E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of Delayed Graft Function (DGF) following renal transplantation |
Prevención de la función retardada del injerto (DGF) siguiente renal trasplante |
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E.1.1.1 | Medical condition in easily understood language |
Prevention of 'reperfusion injury' (tissue damage) occurring within the first few days of transplantation with a consequential lack of proper functioning of the transplanted kidney. |
Prevención de la 'lesión por reperfusión (daño tisular) se produzcan en el primeros días del trasplante con una falta consiguiente de buen funcionamiento del riñón trasplantado. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Symptoms and general pathology [C23] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10048747 |
E.1.2 | Term | Renal graft function delayed |
E.1.2 | System Organ Class | 100000004863 |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess out to one-year the clinical status of patients who completed the double-blind part A or B of the 6-month study period in the Opsona phase II protocol (OPN305-102) by recording the following: - Incidence of allograft rejection or loss - Initiation and frequency of dialysis or other renal replacement therapy (RRT) - Estimated GFR at the end of the 6-month follow-up period based on a determination of serum creatinine by the local study site - Incidence and type of serious adverse events (SAEs) - The occurrence of infections by type and actual organism - The incidence of hospitalisations |
Para evaluar a un año el estado clínico de los pacientes que completaron la parte A o B del período de 6 meses de estudio en el protocolo Opsona fase II (OPN305-102) mediante el registro de la siguiente doble ciego: - La incidencia de rechazo del injerto o la pérdida - Iniciación y la frecuencia de la diálisis u otro tratamiento renal sustitutivo (TRS) - TFG estimada al final del período de 6 meses de seguimiento basado en la determinación de la creatinina sérica por el sitio de estudio local - La incidencia y tipo de efectos adversos graves (EAG) - La aparición de infecciones por tipo y organismo real - La incidencia de hospitalizaciones |
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E.2.2 | Secondary objectives of the trial |
No secondary objectives |
No hay objetivos secundarios |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Completion of the double-blind part A or B of the 6-month study visit in the phase II trial (OPN305-102) - Provide written informed consent for the follow-up protocol. |
- Finalización de la parte de doble ciego A o B de la visita de estudio de 6 meses en el ensayo de fase II (OPN305-102) - Proporcionar el consentimiento informado por escrito para el protocolo de seguimiento. |
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E.4 | Principal exclusion criteria |
- Refusal to give written informed consent - Withdrawn from OPN305-102 prior to the 6 month final visit - Plan to be included into another interventional investigational study |
- La negativa a dar su consentimiento informado por escrito - Retirado de OPN305-102 antes de la visita final 6 meses - Plan de que se incluya en otro estudio de investigación intervencionista. |
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E.5 End points |
E.5.1 | Primary end point(s) |
? Incidence of allograft rejection or loss ? Initiation and frequency of dialysis or other renal replacement therapy (RRT) ? Estimated GFR at the end of the 6-month follow-up period based on a determination of serum creatinine by the local study site ? Incidence and type of serious adverse events (SAEs) ? The occurrence of infections by type and actual organism ? The incidence of hospitalisations |
? La incidencia de rechazo del injerto o la pérdida ? Puesta en marcha y la frecuencia de la diálisis u otro tratamiento sustitutivo renal (TSR) ? TFG estimada al final del período de 6 meses de seguimiento basado en la determinación de la creatinina sérica en el sitio de estudio local ? La incidencia y tipo de efectos adversos graves (AAG) ? La incidencia de las infecciones por el organismo de tipo y reales ? La incidencia de hospitalizaciones |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
3 months (Nine-Month Post-Treatment) and 6 months (Twelve-Month Post-Treatment) Follow-up Study Visits |
3 meses (nueve meses posteriores a la Integridad Personal) y 6 meses (doce meses post-tratamiento) Seguimiento de las visitas de estudio |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
All patients entered in this follow-up study will attend a 3-month and 6-month study visit corresponding to 9 and 12 months after their study-drug administration in the initial phase II trial (OPN305-102). To indicate this continuity the study visits will be described in this follow-up protocol as being at 9 and 12 months following administration of OPN-305/placebo. |
Todos los pacientes incluidos en este estudio de seguimiento asistirán a un estudio de 3 meses y 6 meses de visita correspondiente a los 9 y 12 meses después de su administración el medicamento en investigación en el estudio inicial de fase II (OPN305-102). Para indicar la continuidad de las visitas de estudio se describen en este protocolo de seguimiento como a los 9 y 12 meses después de la administración de OPN-305/placebo. |
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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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
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 |
Belgium |
France |
Germany |
Austria |
Netherlands |
Poland |
Czech Republic |
Spain |
Switzerland |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |