The Effect of Somatropin Treatment in Adult Patients on Chronic Dialysis

Chronic Kidney Disease Clinical Trial

— OPPORTUNITY  

Official title:

Efficacy and Safety of Somatropin in Adult Patients on Chronic Haemodialysis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00503698
• Other study ID #: NN1630-1453
• Secondary ID: 2006-004702-56
• Status: Terminated
• Phase: Phase 3
• First received: July 18, 2007
• Last updated: October 28, 2014
• Start date: July 2007
• Est. completion date: December 2008

Study information

• Verified date: October 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products RegulatoryFrance: Agence du MédicamentGermany: Federal Institute for Drugs and Medical DevicesItaly: The Italian Medicines AgencySpain: Spanish Drug Agency and Medicinal ProductsPoland: National Medicines InstitutePortugal: INFARMEDDenmark: Danish Medicines AgencySweden: Medical Products AgencyArgentina: Administracion Nacional de Medicamentos, Alimentos y TecnologiaBrazil: National Health Surveillance AgencyIsrael: Israeli Health Ministry Pharmaceutical AdministrationSouth Africa: Medicines Control CouncilTurkey: Ministry of Health Drug and Pharmaceutical DepartmentRussia: Federal Service for Control of Health Care and Social DevelopmentCanada: Health CanadaHungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 712
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• End-Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Drug:
• somatropin
20 mcg/kg/day, injected s.c. (under the skin)
• placebo
Placebo injected s.c (under the skin)

