Trial · Interventional

TerminatedPhase 3Results postedRegistry data

The Effect of Somatropin Treatment in Adult Patients on Chronic Dialysis

Short name OPPORTUNITY

NCTNCT00503698Other idNN1630-1453Other id2006-004702-56

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: See termination reason in detailed description

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 3
Enrollment: 712 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Double masking
Countries: 21 countries
United States, Argentina, Brazil, Canada, China, Denmark, France, Germany, Hungary, India, Israel, Italy, Poland, Portugal, Puerto Rico, Russia, South Africa, Spain, Sweden, Turkey (Türkiye), United Kingdom
Start: Jul 2007
Primary completion: Dec 2008
Completion: Dec 2008
First posted: 19 Jul 2007 (estimated)
Last update posted: 7 Mar 2017
Conditions: Chronic Kidney Disease · End-Stage Renal Disease

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200720082009

Ph 3
OPPORTUNITY
NCT00503698
Jul 2007 to Dec 2008
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

somatropinDrug
placeboDrug

Arms2

Experimental
Somatropin
Somatropin once daily from week 0 to end of trial
Placebo comparator
Placebo
Placebo once daily to end of trial

Primary outcomes1

Outcomes the sponsor listed as primary.

Mortality - Time to All-cause Death
Time frame · week 0, trial termination
Registry description
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.

Secondary outcomes(4)

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
Registry description
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
Registry description
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
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· week 0, trial termination

Mortality - Time to All-cause Death

Group	Value (percentage of participants)	Spread
Somatropin	0	NA
Placebo	0	NA

Secondary and other outcome results(4)

Secondary outcomeNumber· week 0, trial termination

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)

Group	Value (percentage of participants)	Spread
Somatropin	0	0
Placebo	0	0

Secondary outcomeMean· week 0, trial termination

Morbidity - Number of Hospitalisations, in Addition to Normal Dialysis Procedures

Group	Value (hospitalisations)	Spread
Somatropin	0.5	0.9
Placebo	0.5	1.0

Secondary outcome· week 0, trial termination

Mortality - Two-year Mortality Rate

Group	Value
Somatropin	not posted
Placebo	not posted

Secondary outcomeMean· week 0, trial termination

Health Related Quality of Life Assessments

Group	Value (scores on a scale)	Spread
Somatropin	2.9	0.9
Placebo	3.0	0.9

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
SomatropinSomatropin 20 mcg/kg once daily, week 0 to end of trial	–	122 / 346	225 / 346
PlaceboPlacebo once daily, week 0 to end of trial	–	136 / 349	264 / 349

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

ResultKopple JD, Cheung AK, Christiansen JS, Djurhuus CB, El Nahas M, Feldt-Rasmussen B, Lange M, Mitch WE, Wanner C, Wiedemann J, Ikizler TA. OPPORTUNITY: a randomized clinical trial of growth hormone on outcome in hemodialysis patients. Clin J Am Soc Nephrol. 2008 Nov;3(6):1741-51. doi: 10.2215/CJN.02760608. PMID 18945992
ResultRaff AC, Meyer TW, Hostetter TH. New insights into uremic toxicity. Curr Opin Nephrol Hypertens. 2008 Nov;17(6):560-5. doi: 10.1097/MNH.0b013e32830f45b6. PMID 18941347

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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)

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