","definition_or_measurement_approach":"Patient-reported fatigue assessed (Chalder Fatigue Scale) at visits V1, V3 and V5"}
  • {"endpoint_text":"- 24h peritoneal dialysate analysis: volume, ultrafiltration, urea, creatinine (V1, V3, V4, V5)","definition_or_measurement_approach":"24-hour peritoneal dialysate measurements at visits V1, V3, V4, V5"}
  • {"endpoint_text":"- 24h urine analysis: volume, urea, creatinine (V1, V3, V4, V5)","definition_or_measurement_approach":"24-hour urine collections analysed at visits V1, V3, V4, V5"}
  • {"endpoint_text":"- Residual Kidney Function (V1, V3, V4, V5)","definition_or_measurement_approach":"Residual kidney function assessed at visits V1, V3, V4, V5 (e.g., via urine clearances/24h collections as per protocol)"}
  • {"endpoint_text":"- Safety, evaluated by physical examinations, vital signs, laboratory outcomes and adverse events (whole study)","definition_or_measurement_approach":"Safety assessed throughout study by physical exams, vitals, labs and recording of adverse events"}

Recruitment

Planned Sample Size
160
Recruitment Window Months
33
Consent Approach
Informed consent is required from each participant (participants must understand the study and provide written informed consent). Only adults (≥18) are eligible. Country-specific subject information sheets and ICFs are provided (documents available in Swedish, German, Danish, Italian and Spanish). Separate consent forms/materials are provided for genetic testing and personal data where applicable.

Geography

Total Number Of Sites
38
Total Number Of Participants
160

Sweden

Earliest CTIS Part Ii Submission Date
17-06-2024
Latest Decision Or Authorization Date
13-03-2025
Processing Time Days
269
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Region Halland
Department Name
Nephrology
Contact Person Name
Karl Bjurström
Site Name
Karolinska University Hospital
Department Name
Njurmedicin
Contact Person Name
Olof Heimburger
Contact Person Email
olof.heimburger@ki.se

Germany

Earliest CTIS Part Ii Submission Date
17-06-2024
Latest Decision Or Authorization Date
14-03-2025
Processing Time Days
270
Number Of Sites
1
Number Of Participants
15

Sites

Site Name
DaVita Clinical Research Deutschland GmbH
Department Name
Nephrology
Contact Person Name
Thilo Krueger
Contact Person Email
thilo.krueger@davita.com

Denmark

Earliest CTIS Part Ii Submission Date
17-06-2024
Latest Decision Or Authorization Date
19-05-2025
Processing Time Days
336
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
Region Sjaelland
Department Name
Nephrology
Contact Person Name
Kirstine Møller Gliese
Contact Person Email
kgli@regionsjaelland.dk
Site Name
Aarhus Universitetshospital
Department Name
Nephrology
Contact Person Name
Dinah Sherzad Khatir
Contact Person Email
dinkha@rm.dk
Site Name
Aalborg University Hospital
Department Name
Nephrology
Contact Person Name
Hanna Sofia Svensson
Contact Person Email
my.svensson@rn.dk

Italy

Earliest CTIS Part Ii Submission Date
17-06-2024
Latest Decision Or Authorization Date
24-02-2026
Processing Time Days
617
Number Of Sites
15
Number Of Participants
75

Sites

Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Nephrology
Contact Person Name
Federico Alberici
Contact Person Email
federico.alberici@unibs.it
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
Nephrology
Contact Person Name
Francesco Trepiccione
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Nephrology
Contact Person Name
Gaetano La Manna
Contact Person Email
gaetano.lamanna@unibo.it
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli (Naples site)
Department Name
Nephrology
Contact Person Name
Silvio Borrelli
Contact Person Email
silvio.borrelli@unicampania.it
Site Name
Universita' Degli Studi G. D'annunzio Di Chieti
Department Name
Nephrology
Contact Person Name
Mario Bonomini
Contact Person Email
m.bonomini@nephro.unich.it
Site Name
Azienda Ospedaliera di Padova
Department Name
Nephrology
Contact Person Name
Anna Basso
Contact Person Email
anna.basso@aopd.veneto.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Nephrology
Contact Person Name
Gabriele Donati
Contact Person Email
gabriele.donati@unimore.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Nephrology
Contact Person Name
Francesca Cappadona
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Nephrology
Contact Person Name
Giuseppe Castellano
Site Name
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Department Name
Nephrology
Contact Person Name
Loreto Gesualdo
Contact Person Email
loreto.gesualdo@uniba.it
Site Name
ASST Fatebenefratelli Sacco
Department Name
Nephrology
Contact Person Name
Maurizio Gallieni
Site Name
Ospedale Santa Maria Annunziata
Department Name
Nephrology
Contact Person Name
Alma Mehmetaj
Site Name
Azienda Ospedaliera S Maria Di Terni
Department Name
Nephrology
Contact Person Name
Luigi Vecchi
Contact Person Email
l.vecchi@aospterni.it
Site Name
Azienda Sanitaria Territoriale Di Ascoli Piceno
Department Name
Nephrology
Contact Person Name
Matthias Zeiler
Site Name
Ospedale San Giovanni Bosco
Department Name
Nephrology
Contact Person Name
Roberta Fenoglio
Contact Person Email
roberta.fenoglio@unito.it

