The Effect of Somatropin Treatment in Adult Patients on Chronic Dialysis

Last updated: January 23, 2017
Sponsor: Novo Nordisk A/S
Overall Status: Terminated

Phase

3

Condition

Nephropathy

Renal Failure

Focal Segmental Glomerulosclerosis

Treatment

N/A

Clinical Study ID

NCT00503698
NN1630-1453
2006-004702-56
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 priorto enrolment as defined by Kt/V of more than 1.2

Exclusion

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 ofthe investigator

  • Severe illness as defined in the protocol (as judged by the investigator)

Study Design

Total Participants: 712
Study Start date:
July 01, 2007
Estimated Completion Date:
December 31, 2008

Study 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.

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    Buenos Aires, C1181ACH
    Argentina

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    Capital Federal, C1431FWO
    Argentina

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    Cordoba, X5002HWE
    Argentina

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    Morón, B1708DPO
    Argentina

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    Morón, B1708DPO
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    Pergamino, B2700CPM
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    San Miguel de Tucuman, 4000
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    Sarandí, B1872EEA
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    Temperley, 1834
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  • Novo Nordisk Investigational Site

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Shreveport, Louisiana 71101
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Bethesda, Maryland 20814
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Easton, Maryland 21601
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Rockville, Maryland 20852
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Silver Spring, Maryland 20906
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Brockton, Massachusetts 02301
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Jamaica Plain, Massachusetts 02130
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Springfield, Massachusetts 01107
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dearborn, Michigan 48126
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Detroit, Michigan 48236
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kalamazoo, Michigan 49007
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lansing, Michigan 48912
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Columbus, Mississippi 39705
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Gulfport, Mississippi 39501
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    St. Ann, Missouri 63074
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    St. Louis, Missouri 63103
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    St. Peters, Missouri 63376
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Billings, Montana 59101
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kearney, Nebraska 68848
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    North Platte, Nebraska 69101
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Eatontown, New Jersey 07724
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Livingston, New Jersey 07039
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Voorhees, New Jersey 08043
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Albuquerque, New Mexico 87106
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Bronx, New York 10461
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Brooklyn, New York 11226
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Buffalo, New York 14209
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Cooperstown, New York 13326
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fresh Meadows, New York 11365
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Mineola, New York 11501
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    New York, New York 10025
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Port Washington, New York 11050
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Rochester, New York 14621
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Rosedale, New York 11422
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Yonkers, New York 10704
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hamlet, North Carolina 28345
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Winston-Salem, North Carolina 27101
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dayton, Ohio 45428
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Toledo, Ohio 43606
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Xenia, Ohio 45385
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Bend, Oregon 97701
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Medford, Oregon 97504
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Portland, Oregon 97210
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Roseburg, Oregon 97471
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Allentown, Pennsylvania 18103
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Erie, Pennsylvania 16507
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Johnstown, Pennsylvania 15905
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lewistown, Pennsylvania 17044
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Meadville, Pennsylvania 16335
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Pittsburg, Pennsylvania 15240
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Providence, Rhode Island 02904
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Columbia, South Carolina 29209
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Orangeburg, South Carolina 29115
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Santee, South Carolina 29142
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Sumter, South Carolina 29150
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Clarksville, Tennessee 37043
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dyersburg, Tennessee 38024
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Johnson City, Tennessee 37604
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Nashville, Tennessee 37205-1492
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Arlington, Texas 76105
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Corpus Christi, Texas 78411
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dallas, Texas 75235
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Houston, Texas 77099
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Killeen, Texas 76543
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lubbock, Texas 79430
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    McAllen, Texas 78503
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Antonio, Texas 78207
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Tyler, Texas 75701
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Weslaco, Texas 78596
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Provo, Utah 84604
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Burlington, Vermont 05401
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Alexandria, Virginia 22304
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Charlottesville, Virginia 22902
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chesapeake, Virginia 23320
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fairfax, Virginia 22030
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hampton, Virginia 23667
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Mechanicsville, Virginia 23116
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Portsmouth, Virginia 23704
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Salem, Virginia 24153
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Seattle, Washington 98133
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Bluefield, West Virginia 24701
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Glendale, Wisconsin 53209
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Marshfield, Wisconsin 54449
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Milwaukee, Wisconsin 53295
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Neenah, Wisconsin 54956
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Oshkosh, Wisconsin 54904
    United States

    Site Not Available

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