Pharmacokinetics of Somatropin in Patients With End Stage Renal Disease Receiving Chronic Haemodialysis

An Open, Non-randomized, Single-centre, Parallel Group Trial Investigating the Steady-state Blood Concentration Profile and Effects of Once Daily Subcutaneously Injected Recombinant Human Growth Hormone (Norditropin® SimpleXx®) in Patients With End Stage Renal Disease Receiving Chronic Haemodialysis and in Matched Healthy Subjects

This trial is conducted in Europe. The aim of this trial is to to compare steady-state total growth hormone (GH) exposure in haemodialysis (HD) patients with that of matched healthy subjects.

Inclusion Criteria:

• PATIENTS:
• Male or female, age equal to or above 18 years undergoing chronic haemodialysis
• Stable and adequate haemodialysis treatment three months prior to enrolment
• HEALTHY SUBJECTS:
• Matching an individual of the patient group by: Gender and age (± 5 years)
• Matching an individual of the patient group by weight (after dialysis, ±10%)
• Creatinine clearance above 80 ml/min
• Subjects must be in good health in accordance with their age as determined by a medical
• history, physical examination, vital signs, ECG (electrocardiogram), routine haematology and clinical chemistry

Exclusion Criteria:

• Use of cuprophane membranes
• Active malignant disease
• Diabetes
• Critical illness as defined by the need of respiratory or circulatory support
• Known or suspected allergy to the trial product
• Pregnancy, breast feeding, the intention of becoming pregnant or fertile women judged to be
• using inadequate contraceptive measures
• Blood Pressure (pre-dialysis) above 180/110
• Chronic treatment with steroids in doses above 10 mg/day prednisolone (or equivalent)
• Treated with immunosuppressive agents