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TERMINATEDPhase 3NCT00503698

The Effect of Somatropin Treatment in Adult Patients on Chronic Dialysis

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-poin...

Lead sponsor: Novo Nordisk A/S•209 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Novo Nordisk A/S

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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)

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 7, 2017Terms

Trial snapshot

StatusTERMINATED

PhasePHASE3

Enrollment712

Start dateJul 2007

Last updatedMar 7, 2017

Condition

Chronic Kidney Disease End-Stage Renal Disease

Locations shown

Novo Nordisk Investigational Site

Alexander City, Alabama

Novo Nordisk Investigational Site

Birmingham, Alabama

Novo Nordisk Investigational Site

Madison, Alabama

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 7, 2017Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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