E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pacientes trasplantados renales a los que por indicación clínica se les va a realizar un cambio de un fármaco anti-calcineurínico (Ciclosporina o Tacrolimus) a un inhidor de la diana de rapamicina (everolimus). |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038533 |
E.1.2 | Term | Renal transplant |
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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 |
Estudiar si la inhibición de mTOR reduciría la utilización muscular de glucosa a la vez que aumentaría la oxidación de ácidos grasos, aumentando la capacidad de esfuerzo físico en pacientes trasplantados renales. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
a. Paciente trasplantado renal, edad >18 años y < a 60 años. b. Frecuencia cardíaca en pulso radial y en sedestación entre 50 y 100 ppm. c. Tensión arterial entre 100 y 140 para sistólica y entre 50 y 90 para diastólica. d. Inexistencia de cualquier cuadro clínico físico, psicológico o psiquiátrico que pueda impedir un seguimiento estricto del protocolo descrito. e. Filtrado glomerular estimado superior a 40 ml/min. f. Proteinuria < 0.5 g/d. g. Trasplante renal realizado cómo mínimo hace 6 meses. h. Inmunosupresión basada en inhibidores de calcineurina. i. Hemoglobina > 11 g/dl. j. BMI < 35 kg/m2. k. Indicación de conversión a everolimus y otorgación del consentimiento informado por escrito. |
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E.4 | Principal exclusion criteria |
a. Participación en cualquier ensayo clínico en los últimos 30 días previos a su inclusión. b.Cualquier otra enfermedad física, psicológica o psiquiátrica que impida el seguimiento por parte del sujeto. c. Diabetes mellitus. d.Tratamiento con agentes estimulantes de la eritropoyesis. e.Tratamiento con β-bloqueantes. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1-Análisis antropométrico (peso, talla, diametros, pliegues y diametros) 2-Análisis de la fuerza (fuerza de contracción palmar y resistencia a la fuerza). 3- Análisis metabólico y test de sobrecarga oral de glucosa. 4- Análisis de paramentros cardiovasculares ( Presión arterial, MAPA y velocidad de la onda de pulso). |
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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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
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
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |