Adult Patients in Chronic Dialysis (APCD) MedDRA version: 9.1 Level: LLT Classification code 10066623 Term: Chronic haemodialysis
Conditions
Interventions
Trade Name: Norditropin NordiFlex®
Product Code: NN1630
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Somatropin
CAS Number: 12629-01-5
Concentration unit: mg milligram(s)
Concent
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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 on chronic (= 3 months prior to screening) in-centre haemodialysis (including all types of haemodialysis: e.g., short daily, nocturnal, etc.), age = 18 3.Serum albumin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Previous randomization in this trial. Re-screening of previous screening failures (due to inclusion criterion number 3 and/or exclusion criteria numbers 3, 5-8, 10d, 10e, 11 or 12) is allowed twice within the trial recruitment period: • The first re-screen may occur at any time after the initial screen failure date. However, all screening procedures must be repeated if the re-screening date occurs greater than seven weeks from Visit 1 of the first screen. • The second re-screen must be performed no sooner than 6 months after the V1 of the first screen. However, screening procedures must be repeated if the re-screening date occurs greater than seven weeks from Visit 1 of the first re-screen. 2. Active malignant disease (defined as less than 5 years since receiving a diagnosis of being malignancy-free). 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- ialysis] > 180 mmHg or diastolic blood pressure [pre-dialysis] >110mmHg) in two of the last three pre-dialysis blood pressure recordings taken at the preceding three consecutive dialysis sessions. 7. Patients on chronic treatment with corticosteroids in doses > 10 mg/day prednisolone (or equivalent) during the month preceding screening. 8. Patients treated with immunosuppressive agents during the month preceding screening. 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, as defined by chronic treatment with immunosuppressants. 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. Patients who have undergone successful laser treatment for retinopathy are eligible. 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, including present (last use < 2 years) illicit substance abuse. 12. The receipt of any investigational product within 1 month prior to screening in this trial. Over the counter medications or other non-investigational products are allowed. 13. Scheduled for renal transplantation from a living donor within the trial period or on an urgent list for deceased organ donor kidney transplantation. 14. Pre-existing benign intracranial tumours. Intracranial lesions must be inactive for five years, and anti-tumour therapy complete prior to the initiation of therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate and establish the effect of Norditropin® (somatropin) on mortality in adult patients on chronic haemodialysis;Secondary Objective: To evaluate and establish •The effect of growth hormone on morbidity, Health Related Quality of Life (HRQoL) and other variables in APCD ;Primary end point(s): •Mortality - Time to all-cause death for the pooled non-diabetic/diabetic population | — |
Countries
Denmark, France, Germany, Hungary, Italy, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed