E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | End-Stage Renal Disease (ESRD) | Enfermedad renal terminal | |
E.1.1.1 | Medical condition in easily understood language | End-Stage Renal Disease (ESRD) | Enfermedad renal terminal | |
E.1.1.2 | Therapeutic area | Diseases [C] - Male diseases of the urinary and reproductive systems [C12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 | E.1.2 | Level | PT | E.1.2 | Classification code | 10077512 | E.1.2 | Term | End stage renal disease | E.1.2 | System Organ Class | 10038359 - Renal and urinary disorders | |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial | The primary objective of this study is to demonstrate the non-inferiority of XyloCore compared to the standard treatment of glucose PD solutions, with regards to the weekly Kt/Vurea. | El objetivo principal de este estudio es demostrar la no inferioridad de XyloCore en comparación con el tratamiento estándar de soluciones de glucosa para DP, con respecto al Kt/Vurea semanal. | |
E.2.2 | Secondary objectives of the trial | -Changes from the baseline values of LDL, HDL and total cholesterol, serum triglycerides, HbA1c (glycated haemoglobin) and insulin; -Changes from the baseline values of hemoglobin and EPO requirements; -Patients’ subjective assessment of fatigue (Chalder Fatigue Scale, see Appendix 2) -Peritoneal Ultrafiltration -Blood pressure -Diuresis -Residual kidney function | - Cambios con respecto a los valores basales de LDL, HDL y colesterol total, triglicéridos séricos, HbA1c (hemoglobina glicosilada) e insulina; - Cambios de los valores de referencia de los requisitos de hemoglobina y EPO; - Evaluación subjetiva de la fatiga de los pacientes (Escala de fatiga de Chalder, véase el Apéndice 2) - Ultrafiltración Peritoneal -Presión arterial - Diuresis - Función renal residual | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria | Patients who meet all of the following criteria will be enrolled: 1.Age ≥ 18 years 2.Diagnosed of ESRD and treated with CAPD in the last 3 months 3.In a stable clinical condition during the 3 months before screening as demonstrated by the absence of non-elective hospitalisation and major cardiovascular events 4.Have not experienced peritonitis episodes in the last 3 months 5.In treatment with Extraneal (nocturnal long-dwell exchange for at least one month); 6.In treatment with 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) 7.Weekly Kt/V urea measurement > 1.7 8.Followed-up/treated by the participating clinical Center/Investigator in the last three months 9.Understanding the nature of the study and providing informed consent to participate in the study. | Se incluirán los pacientes que cumplan todos los criterios siguientes: 1. Edad ≥18 años 2. Diagnóstico de ESRD y tratamiento con CAPD en los últimos 3 meses 3. En estado clínico estable durante los 3 meses anteriores al cribado, demostrado por la ausencia de hospitalización no electiva y de eventos cardiovasculares mayores 4. No han padecido episodios de peritonitis en los últimos 3 meses 5. En tratamiento con Extraneal (intercambio nocturno de larga permanencia durante al menos un mes); 6. En tratamiento con 2 o 3 intercambios prescritos cortos con Physioneal (incluida bolsa Clear-Flex), Fixioneal, Dianeal o Dianeal Baja en Calcio (glucosa 1.36%, 2.27% o 3.86%), o Balance, Bicavera, Bicanova o Equibalance (glucosa 1.5%, 2.3%, 4.25%) 7. Medición semanal de Kt/V urea > 1.7 8. Seguimiento/tratamiento por parte del Centro Clínico/Investigador participante en los últimos tres meses 9. Comprender la naturaleza del estudio y dar el consentimiento informado para participar en el mismo. | |
