The Effect of Somatropin Treatment in Adult Patients on Chronic Dialysis

Study Overview
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Brief Summary
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This trial is conducted in Africa, Asia, Europe, North and South America and Oceania. The aim of the trial is to evaluate the effect of somatropin (human growth hormone) on survival (primary end-point; time to death and health related quality of life in adult patients on chronic haemodialysis.

Detailed Description
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The decision to discontinue the trial is not due to safety concerns. The discontinuation is based on an analysis of the significant delay in recruitment of patients which is expected to have a negative impact on the outcome of the trial.

Official Title
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Efficacy and Safety of Somatropin in Adult Patients on Chronic Haemodialysis

Conditions
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Chronic Kidney Disease, End-Stage Renal Disease

Intervention / Treatment
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* Drug: somatropin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Serum albumin as specified in protocol Malnourished (based on serum albumin value below 40 g/L, assessed centrally) Stable (for 3 months or more) and adequate haemodialysis treatment three months prior to enrolment as defined by Kt/V of more than 1.2 Exclusion Criteria: Active malignant disease Critical illness requiring treatment in an intensive care unit (ICU) Uncontrolled treated/untreated hypertension Patients on chronic (more than 3 months) treatment with steroids in doses of more than 10 mg/day prednisolone (or equivalent) Patients treated with immunosuppressive agents Known Growth Hormone Deficiency Patients suffering from any clinically significant disease history in the opinion of the investigator Severe illness as defined in the protocol (as judged by the investigator)

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Somatropin<br>Somatropin once daily from week 0 to end of trial | Drug: somatropin<br>* 20 mcg/kg/day, injected s.c. (under the skin)<br>|
| Placebo Comparator: Placebo<br>Placebo once daily to end of trial | Drug: placebo<br>* Placebo injected s.c (under the skin)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality - Time to All-cause Death | Time to all-cause death. Statistical analysis is based on all available information from week 0 to trial termination. Summary data illustrates percentage (%) participants dead estimated using Kaplan-Meier. Summary data illustrates mortality until 52 weeks, because very few subjects had trial time longer than 52 weeks. Due to early trial termination, median trial time was 17.4 weeks. | week 0, trial termination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity - Time From Randomisation to Next Cardiovascular Event (Defined as Composite of All-cause Mortality, Non-fatal Myocardial Infarction, Stroke, Cardiac Insufficiency and Other Thrombo-embolic Event) | Morbidity - time from week 0 to next cardiovascular event (composite of all-cause mortality and cardiovascular events defined as adjudicated medical event of special interest and categorised as myocardial infarctions, cardiac insufficiencies, strokes or other thrombo-embolic events). Statistical analysis is based on all available information from week 0 to trial termination. Summary data illustrates percentage (%) participants with events estimated using Kaplan-Meier. Summary data illustrates morbidity until 52 weeks, because very few subjects had trial time longer than 52 weeks. | week 0, trial termination | 
| Morbidity - Number of Hospitalisations, in Addition to Normal Dialysis Procedures | The number of times that the patient was hospitalised in addition to hospitalisation for normal dialysis procedures measured from week 0 (randomisation) to the time the trial was terminated. | week 0, trial termination | 
| Mortality - Two-year Mortality Rate |  | week 0, trial termination | 
| Health Related Quality of Life Assessments | Summary from activity of daily living from the Rotterdam Symptom Checklist (RSCL) measuring activity from 1 (active) to 5 (inactive). The Edmonton Symptom Assessment System (ESAS), subjects assess their health in the last 24 hours on a scale from 1 (good health) to 3 (feeling poorly). The EQ-5D is a measure of subjects' health outcome from 0 (death) to 1 (full health). SF-36 (Short Form (36)) covering mental and physicial health is provided in a scale from 0-100 with higher scores indicating greater satisfaction. | week 0, trial termination |