Locations

Country	Name	City	State
Puerto Rico	Novo Nordisk Clinical Trial Call Center	Ponce
United States	Novo Nordisk Clinical Trial Call Center	Alexander City	Alabama
United States	Novo Nordisk Clinical Trial Call Center	Alexandria	Virginia
United States	Novo Nordisk Clinical Trial Call Center	Allentown	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Arlington	Texas
United States	Novo Nordisk Clinical Trial Call Center	Atlanta	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Augusta	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Baton Rouge	Louisiana
United States	Novo Nordisk Clinical Trial Call Center	Bend	Oregon
United States	Novo Nordisk Clinical Trial Call Center	Bethesda	Maryland
United States	Novo Nordisk Clinical Trial Call Center	Beverly Hills	California
United States	Novo Nordisk Clinical Trial Call Center	Billings	Montana
United States	Novo Nordisk Clinical Trial Call Center	Birmingham	Alabama
United States	Novo Nordisk Clinical Trial Call Center	Bluefield	West Virginia
United States	Novo Nordisk Clinical Trial Call Center	Boise	Idaho
United States	Novo Nordisk Clinical Trial Call Center	Boston	Massachusetts
United States	Novo Nordisk Clinical Trial Call Center	Brandon	Florida
United States	Novo Nordisk Clinical Trial Call Center	Brockton	Massachusetts
United States	Novo Nordisk Clinical Trial Call Center	Bronx	New York
United States	Novo Nordisk Clinical Trial Call Center	Bronx	New York
United States	Novo Nordisk Clinical Trial Call Center	Brooklyn	New York
United States	Novo Nordisk Clinical Trial Call Center	Buffalo	New York
United States	Novo Nordisk Clinical Trial Call Center	Buffalo	New York
United States	Novo Nordisk Clinical Trial Call Center	Burlington	Vermont
United States	Novo Nordisk Clinical Trial Call Center	Chesapeake	Virginia
United States	Novo Nordisk Clinical Trial Call Center	Chula Vista	California
United States	Novo Nordisk Clinical Trial Call Center	Clarksville	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	Colorado Springs	Colorado
United States	Novo Nordisk Clinical Trial Call Center	Columbus	Mississippi
United States	Novo Nordisk Clinical Trial Call Center	Columbus	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Cooperstown	New York
United States	Novo Nordisk Clinical Trial Call Center	Coral Springs	Florida
United States	Novo Nordisk Clinical Trial Call Center	Corpus Christi	Texas
United States	Novo Nordisk Clinical Trial Call Center	Corpus Christi	Texas
United States	Novo Nordisk Clinical Trial Call Center	Covina	California
United States	Novo Nordisk Clinical Trial Call Center	Crestwood	Illinois
United States	Novo Nordisk Clinical Trial Call Center	Dallas	Texas
United States	Novo Nordisk Clinical Trial Call Center	Denver	Colorado
United States	Novo Nordisk Clinical Trial Call Center	Des Moines	Iowa
United States	Novo Nordisk Clinical Trial Call Center	Detroit	Michigan
United States	Novo Nordisk Clinical Trial Call Center	Durham	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	Dyersburg	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	Easton	Maryland
United States	Novo Nordisk Clinical Trial Call Center	Eatontown	New Jersey
United States	Novo Nordisk Clinical Trial Call Center	Eldorado	Arkansas
United States	Novo Nordisk Clinical Trial Call Center	Evergreen Park	Illinois
United States	Novo Nordisk Clinical Trial Call Center	Fairfax	Virginia
United States	Novo Nordisk Clinical Trial Call Center	Fresh Meadows	New York
United States	Novo Nordisk Clinical Trial Call Center	Glendale	Wisconsin
United States	Novo Nordisk Clinical Trial Call Center	Glendale	Arizona
United States	Novo Nordisk Clinical Trial Call Center	Glendale	California
United States	Novo Nordisk Clinical Trial Call Center	Greenville	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	Gulfport	Mississippi
United States	Novo Nordisk Clinical Trial Call Center	Gurnee	Illinois
United States	Novo Nordisk Clinical Trial Call Center	Hagerstown	Maryland
United States	Novo Nordisk Clinical Trial Call Center	Hampton	Virginia
United States	Novo Nordisk Clinical Trial Call Center	Hot Springs	Arkansas
United States	Novo Nordisk Clinical Trial Call Center	Houston	Texas
United States	Novo Nordisk Clinical Trial Call Center	Indianapolis	Indiana
United States	Novo Nordisk Clinical Trial Call Center	Jackson	Mississippi
United States	Novo Nordisk Clinical Trial Call Center	Johnstown	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Kalamazoo	Michigan
United States	Novo Nordisk Clinical Trial Call Center	Kearney	Nebraska
United States	Novo Nordisk Clinical Trial Call Center	Killeen	Texas
United States	Novo Nordisk Clinical Trial Call Center	Knoxville	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	Knoxville	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	La Mesa	California
United States	Novo Nordisk Clinical Trial Call Center	Lafayatte	Louisiana
United States	Novo Nordisk Clinical Trial Call Center	Lakewood	California
United States	Novo Nordisk Clinical Trial Call Center	Lewistown	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Lexington	Kentucky
United States	Novo Nordisk Clinical Trial Call Center	Los Alamitos	California
United States	Novo Nordisk Clinical Trial Call Center	Los Angeles	California
United States	Novo Nordisk Clinical Trial Call Center	Lubbock	Texas
United States	Novo Nordisk Clinical Trial Call Center	Lynwood	California
United States	Novo Nordisk Clinical Trial Call Center	Macon	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Madisonville	Kentucky
United States	Novo Nordisk Clinical Trial Call Center	Marietta	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Maywood	Illinois
United States	Novo Nordisk Clinical Trial Call Center	McGehee	Arkansas
United States	Novo Nordisk Clinical Trial Call Center	Meadville	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Medford	Oregon
United States	Novo Nordisk Clinical Trial Call Center	Merced	California
United States	Novo Nordisk Clinical Trial Call Center	Meridian	Idaho
United States	Novo Nordisk Clinical Trial Call Center	Miami	Florida
United States	Novo Nordisk Clinical Trial Call Center	Michigan City	Indiana
United States	Novo Nordisk Clinical Trial Call Center	Middlebury	Connecticut
United States	Novo Nordisk Clinical Trial Call Center	Milwaukee	Wisconsin
United States	Novo Nordisk Clinical Trial Call Center	Mission Hills	California
United States	Novo Nordisk Clinical Trial Call Center	Mobile	Alabama
United States	Novo Nordisk Clinical Trial Call Center	Mobile	Alabama
United States	Novo Nordisk Clinical Trial Call Center	Monterey Park	California
United States	Novo Nordisk Clinical Trial Call Center	Mountain View	California
United States	Novo Nordisk Clinical Trial Call Center	Nashville	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	Nashville	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	Nashville	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	Neenah	Wisconsin
United States	Novo Nordisk Clinical Trial Call Center	New Iberia	Louisiana
United States	Novo Nordisk Clinical Trial Call Center	New York	New York
United States	Novo Nordisk Clinical Trial Call Center	New York	New York
United States	Novo Nordisk Clinical Trial Call Center	New York	New York
United States	Novo Nordisk Clinical Trial Call Center	Norfolk	Virginia
United States	Novo Nordisk Clinical Trial Call Center	North Charleston	South Carolina
United States	Novo Nordisk Clinical Trial Call Center	North Platte	Nebraska
United States	Novo Nordisk Clinical Trial Call Center	Orangeburg	South Carolina
United States	Novo Nordisk Clinical Trial Call Center	Orlando	Florida
United States	Novo Nordisk Clinical Trial Call Center	Oshkosh	Wisconsin
United States	Novo Nordisk Clinical Trial Call Center	Panama City	Florida
United States	Novo Nordisk Clinical Trial Call Center	Paragould	Arkansas
United States	Novo Nordisk Clinical Trial Call Center	Pembroke Pines	Florida
United States	Novo Nordisk Clinical Trial Call Center	Philadelphia	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Philadelphia	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Phoenix	Arizona
United States	Novo Nordisk Clinical Trial Call Center	Pine Bluff	Arkansas
United States	Novo Nordisk Clinical Trial Call Center	Pittsburg	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Pittsburgh	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Port Washington	New York
United States	Novo Nordisk Clinical Trial Call Center	Porterville	California
United States	Novo Nordisk Clinical Trial Call Center	Portsmouth	Virginia
United States	Novo Nordisk Clinical Trial Call Center	Provo	Utah
United States	Novo Nordisk Clinical Trial Call Center	Riverside	California
United States	Novo Nordisk Clinical Trial Call Center	Rockville	Maryland
United States	Novo Nordisk Clinical Trial Call Center	Roseburg	Oregon
United States	Novo Nordisk Clinical Trial Call Center	Sacramento	California
United States	Novo Nordisk Clinical Trial Call Center	Salem	Virginia
United States	Novo Nordisk Clinical Trial Call Center	San Antonio	Texas
United States	Novo Nordisk Clinical Trial Call Center	San Antonio	Texas
United States	Novo Nordisk Clinical Trial Call Center	Santee	South Carolina
United States	Novo Nordisk Clinical Trial Call Center	Shreveport	Louisiana
United States	Novo Nordisk Clinical Trial Call Center	Springfield	Massachusetts
United States	Novo Nordisk Clinical Trial Call Center	St. Ann	Missouri
United States	Novo Nordisk Clinical Trial Call Center	St. Louis	Missouri
United States	Novo Nordisk Clinical Trial Call Center	St. Louis	Missouri
United States	Novo Nordisk Clinical Trial Call Center	St. Peters	Missouri
United States	Novo Nordisk Clinical Trial Call Center	Sumter	South Carolina
United States	Novo Nordisk Clinical Trial Call Center	Tampa	Florida
United States	Novo Nordisk Clinical Trial Call Center	Tampa	Florida
United States	Novo Nordisk Clinical Trial Call Center	Tempe	Arizona
United States	Novo Nordisk Clinical Trial Call Center	Toledo	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Topeka	Kansas
United States	Novo Nordisk Clinical Trial Call Center	Torrance	California
United States	Novo Nordisk Clinical Trial Call Center	Tucson	Arizona
United States	Novo Nordisk Clinical Trial Call Center	Tuscon	Arizona
United States	Novo Nordisk Clinical Trial Call Center	Tyler	Texas
United States	Novo Nordisk Clinical Trial Call Center	Vacaville	California
United States	Novo Nordisk Clinical Trial Call Center	Visalia	California
United States	Novo Nordisk Clinical Trial Call Center	Voorhees	New Jersey
United States	Novo Nordisk Clinical Trial Call Center	Walnut Creek	California
United States	Novo Nordisk Clinical Trial Call Center	Washington	District of Columbia
United States	Novo Nordisk Clinical Trial Call Center	Weston	Florida
United States	Novo Nordisk Clinical Trial Call Center	Whittier	California
United States	Novo Nordisk Clinical Trial Call Center	Whittier	California
United States	Novo Nordisk Clinical Trial Call Center	Wichita	Kansas
United States	Novo Nordisk Clinical Trial Call Center	Yonkers	New York
United States	Novo Nordisk Clinical Trial Call Center	Yuba City	California