E.4 | Principal exclusion criteria | Patients who fulfill any of the following criteria will not be enrolled: 1.History of drug or alcohol abuse in the six months prior to entering the protocol 2.In treatment with androgens 3.Clinically significant abnormal liver function test (Gamma-GT > 4 times the upper normal limit) 4.Acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low tract urinary infections, renal parenchymal infection, pericarditis, etc) 5.Expected patient’s survival shorter than trial duration 6.L-Carnitine therapy in the month prior to entering the protocol 7.Have used any investigational drug in the 3 months prior to entering the protocol 8.Female patients who are pregnant or breast-feeding. 9.Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception* 10.Patients affected by Primary Hyperoxaluria as per known medical hystory 11.Patients with serum levels of uric acid > 7.2 mg/dl (male and postmenopausal women) or > 6.0 mg/dl (premenopausal women) 12.Patients with a major cardiovascular event in the last 3 months 13.Patients with advanced cardiac failure (NYHA 4). | 1. Antecedentes de abuso de drogas o alcohol en los seis meses anteriores a la entrada en el protocolo 2. En tratamiento con andrógenos 3. Resultados anormales de función hepática clínicamente significativos (Gamma-GT > 4 veces por encima del límite superior normal) 4. Enfermedad infecciosa aguda (por ejemplo: infección pulmonar, hepatitis aguda, infecciones urinarias de vías altas o bajas, infección del parénquima renal, pericarditis, etc.) 5. La supervivencia esperada del paciente es menor que la duración del ensayo. 6. Tratamiento con L-Carnitina en el mes anterior a la entrada en el protocolo 7. Haber utilizado algún fármaco experimental en los 3 meses anteriores a entrar en el protocolo 8. Mujeres embarazadas o en periodo de lactancia. 9. Pacientes femeninas en edad fértil (menos de 24 meses después del último ciclo menstrual) que no utilizan métodos anticonceptivos adecuados*. 10. Pacientes que padecen hiperoxaluria primaria según la historia clínica conocida 11. Pacientes con niveles séricos de ácido úrico > 7.2 mg/dl (hombres y mujeres posmenopáusicas) o > 6.0 mg/dl (mujeres premenopáusicas) 12. Pacientes con un evento cardiovascular importante en los últimos 3 meses 13. Pacientes con insuficiencia cardíaca avanzada (NYHA 4) | |
E.5 End points |
E.5.1 | Primary end point(s) | The primary outcome measure is total weekly Kt/Vurea after a 24-week period using the assigned PD solution, assessed using a peritoneal function test. | La medida de resultado primario es el Kt/Vurea semanal total después de un período de 24 semanas utilizando la solución de DP asignada, evaluada mediante una prueba de función peritoneal. | |
E.5.1.1 | Timepoint(s) of evaluation of this end point | |
E.5.2 | Secondary end point(s) | -Changes from the baseline values of LDL, HDL and total cholesterol, serum triglycerides, HbA1c (glycated haemoglobin), and insulin; -Changes from the baseline values of hemoglobin and EPO requirements; -Patients’ subjective assessment of fatigue (Chalder Fatigue Scale, Appendix 2) -Peritoneal Ultrafiltration -Diuresis (or 24 hours urinary volume) -Residual kidney function [measured as the arithmetic mean of urinary urea and creatinine clearance], Appendix 4 (Steubl 2019) | -Cambios de los valores basales de LDL, HDL y colesterol total, triglicéridos séricos, HbA1c (hemoglobina glicosilada) e insulina; -Cambios de los valores de referencia de los requisitos de hemoglobina y EPO; -Valoración subjetiva de fatiga de los pacientes (Chalder Fatigue Scale, Apéndice 2) -Ultrafiltración Peritoneal -Diuresis (o volumen urinario de 24 horas) -Función renal residual [medida como la media aritmética del aclaramiento de creatinina y urea en orina], Apéndice 4 (Steubl 2019) | |
E.5.2.1 | Timepoint(s) of evaluation of this end point | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description | evaluación ciega de punto final | blinded end-point assessment | |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 | The trial involves single site in the Member State concerned | No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 34 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned | Israel | Denmark | Germany | Italy | Sweden | United Kingdom | Spain | |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 | Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial | |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |