E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
kidney transplant |
trapianto di rene |
|
E.1.1.1 | Medical condition in easily understood language |
kidney transplant |
trapianto di rene |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
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 | 10023438 |
E.1.2 | Term | Kidney transplant |
E.1.2 | System Organ Class | 100000004865 |
|
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 |
To compare the short-term effects of telmisartan and losartan on insulin sensitivity in kidney transplant recipients with stable renal function and concomitant treatment with steroids and/or calcineurin inhibitors. |
Valutare gli effetti a breve termine del Telmisartan e del Losartan sull'insulino resistenza in pazienti con trapianto di rene con funzione renale stabile e in trattamento con steroidi e/o inibitori della calcineurina. |
|
E.2.2 | Secondary objectives of the trial |
To compare in the above cohort of patients the effects of telmisartan and losartan on lipid profile, glucose tolerance, and renal function |
Valutare gli effetti a breve termine del Telmisartan e del Losartan sul profilo lipidico,sulla tolleranza al glucosio e sulla funzione renale in pazienti con trapianto di rene con funzione renale stabile e in trattamento con steroidi e/o inibitori della calcineurina. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Informed consent; - Age > 18 years; - Single or dual marginal renal transplant > 6 months duration; - Blood pressure >130/85 mmHg or need for anti-hypertensive therapy; - Stable renal function (changes in serum creatinine < 30%) and no acute rejection episodes in the last six months; - Stable (for at least six months) dual or triple immunosuppressive therapy including corticosteroids or calcineurin inhibitors; - Legal capacity. |
- consenso informato; - uomini e donne di eta` > 18 anni; - pazienti che abbiano ricevuto un singolo trapianto di rene o un doppio trapianto di reni marginali da più di sei mesi; - pressione >130/85 mmHg o presenza di terapia antiipertensiva; - funzione renale stabile ( variazioni nel valore della creatinina serica inferiori al 30%) e nessun episodio di rigetto acuto negli ultimi sei mesi; - terapia immunosoppressiva doppia o tripla stabile da almeno sei mesi comprendente coricosteroidi o inibitori della calcineurina. - capacita` legale. |
|
E.4 | Principal exclusion criteria |
- Vascular disease of the kidney; - Heart failure: NYHA classification class III-IV on ACE or AII inhibitor therapy; - Cerebral haemorrhage, stroke or TIA within three months prior to study enrolment; - Myocardial infarction within three months prior to study enrolment; - Unstable angina pectoris; - Severe hepatic disease; - Pregnancy or women of child-bearing potential without following a scientifically accepted form of contraception; - Overt diabetes or concomitant treatment with oral antidiabetic agents and/or insulin; - Specific contraindications or history of hypersensitivity to the study drugs, glitazones, ACE inhibitors or AII receptor antagonists; - Participation to other clinical trials over the last three months; - Legal incapacity; - Previous diagnosis of: intellectual disability/mental retardation, dementia, schizophrenia. |
- malattia vascolare del rene; - evidenza di patologia cardiaca di classe III-IV in terapia con ACE inibitori o antagonisti recettorilai dell'angiotensina II; - emorragia cerebrale, ictus o TIA nei tre mesi precedenti all'arruolamento nello studio; - infarto del miocardio nei tre mesi precedenti all'arruolamento nello studio; - angina pectoris instabile; - stenosi della valvola mitralica, stenosi dell'aorta o cardiomiopatia ipertrofica; - patologia epatica severa; - gravidanza o donne potenzialmente fertili che non utilizzino un sistema contraccettivo scientificamente accettato; - diabete conclamato o trattamenti concomitanti con agenti antidiabetici orali e/o insulina; - nessuna controindicazione specifica al farmaco in studio, ai glitazoni, agli ACE inibitori o agli antagonisti del recettore dell'angiotensina II; - partecipazione ad altri studi nei tre mesi precedenti; - incapacita' legale; - diagnosi precedente di: disabilita' intellettuale/ritardo mentale, demenza, schizofrenia. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Insulin sensitivity (i.e. glucose disposal rate as assessed by an euglycemic hyperinsulinemic clamp) |
Attivita' insulinica |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At baseline, at the end of the two treatment periods and at recovery. |
Al basale, alla fine dei due periodi di trattamento e del periodo di recovery. |
|
E.5.2 | Secondary end point(s) |
Systemic - Sitting systolic/diastolic blood pressure; - 24-h blood pressure profile; Metabolic - Morning fasting blood glucose; - Glucose tolerance test; - Glicated hemoglobin; - Morning fasting insulin, HOMA index; - Lipid profile (total cholesterol, triglycerides, HDL, LDL, apolipoprotein A, B); Renal - UAE; - GFR/RPF; - Albumin fractional clearance. |
Sistemici - pressione sistolica e diastolica; - profilo pressorio delle 24 ore; Metabolici - glicemia a digiuno; - test di tolleranza al glucosio; - emoglobina glicata; - insulina a digiuno, indice HOMA - profilo lipidico (colesterolo totale, trigliceridi, HDL, LDL, apolipoproteina A e B); Renali - UAE; - GFR/RPF; - Albumina, clearance frazionata delle IgG. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
At baseline, at the end of the two treatment periods and at recovery. |
Al basale, alla fine dei due periodi di trattamento e del periodo di recovery. |
|
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 | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
|
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 48 |
E.8.9.1 | In the Member State concerned days | 0 |