The Effect of Somatropin Treatment in Adult Patients on Chronic Dialysis
NCT ID: NCT00503698
Last Updated: 2017-03-07
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
712 participants
INTERVENTIONAL
2007-07-31
2008-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Somatropin
Somatropin once daily from week 0 to end of trial
somatropin
20 mcg/kg/day, injected s.c. (under the skin)
Placebo
Placebo once daily to end of trial
placebo
Placebo injected s.c (under the skin)
Interventions
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somatropin
20 mcg/kg/day, injected s.c. (under the skin)
placebo
Placebo injected s.c (under the skin)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Alexander City, Alabama, United States
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Birmingham, Alabama, United States
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References
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Kopple 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.
Raff 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.
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Clinical Trials at Novo Nordisk
Other Identifiers
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2006-004702-56
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN1630-1453
Identifier Type: -
Identifier Source: org_study_id
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