AzTrials
AzTrials

Chronic Kidney DiseasePhase 3OPPORTUNITYNCT00503698

The Effect of Somatropin Treatment in Adult Patients on Chronic Dialysis

A Phase 3 study testing somatropin in people with Chronic Kidney Disease and End-Stage Renal Disease, run by Novo Nordisk A/S at 381 sites in 21 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
somatropin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
712 participants
Where
381 sitesin 21 countries
Study dates
Jul 2007to Dec 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

381 sites in 21 countries.

381 sites in 21 countries

United States209 sites

  • Novo Nordisk Investigational Site

    Albuquerque, New Mexico, 87106

  • Novo Nordisk Investigational Site

    Alexander City, Alabama, 35010

  • Novo Nordisk Investigational Site

    Alexandria, Virginia, 22304

  • Novo Nordisk Investigational Site

    Allentown, Pennsylvania, 18103

  • Novo Nordisk Investigational Site

    Arlington, Texas, 76105

  • Novo Nordisk Investigational Site

    Atlanta, Georgia, 30329

  • Novo Nordisk Investigational Site

    Atlanta, Georgia, 30331

  • Novo Nordisk Investigational Site

    Atlantis, Florida, 33462

  • Novo Nordisk Investigational Site

    Augusta, Georgia, 30901

  • Novo Nordisk Investigational Site

    Augusta, Georgia, 30912-3260

  • Novo Nordisk Investigational Site

    Baton Rouge, Louisiana, 70809

  • Novo Nordisk Investigational Site

    Bend, Oregon, 97701

  • Novo Nordisk Investigational Site

    Bethesda, Maryland, 20814

  • Novo Nordisk Investigational Site

    Beverly Hills, California, 90211

  • Novo Nordisk Investigational Site

    Billings, Montana, 59101

  • Novo Nordisk Investigational Site

    Birmingham, Alabama, 35211

  • Novo Nordisk Investigational Site

    Bluefield, West Virginia, 24701

  • Novo Nordisk Investigational Site

    Boise, Idaho, 83706

  • Novo Nordisk Investigational Site

    Boston, Massachusetts, 02215

  • Novo Nordisk Investigational Site

    Brandon, Florida, 33511

  • Novo Nordisk Investigational Site

    Brockton, Massachusetts, 02301

  • Novo Nordisk Investigational Site

    Brooklyn, New York, 11212

  • Novo Nordisk Investigational Site

    Brooklyn, New York, 11226

  • Novo Nordisk Investigational Site

    Buffalo, New York, 14086

  • Novo Nordisk Investigational Site

    Buffalo, New York, 14209

  • Novo Nordisk Investigational Site

    Burlington, Vermont, 05401

  • Novo Nordisk Investigational Site

    Charleston, South Carolina, 29425

  • Novo Nordisk Investigational Site

    Charlottesville, Virginia, 22902

  • Novo Nordisk Investigational Site

    Chesapeake, Virginia, 23320

  • Novo Nordisk Investigational Site

    Chula Vista, California, 91910

  • Novo Nordisk Investigational Site

    City of Saint Peters, Missouri, 63376

  • Novo Nordisk Investigational Site

    Clarksville, Tennessee, 37043

  • Novo Nordisk Investigational Site

    Cleveland, Ohio, 44109

  • Novo Nordisk Investigational Site

    Colorado Springs, Colorado, 80909

  • Novo Nordisk Investigational Site

    Columbia, South Carolina, 29209

  • Novo Nordisk Investigational Site

    Columbus, Mississippi, 39705

  • Novo Nordisk Investigational Site

    Columbus, Ohio, 43210

  • Novo Nordisk Investigational Site

    Cooperstown, New York, 13326

  • Novo Nordisk Investigational Site

    Coral Springs, Florida, 33071

  • Novo Nordisk Investigational Site

    Corpus Christi, Texas, 78404

  • Novo Nordisk Investigational Site

    Corpus Christi, Texas, 78411

  • Novo Nordisk Investigational Site

    Covina, California, 91723

  • Novo Nordisk Investigational Site

    Crestwood, Illinois, 60445

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75235

  • Novo Nordisk Investigational Site

    Dallas, Texas, 78216

  • Novo Nordisk Investigational Site

    Dayton, Ohio, 45428

  • Novo Nordisk Investigational Site

    Dearborn, Michigan, 48126

  • Novo Nordisk Investigational Site

    Denver, Colorado, 80220

  • Novo Nordisk Investigational Site

