E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Monocyte function in patients with anemia in hemodialysis |
Funcionalidad monocitaria en pacientes con anemia en hemodiálisis |
|
E.1.1.1 | Medical condition in easily understood language |
Anemia in patients in hemodialysis |
Anemia en pacientes en hemodiálisis |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002272 |
E.1.2 | Term | Anemia |
E.1.2 | System Organ Class | 100000004851 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027884 |
E.1.2 | Term | Monocytes |
E.1.2 | System Organ Class | 100000004848 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10005671 |
E.1.2 | Term | Blood monocytes normal |
E.1.2 | System Organ Class | 100000004848 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10005669 |
E.1.2 | Term | Blood monocytes decreased |
E.1.2 | System Organ Class | 100000004848 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027881 |
E.1.2 | Term | Monocyte count low |
E.1.2 | System Organ Class | 100000004848 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027879 |
E.1.2 | Term | Monocyte count high |
E.1.2 | System Organ Class | 100000004848 |
|
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 |
Assess if the administration of intravenous iron,based only in levels of transferrin saturation index, does not generate relevants changes (higher than 15%) in the proportion of monocytes (CD14+ and CD16+) compared with patients that received treatment with intravenous iron according to the practice guidelines in place. |
Evaluar si la administración de hierro i.v. basada únicamente en el índice de saturación de la transferrina, no condiciona cambios relevantes, superiores al 15 %, en la proporción de monocitos CD14+ y CD16+, en comparación con los pacientes tratados según las guías clínicas vigentes en la actualidad. |
|
E.2.2 | Secondary objectives of the trial |
Evaluate: . The mortality rate of patients in 2 years-interval. - The number and severity of infections in 2 years-interval. - The mean haemoglobin levels - Number of Erythropoiesis-stimulating agents administered and blood transfusions. - The iron build up in liver tissue measured by magnetic resonance (NMR), as well as the hepatocellular function - The iron accumulates in serum monocytes. |
Evaluar: - La mortalidad de los pacientes en el intervalo de 2 años. - El número y la severidad de los episodios infecciosos, cuantificada según la estancia hospitalaria, en el intervalo de 2 años. - Los niveles medios de hemoglobina durante todo el periodo, así como los niveles totales de agentes estimuladores de la eritropoyesis y transfusiones administradas. - La acumulación de hierro en tejido hepático medida mediante resonancia magnética (RMN), realizada anualmente, así como la función hepatocelular. - El grado de acumulación de hierro en el sistema retículo-endotelial fagocítico, medido por el acúmulo de hierro en células mononucleadas circulantes. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Older than 18. - Hemodialysis indicence patients (between 2 and 6 months in hemodialysis). - Having signed the inform consent. - Patients with anemia who require intravenous iron - Have not received intravenous iron before hemodialysis. - Clinically stable. |
-Pacientes incidentes en programa de hemodiálisis, con más de 2 meses de tratamiento con hemodiálisis y menos de 6 meses en hemodiálisis mantenida. - Edad mayor de 18 años. - Haber firmado el consentimiento informado. - Pacientes con anemia susceptible de ser tratada con hierro i.v. con objetivo de índice de saturación de la transferrina del 30% - No haber recibido hierro i.v. antes del inicio de hemodiálisis. - Pacientes clínicamente estables, con una expectativa de vida superior a 2 años. |
|
E.4 | Principal exclusion criteria |
- Patients with a ferritin level higher than 500mg/dl - Patients who have exceeded transferrin levels in the prior year to be included in the clinical trial. - Patients who, before the hemodialysis, had received intravenous iron. - Patients with chronic HIV or hepatitis C infection. - Pregnant women or breastfeeding period |
- Pacientes con niveles de ferritina >500 mg/dl al inicio del estudio. - Pacientes que hayan superado niveles de ferritina >500 mg/dl en el año previo a su inclusión en el estudio - Pacientes que hayan recibido hierro i.v. antes del inicio de hemodiálisis. - Pacientes embarazadas o en período de lactancia. - Pacientes con infección crónica por VHC y VHB. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Serum monocyte |
Nivel de monocitos |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Monthly for 2 years period. |
mensualmente en el periodo de 2 años. |
|
E.5.2 | Secondary end point(s) |
Mortality and number of infections. |
Mortalidad y número de infecciones. |
|
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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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
|
- LVLS - Whenever the risk/benefit balance, of the experimental group vs the control group, were unfavourable. - At the discretion of the sponsor |
- Ultima visita del último paciente incluido. - Cuando por razones de seguridad se detecte una relación beneficio-riesgo desfavorable del grupo experimental frente a lo establecido en las guías de práctica clínica. - A criterio del promotor. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |