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 long standing haemodialysis.

Outcome Trial Evaluating the Efficacy and Safety of Norditropin in Adult Patients on Chronic Haemodialysis. A Randomised, Double-blind, Parallel group, Placebo controlled, Multi-centre trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/02/002443

Enrollment

715

Registered

2012-02-24

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N17-N19- Acute kidney failure and chronic kidney disease Health Condition 2: null- End-Stage Renal Disease (ESRD)

Interventions

Intervention1: somatropin: 20 mcg/kg/day, injected s.c. (under the skin) once daily from week 0 to end of trial Control Intervention1: placebo: Placebo injected s.c (under the skin) / day to the end o

Eligibility

Inclusion 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 -Upper limit of age not mentioned

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Mortality - Time to All-cause DeathTimepoint: week 0 and study termination	—

Secondary

Measure	Time frame
Health Related Quality of Life AssessmentsTimepoint: week 0 and study termination ;Morbidity - Number of Hospitalisations, in Addition to Normal Dialysis ProceduresTimepoint: week 0 and study termination;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)Timepoint: week 0 and study termination;Mortality - Two-year Mortality RateTimepoint: week 0 and study termination	—

Measure

Time frame

Health Related Quality of Life AssessmentsTimepoint: week 0 and study termination ;Morbidity - Number of Hospitalisations, in Addition to Normal Dialysis ProceduresTimepoint: week 0 and study termination;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)Timepoint: week 0 and study termination;Mortality - Two-year Mortality RateTimepoint: week 0 and study termination

—

Countries

Argentina, Brazil, Canada, Denmark, France, Germany, Hungary, Israel, Italy, Poland, Portugal, Russian Federation, South Africa, Spain, Sweden, Turkey, United Kingdom, United States of America

Contacts

Public ContactAvik Kumar Ghosh

Novonordisk India Private Limited

rasy@novonordisk.com918030713358

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026