Brief 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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

712

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Jul 2007

Geographic Reach

21 countries

381 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.4 years study duration

Study Start

First participant enrolled

July 1, 2007

Completed

17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2007

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed

1.6 years until next milestone

Results Posted

Study results publicly available

July 13, 2010

Completed

Last Updated

March 7, 2017

Status Verified

January 1, 2017

Enrollment Period

1.4 years

First QC Date

July 18, 2007

Results QC Date

December 15, 2009

Last Update Submit

January 23, 2017

Conditions

Chronic Kidney Disease End-Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

Mortality - Time to All-cause Death
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.
week 0, trial termination

Secondary Outcomes (4)

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)
week 0, trial termination
Morbidity - Number of Hospitalisations, in Addition to Normal Dialysis Procedures
week 0, trial termination
Mortality - Two-year Mortality Rate
week 0, trial termination
Health Related Quality of Life Assessments
week 0, trial termination

Study Arms (2)

Somatropin

EXPERIMENTAL

Somatropin once daily from week 0 to end of trial

Drug: somatropin

Placebo

PLACEBO COMPARATOR

Placebo once daily to end of trial

Drug: placebo

Interventions

somatropinDRUG

20 mcg/kg/day, injected s.c. (under the skin)

Somatropin

placeboDRUG

Placebo injected s.c (under the skin)

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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)

Contact the study team to confirm eligibility.