The Effect of Somatropin Treatment in Adult Patients on Chronic Dialysis (OPPORTUNITY)
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.
|Chronic Kidney Disease End-Stage Renal Disease||Drug: somatropin Drug: placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of Somatropin in Adult Patients on Chronic Haemodialysis|
- Mortality - Time to All-cause Death [ Time Frame: week 0, trial termination ]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.
- 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) [ Time Frame: week 0, trial termination ]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.
- Morbidity - Number of Hospitalisations, in Addition to Normal Dialysis Procedures [ Time Frame: week 0, trial termination ]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.
- Mortality - Two-year Mortality Rate [ Time Frame: week 0, trial termination ]
- Health Related Quality of Life Assessments [ Time Frame: week 0, trial termination ]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.
|Study Start Date:||July 2007|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Somatropin once daily from week 0 to end of trial
20 mcg/kg/day, injected s.c. (under the skin)
Placebo Comparator: Placebo
Placebo once daily to end of trial
Placebo injected s.c (under the skin)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00503698
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|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|