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

This study has been terminated.
(See termination reason in detailed description)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00503698
First Posted: July 19, 2007
Last Update Posted: March 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    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 ]
    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.


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00503698


  Show 381 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:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00503698     History of Changes
Other Study ID Numbers: NN1630-1453
2006-004702-56 ( EudraCT Number )
First Submitted: July 18, 2007
First Posted: July 19, 2007
Results First Submitted: December 15, 2009
Results First Posted: July 13, 2010
Last Update Posted: March 7, 2017
Last Verified: January 2017

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