Efficacy and Safety of Somatropin in Adult Patients on Chronic Haemodialysis

TerminadoFase 3ClinicalTrials.gov

ID: NCT00503698Tipo: INTERVENTIONALInicio: 1 de jul de 2007Fin estimado: 1 de dic de 2008

Traducción no disponible, mostrando original

Resumen

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.

Descripción detallada

The decision to discontinue the trial is not due to safety concerns. The discontinuation is based on an analysis of the significant delay in recruitment of patients which is expected to have a negative impact on the outcome of the trial.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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)

Intervenciones

drug

somatropin

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

drug

placebo

Placebo injected s.c (under the skin)

Ubicaciones

Novo Nordisk Investigational Site

Buenos Aires, Argentina

Novo Nordisk Investigational Site

Buenos Aires, Argentina

Novo Nordisk Investigational Site

Capital Federal, Argentina

Novo Nordisk Investigational Site

Capital Federal, Argentina

Novo Nordisk Investigational Site

Córdoba, Argentina

Novo Nordisk Investigational Site

Morón, Argentina

Novo Nordisk Investigational Site

Pergamino, Argentina

Novo Nordisk Investigational Site

San Miguel de Tucumán, Argentina

Novo Nordisk Investigational Site

Sarandí, Argentina

Novo Nordisk Investigational Site

Temperley, Argentina

Patrocinadores

PrincipalNovo Nordisk A/S

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