Spain

Earliest CTIS Part Ii Submission Date
17-06-2024
Latest Decision Or Authorization Date
05-03-2026
Processing Time Days
626
Number Of Sites
17
Number Of Participants
40

Sites

Site Name
Hospital Universitario De Toledo
Department Name
Nephrology
Contact Person Name
Francisco Ahijado
Contact Person Email
fjahijadoh@sescam.jccm.es
Site Name
Hospital Universitario Doctor Peset
Department Name
Nephrology
Contact Person Name
Sandra Beltran
Contact Person Email
sanbelca@gmail.com
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Nephrology
Contact Person Name
Marco Montomoli
Contact Person Email
marcomontomoli@hotmail.it
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Nephrology
Contact Person Name
Haridian Sosa Barrios
Contact Person Email
haridian@gmail.com
Site Name
Hospital Germans Trias I Pujol
Department Name
Nephrology
Contact Person Name
Marie Isabelle Troya Saborido
Site Name
Hospital Universitari De Girona Doctor Josep Trueta
Department Name
Nephrology
Contact Person Name
Claudia Marcela Castillo Devia
Site Name
Hospital Universitario Central De Asturias
Department Name
Nephrology
Contact Person Name
Maria Carmen Rodríguez Suárez
Contact Person Email
CARMENRS@telefonica.net
Site Name
Fundacio Puigvert
Department Name
Nephrology
Contact Person Name
Maria Alba Herreros
Contact Person Email
mherreros@fundacio-puigvert.es
Site Name
Hospital Universitario De Burgos
Department Name
Dialysis Unit
Contact Person Name
Maria Jesùs Izquierdo Ortìz
Site Name
Hospital Universitario Basurto
Department Name
Nephrology
Contact Person Name
Olga Gonzalez Pena
Contact Person Email
o.gonzalezpena66@gmail.com
Site Name
Hospital Universitario La Paz
Department Name
Nephrology
Contact Person Name
Gloria del Peso Gilsanz
Site Name
Hospital Universitario Severo Ochoa
Department Name
Nephrology
Contact Person Name
Carolina Lentisco Ramirez
Contact Person Email
clentisco@gmail.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Nephrology
Contact Person Name
Catalina Martín Cleary
Contact Person Email
cmartinc@fjd.es
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Nephrology
Contact Person Name
Jose Maria Portolés Perez
Site Name
Hospital Universitario De Navarra
Department Name
Nephrology
Contact Person Name
Maria Fernanda Slon Roblero
Contact Person Email
mf.slon.roblero@navarra.es
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Nephrology
Contact Person Name
Miguel Perez Fontan
Contact Person Email
miguel.perez.fontan@udc.es
Site Name
Bellvitge University Hospital
Department Name
Nephrology
Contact Person Name
Inés Rama Arias
Contact Person Email
irama@bellvitgehospital.cat

Sponsor

Primary sponsor

Full Name
Iperboreal Pharma S.r.l.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Italy

Contract research organisations

Name
Excelya Germany GmbH
Responsibilities
code: 10

Third parties

  • {"country":"Denmark","full_name":"Specific Pharma A/S","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Sweden","full_name":"Apoteket AB","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Persongene S.r.l.","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Nubilaria S.r.l.","duties_or_roles":"code: 7","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Distefar Del Sur S.L.","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Sintesi Research S.r.l.","duties_or_roles":"codes: 1, 12, 5, 6","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","duties_or_roles":"code: 4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Cryolab S.r.l.","duties_or_roles":"code: 15 (Biobank)","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Excelya Germany GmbH","duties_or_roles":"code: 10","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Arithmos S.r.l.","duties_or_roles":"code: 8","organisation_type":"Pharmaceutical company"}
  • {"country":"Romania","full_name":"Infomed Fluids S.R.L.","duties_or_roles":"code: 15 (Manufacturing plant XyloCore two-chambered)","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Industria Farmaceutica Galenica Senese S.r.l.","duties_or_roles":"code: 15 (Manufacturing plant XyloCore mono-chambered)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Xylocore High Strength
Active Substance
Levocarnitine; Glucose monohydrate; Xylitol
Modality
Small molecule
Routes Of Administration
INTRAPERITONEAL USE
Route
Intraperitoneal
Maximum Dose
6 l (per day)
Investigational Product Name
Xylocore Medium Strength
Active Substance
Levocarnitine; Glucose monohydrate; Xylitol
Modality
Small molecule
Routes Of Administration
INTRAPERITONEAL USE
Route
Intraperitoneal
Maximum Dose
6 l (per day)
Investigational Product Name
Xylocore Low Strength
Active Substance
Levocarnitine; Glucose monohydrate; Xylitol
Modality
Small molecule
Routes Of Administration
INTRAPERITONEAL USE
Route
Intraperitoneal
Maximum Dose
6 l (per day)
Combination Treatment
Yes

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