    Des Moines, Iowa, 50309

  • Novo Nordisk Investigational Site

    Detroit, Michigan, 48202

  • Novo Nordisk Investigational Site

    Detroit, Michigan, 48236

  • Novo Nordisk Investigational Site

    Durham, North Carolina, 27710

  • Novo Nordisk Investigational Site

    Dyersburg, Tennessee, 38024

  • Novo Nordisk Investigational Site

    Easton, Maryland, 21601

  • Novo Nordisk Investigational Site

    Eatontown, New Jersey, 07724

  • Novo Nordisk Investigational Site

    El Dorado, Arkansas, 71730

  • Novo Nordisk Investigational Site

    Escondido, California, 92025

  • Novo Nordisk Investigational Site

    Evansville, Indiana, 47714

  • Novo Nordisk Investigational Site

    Evergreen Park, Illinois, 60805

  • Novo Nordisk Investigational Site

    Fairfax, Virginia, 22030

  • Novo Nordisk Investigational Site

    Fort Smith, Arkansas, 72901

  • Novo Nordisk Investigational Site

    Fresh Meadows, New York, 11365

  • Novo Nordisk Investigational Site

    Glendale, Arizona, 85306

  • Novo Nordisk Investigational Site

    Glendale, California, 91205

  • Novo Nordisk Investigational Site

    Glendale, Wisconsin, 53209

  • Novo Nordisk Investigational Site

    Greenville, North Carolina, 27834

  • Novo Nordisk Investigational Site

    Gulfport, Mississippi, 39501

  • Novo Nordisk Investigational Site

    Gurnee, Illinois, 60031

  • Novo Nordisk Investigational Site

    Hagerstown, Maryland, 21740

  • Novo Nordisk Investigational Site

    Hamlet, North Carolina, 28345

  • Novo Nordisk Investigational Site

    Hampton, Virginia, 23667

  • Novo Nordisk Investigational Site

    Hot Springs, Arkansas, 71901

  • Novo Nordisk Investigational Site

    Houston, Texas, 77003

  • Novo Nordisk Investigational Site

    Houston, Texas, 77004

  • Novo Nordisk Investigational Site

    Houston, Texas, 77030

  • Novo Nordisk Investigational Site

    Houston, Texas, 77099

  • Novo Nordisk Investigational Site

    Indianapolis, Indiana, 46202

  • Novo Nordisk Investigational Site

    Jackson, Mississippi, 39216

  • Novo Nordisk Investigational Site

    Jacksonville, Florida, 32224

  • Novo Nordisk Investigational Site

    Johnstown, Pennsylvania, 15905

  • Novo Nordisk Investigational Site

    Kalamazoo, Michigan, 49007

  • Novo Nordisk Investigational Site

    Kansas City, Kansas, 66160

  • Novo Nordisk Investigational Site

    Kearney, Nebraska, 68848

  • Novo Nordisk Investigational Site

    Killeen, Texas, 76543

  • Novo Nordisk Investigational Site

    Knoxville, Tennessee, 37920

  • Novo Nordisk Investigational Site

    Knoxville, Tennessee, 37923

  • Novo Nordisk Investigational Site

    La Mesa, California, 91942

  • Novo Nordisk Investigational Site

    Lafayatte, Louisiana, 70506

  • Novo Nordisk Investigational Site

    Lakewood, California, 90712

  • Novo Nordisk Investigational Site

    Lakewood, Colorado, 80214

  • Novo Nordisk Investigational Site

    Lansing, Michigan, 48912

  • Novo Nordisk Investigational Site

    Lewistown, Pennsylvania, 17044

  • Novo Nordisk Investigational Site

    Lexington, Kentucky, 40513

  • Novo Nordisk Investigational Site

    Little Rock, Arkansas, 72204

  • Novo Nordisk Investigational Site

    Livingston, New Jersey, 07039

  • Novo Nordisk Investigational Site

    Long Beach, California, 90822

  • Novo Nordisk Investigational Site

    Los Alamitos, California, 90720

  • Novo Nordisk Investigational Site

    Los Angeles, California, 90017

  • Novo Nordisk Investigational Site

    Los Angeles, California, 90033

  • Novo Nordisk Investigational Site

    Los Angeles, California, 90095

  • Novo Nordisk Investigational Site

    Lubbock, Texas, 79430

  • Novo Nordisk Investigational Site

    Lynwood, California, 90262

  • Novo Nordisk Investigational Site

    Macon, Georgia, 31217

  • Novo Nordisk Investigational Site

    Madison, Alabama, 35758

  • Novo Nordisk Investigational Site

    Madisonville, Kentucky, 42431

  • Novo Nordisk Investigational Site

