E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetic kidney disease in patients with type 2 diabetes |
Nefropatía diabética en pacientes con diabetes tipo 2 |
|
E.1.1.1 | Medical condition in easily understood language |
Diabetic kidney disease, a complication that occurs in many people with diabetes |
Nefropatía diabética, una complicación que aparece en mucha genete con diabtes. |
|
E.1.1.2 | Therapeutic area | Not possible to specify |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045250 |
E.1.2 | Term | Type II diabetes mellitus with renal manifestations |
E.1.2 | System Organ Class | 100000004857 |
|
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 objective of this study is to detect the existence of an overall dose-response relationship with gevokizumab SC, on the measured glomerular filtration rate in patients with type 2 diabetes and diabetic kidney disease |
El objetivo de este estudio es detectar la existencia de una relación dosis-repuesta global con gevokizumab SC, mediante la medida de la Tasa de Filtración Glomerular en pacientes con diabtes tipo 2 y nefropatía diabética. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives are to assess the effect of gevokizumab on the other efficacy endpoints and to evaluate its safety. |
Los objetivos secundarios son evaluar el efecto de gevokizumab en otros criterios de eficacia y evaluar su seguridad. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Known type 2 diabetes with a diagnosis made at age ?30 years or later and ?8 years prior to selection - Estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease (MDRD) equation within the 20-60 mL/min/1.73 m2 range - Urinary albumin-to-creatinine ratio (UACR) >300 mg/g. - Treatment by angiotensin converting enzyme (ACE) inhibitor or by angiotensin-II receptor blocker (ARB) unless medically justified and documented; at a stable dose for at least 6 weeks prior to selection visit |
-Diabetes tipo 2 conocida diagnosticada a la edad de ? 30 años o más tarde y ? 8 años anteriores a la selección, -Tasa de filtración glomerular estimada (TFGe) de 20-60 ml /min /1,73 m2 usando la fórmula de Modificación de la Dieta en Enfermedad Renal (MDRD). -Cociente albúmina-creatinina en orina (UACR) > 300 mg /g (> 30 mg /mmol). -Tratamiento con un IECA o un ARA II, a menos que esté médicamente justificado y documentado ; y en una dosis estable durante al menos 6 semanas antes de la visita de selección. |
|
E.4 | Principal exclusion criteria |
- Fever or infection requiring treatment with systemic anti-infectives within 3 weeks prior to selection - Major general surgery within 3 months prior to selection, or anticipated during the study period - Treatment with biological agents within within 6 weeks (for anti TNF ? ie: pentoxifylline, anti-IL1) or within 3 months prior to inclusion visit for (but not restrictive to) interferon, infliximab, daclizumab, etanercept, anakinra, canakinumab or adalimumab, either marketed or investigational medicinal products),(other than antivitreal anti VEGF which are allowed) - Any immunosuppressive therapy within 3 months prior to inclusion - Any systemic corticosteroids (>20 mg/day of prednisolone or equivalent) within 1 month prior to inclusion - Any live (attenuated) vaccine within 3 months prior to inclusion; recombinant or killed virus vaccines are permitted |
-Fiebre o infección que requiere tratamiento con medicamentos antiinfecciosos sistémicos dentro de 3 semanas antes de la selección. -Cirugía general mayor en los 3 meses anteriores a la selección, o programada durante el período de estudio. -Cualquier tratamiento con agentes biológicos dentro de las 6 semanas (para anti TNF ? por ejemplo: pentoxifylline, anti-IL1), o dentro de los 3 meses previos a la visita de inclusión (pero no restrictivo a) con interferon, infliximab, daclizumab, etanercept, anakinra, canakinumab or adalimumab, o cualquier producto comercializado ó en investigación (que no sean anti-VEGF intravítreales que sí están permitidos) -Cualquier terapia inmunosupresora durante los 3 meses previos a la inclusión. -Cualquier corticoesteroide sistémico (>20mg/día de prednisolona o equivalente) durante 1 mes antes de la inclusión. -Cualquier vacuna viva (atenuada) durante los 3 meses previos a la inclusión, vacunas con virus recombinantes ó muertos están permitidos. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Measured Glomerular Filtration Rate (mGFR) |
Medida de la Tasa de Filtración Glomerular (TFGm) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From inclusion to Week 52 |
Desde la inclusión a la Semana 52. |
|
E.5.2 | Secondary end point(s) |
- Estimated GFR (eGFR) calculated with serum creatinine and/or serum cystatin C-based equations - Albuminuria, estimated by measuring the urinary albumin to creatinine ratio (UACR) |
-Tasa de Filtarción Glomerular estimada (TFGe) calculada con ecuaciones basadas en creatinina y/o cistatina C. -Albuminuria, estimada mediante la medida del cociente albumina cratinina en orina (UACR) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
From inclusion to the end of the study |
Desde la inclusión hasta el final del estudio |
|
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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
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 | 5 |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 63 |
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 |
Argentina |
Australia |
Belgium |
Canada |
Czech Republic |
Denmark |
Germany |
Hong Kong |
Korea, Republic of |
Poland |
Portugal |
Romania |
Singapore |
Slovakia |
South Africa |
Spain |
Sweden |
Taiwan |
|
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
|
Last Visit Last Participant as stated in the protocol |
Ultima visita del último paciente tal y como recoge el protocolo. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |