The Effect of Somatropin Treatment in Adult Patients on Chronic Dialysis

• Status: Terminated
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S

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)