The Effect of Somatropin Treatment in Adult Patients on Chronic Dialysis

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Chronic Kidney Disease, End-Stage Renal Disease

In brief

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.

Key facts

Study ID

NCT00503698

Run by

Novo Nordisk A/S

People needed

712

Starts

2007-07-01

Expected to finish

2008-12-01

Last updated by the study team

2017-03-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Novo Nordisk Investigational Site — Birmingham, Alabama, United States
• Novo Nordisk Investigational Site — Madison, Alabama, United States
• Novo Nordisk Investigational Site — Mobile, Alabama, United States
• Novo Nordisk Investigational Site — Mobile, Alabama, United States
• Novo Nordisk Investigational Site — Montgomery, Alabama, United States
• Novo Nordisk Investigational Site — Glendale, Arizona, United States
• Novo Nordisk Investigational Site — Phoenix, Arizona, United States
• Novo Nordisk Investigational Site — Tempe, Arizona, United States
• Novo Nordisk Investigational Site — Tucson, Arizona, United States
• Novo Nordisk Investigational Site — Tuscon, Arizona, United States
• Novo Nordisk Investigational Site — El Dorado, Arkansas, United States
• Novo Nordisk Investigational Site — Fort Smith, Arkansas, United States
• Novo Nordisk Investigational Site — Hot Springs, Arkansas, United States
• Novo Nordisk Investigational Site — Little Rock, Arkansas, United States
• Novo Nordisk Investigational Site — McGehee, Arkansas, United States
• Novo Nordisk Investigational Site — Paragould, Arkansas, United States
• Novo Nordisk Investigational Site — Pine Bluff, Arkansas, United States
• Novo Nordisk Investigational Site — Beverly Hills, California, United States
• Novo Nordisk Investigational Site — Chula Vista, California, United States
• Novo Nordisk Investigational Site — Covina, California, United States
• Novo Nordisk Investigational Site — Escondido, California, United States
• Novo Nordisk Investigational Site — Glendale, California, United States
• Novo Nordisk Investigational Site — La Mesa, California, United States
• Novo Nordisk Investigational Site — Lakewood, California, United States
• Novo Nordisk Investigational Site — Alexander City, Alabama, United States

Full record on ClinicalTrials.gov

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