E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Adult Patients in Chronic Dialysis (APCD) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066623 |
E.1.2 | Term | Chronic haemodialysis |
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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 |
To evaluate and establish the effect of Norditropin® (somatropin) on mortality in adult patients on chronic haemodialysis |
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E.2.2 | Secondary objectives of the trial |
To evaluate and establish •The effect of growth hormone on morbidity, Health Related Quality of Life (HRQoL) and other variables in APCD
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Informed consent obtained before any trial-related activities (trial-related activities are any procedure that would not have been performed during normal management of the subject) 2.Male or female in chronic haemodialysis, age ≥ 18 3.Serum albumin < 40 g/L (median of three measurements analysed by a central laboratory) 4.Stable (≥ 3 months) and adequate haemodialysis treatment three months prior to enrolment as defined by Kt/V > 1.2 at the screening visit For subjects to be diagnosed with diabetes and considered eligible as subjects with diabetes, furthermore: 5.Current treatment with OAD and/or insulin OR patients on dietary management with a Fasting Plasma Glucose (FPG) ≥126 mg/dL (~ 7.0 mmol/L) (median of three measurements analysed by a central laboratory) 6.Willingness to commence insulin therapy if deemed necessary by the Investigator and/or a central assessor
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E.4 | Principal exclusion criteria |
1.Previous randomisation in this trial. Re-screening of previous screening failures (due to exclusion criteria no. 3, 5-8, 10.d, e, 11 or 12) is allowed once during the recruitment period 2.Active malignant disease 3.Critical illness as defined by the need of respiratory or circulatory support (admitted to an intensive care unit (ICU)) 4.Known or suspected allergy to trial product(s) or related products 5.Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice including abstinence, oral contraceptives, intrauterine devices (IUD), barrier (diaphragm or condom) plus spermicide, injectable or implantable contraceptives) 6.Uncontrolled treated/untreated hypertension (systolic blood pressure (pre-dialysis) > 180 mmHg or diastolic blood pressure >110mmHg, median of baseline and latest two preceding BP measurements) 7.Patients on chronic (> 3 months) treatment with steroids in doses > 10 mg/day prednisolone (or equivalent) 8.Patients treated with immunosuppressive agents 9.Known Growth Hormone Deficiency 10.Patients suffering from a.Active vasculitis b.Severe congestive heart failure corresponding to New York Heart Association (NYHA) class IV (see Appendix C for definition of NYHA classes) c.Severe chronic systemic inflammatory disease d.Severe acute systemic infectious/inflammatory disease e.Severe hepatic disease, defined as ALT or AST levels > 3 times upper normal range (one re-test analysed at the central laboratory within one week is permitted with the last sample being conclusive) f.Active proliferative or severe non-proliferative diabetic retinopathy g.Mental incapacity, unwillingness or language barrier precluding adequate understanding 11.Any condition judged by the Investigator to interfere with trial participation or evaluation of results or to be potentially hazardous to the patient 12.The receipt of any investigational drug within 1 month prior to screening in this trial 13.Scheduled (dated) renal transplantation within the trial period
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E.5 End points |
E.5.1 | Primary end point(s) |
•Time to death Analysis will be performed on all patients where survival information is available, including withdrawals. Drop-outs are in the analysis defined as “subjects with no two-year follow-up on survival”
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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.8.3 |
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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 92 |
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 | Information not present in EudraCT |
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 |
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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 | 1 |
E.8.9.1 | In the Member State concerned days | |
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 | 1 |