The Effect of Somatropin Treatment in Adult Patients on Chronic Dialysis (OPPORTUNITY)

This study has been terminated.
(See termination reason in detailed description)
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00503698
First received: July 18, 2007
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
End-Stage Renal Disease
Drug: somatropin
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Somatropin in Adult Patients on Chronic Haemodialysis

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Mortality - Time to All-cause Death [ Time Frame: week 0, trial termination ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Health Related Quality of Life Assessments [ Time Frame: week 0, trial termination ] [ Designated as safety issue: No ]
    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.


Enrollment: 712
Study Start Date: July 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Somatropin
Somatropin once daily from week 0 to end of trial
Drug: somatropin
20 mcg/kg/day, injected s.c. (under the skin)
Placebo Comparator: Placebo
Placebo once daily to end of trial
Drug: placebo
Placebo injected s.c (under the skin)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503698

  Show 172 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00503698     History of Changes
Other Study ID Numbers: NN1630-1453, 2006-004702-56
Study First Received: July 18, 2007
Results First Received: December 15, 2009
Last Updated: June 24, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory
France: Agence du Médicament
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Spain: Spanish Drug Agency and Medicinal Products
Poland: National Medicines Institute
Portugal: INFARMED
Denmark: Danish Medicines Agency
Sweden: Medical Products Agency
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia
Brazil: National Health Surveillance Agency
Israel: Israeli Health Ministry Pharmaceutical Administration
South Africa: Medicines Control Council
Turkey: Ministry of Health Drug and Pharmaceutical Department
Russia: Federal Service for Control of Health Care and Social Development
Canada: Health Canada
Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on July 23, 2014