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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Kidney Disease, Healthy, End-Stage Renal Disease

Intervention / Treatment
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* Drug: somatropin
* Drug: somatropin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESRD patients<br> | Drug: somatropin<br>* Injected subcutaneously, 50 mcg/kg/day (up to a maximum of 4 mg/day) once daily. Additional dose administered during dialysis. In total, patients will receive 8 doses.<br>|
| Experimental: Healthy subjects<br> | Drug: somatropin<br>* Injected subcutaneously, 50 mcg/kg/day (up to a maximum of 4 mg/day) once daily. Additional dose administered during dialysis. In total, subjects will receive 7 doses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth hormone exposure at steady state |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the Curve (AUC) |  |  | 
| t½ (terminal half-life) |  |  | 
| Cmax (maximum plasma concentration) |  |  | 
| tmax (time to reach maximum) |  |  | 
| IGF-I (Insulin-Like Growth Factor I) |  |  | 
| Adverse events (AE) |  |  |