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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)	Morbidity - time from week 0 to next cardiovascular event (composite of all-cause mortality and cardiovascular events defined as adjudicated medical event of special interest and categorised as myocardial infarctions, cardiac insufficiencies, strokes or other thrombo-embolic events). Statistical analysis is based on all available information from week 0 to trial termination. Summary data illustrates percentage (%) participants with events estimated using Kaplan-Meier. Summary data illustrates morbidity until 52 weeks, because very few subjects had trial time longer than 52 weeks.	week 0, trial termination	Yes
Secondary	Morbidity - Number of Hospitalisations, in Addition to Normal Dialysis Procedures	The number of times that the patient was hospitalised in addition to hospitalisation for normal dialysis procedures measured from week 0 (randomisation) to the time the trial was terminated.	week 0, trial termination	No
Secondary	Mortality - Two-year Mortality Rate		week 0, trial termination	No
Secondary	Health Related Quality of Life Assessments	Summary from activity of daily living from the Rotterdam Symptom Checklist (RSCL) measuring activity from 1 (active) to 5 (inactive). The Edmonton Symptom Assessment System (ESAS), subjects assess their health in the last 24 hours on a scale from 1 (good health) to 3 (feeling poorly). The EQ-5D is a measure of subjects' health outcome from 0 (death) to 1 (full health). SF-36 (Short Form (36)) covering mental and physicial health is provided in a scale from 0-100 with higher scores indicating greater satisfaction.	week 0, trial termination	No

External Links

•   Clinical Trials at Novo Nordisk