    Marietta, Georgia, 30066

  • Novo Nordisk Investigational Site

    Marshfield, Wisconsin, 54449

  • Novo Nordisk Investigational Site

    Maywood, Illinois, 60153

  • Novo Nordisk Investigational Site

    McAllen, Texas, 78503

  • Novo Nordisk Investigational Site

    McGehee, Arkansas, 71654

  • Novo Nordisk Investigational Site

    Meadville, Pennsylvania, 16335

  • Novo Nordisk Investigational Site

    Mechanicsville, Virginia, 23116

  • Novo Nordisk Investigational Site

    Medford, Oregon, 97504

  • Novo Nordisk Investigational Site

    Merced, California, 95340

  • Novo Nordisk Investigational Site

    Meridian, Idaho, 83642

  • Novo Nordisk Investigational Site

    Miami, Florida, 33173

  • Novo Nordisk Investigational Site

    Michigan City, Indiana, 46360

  • Novo Nordisk Investigational Site

    Middlebury, Connecticut, 06762

  • Novo Nordisk Investigational Site

    Milwaukee, Wisconsin, 53295

  • Novo Nordisk Investigational Site

    Mineola, New York, 11501

  • Novo Nordisk Investigational Site

    Minneapolis, Minnesota, 55404

  • Novo Nordisk Investigational Site

    Mission Hills, California, 91345

  • Novo Nordisk Investigational Site

    Mobile, Alabama, 36608

  • Novo Nordisk Investigational Site

    Mobile, Alabama, 36617

  • Novo Nordisk Investigational Site

    Monterey Park, California, 91745

  • Novo Nordisk Investigational Site

    Montgomery, Alabama, 36106

  • Novo Nordisk Investigational Site

    Mountain View, California, 94041

  • Novo Nordisk Investigational Site

    Naples, Florida, 34119

  • Novo Nordisk Investigational Site

    Nashville, Tennessee, 37203

  • Novo Nordisk Investigational Site

    Nashville, Tennessee, 37205-1492

  • Novo Nordisk Investigational Site

    Nashville, Tennessee, 37232

  • Novo Nordisk Investigational Site

    Neenah, Wisconsin, 54956

  • Novo Nordisk Investigational Site

    New Iberia, Louisiana, 70563

  • Novo Nordisk Investigational Site

    New Orleans, Louisiana, 70112

  • Novo Nordisk Investigational Site

    New Orleans, Louisiana, 70115

  • Novo Nordisk Investigational Site

    New Orleans, Louisiana, 70121

  • Novo Nordisk Investigational Site

    New York, New York, 10016

  • Novo Nordisk Investigational Site

    New York, New York, 10021

  • Novo Nordisk Investigational Site

    New York, New York, 10025

  • Novo Nordisk Investigational Site

    Norfolk, Virginia, 23507

  • Novo Nordisk Investigational Site

    North Charleston, South Carolina, 29405

  • Novo Nordisk Investigational Site

    North Platte, Nebraska, 69101

  • Novo Nordisk Investigational Site

    Orangeburg, South Carolina, 29115

  • Novo Nordisk Investigational Site

    Orlando, Florida, 32804

  • Novo Nordisk Investigational Site

    Orlando, Florida, 32806

  • Novo Nordisk Investigational Site

    Oshkosh, Wisconsin, 54904

  • Novo Nordisk Investigational Site

    Panama City, Florida, 32401

  • Novo Nordisk Investigational Site

    Paragould, Arkansas, 72450

  • Novo Nordisk Investigational Site

    Pasadena, California, 91106

  • Novo Nordisk Investigational Site

    Pembroke Pines, Florida, 33024

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania, 19104

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania, 19140

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania, 19144

  • Novo Nordisk Investigational Site

    Phoenix, Arizona, 85012

  • Novo Nordisk Investigational Site

    Pine Bluff, Arkansas, 71603

  • Novo Nordisk Investigational Site

    Pittsburgh, Pennsylvania, 15224

  • Novo Nordisk Investigational Site

    Pittsburgh, Pennsylvania, 15240

  • Novo Nordisk Investigational Site

    Port Washington, New York, 11050

  • Novo Nordisk Investigational Site

    Porterville, California, 93257

  • Novo Nordisk Investigational Site

    Portsmouth, Virginia, 23704

  • Novo Nordisk Investigational Site

    Providence, Rhode Island, 02904

  • Novo Nordisk Investigational Site

    Provo, Utah, 84604

  • Novo Nordisk Investigational Site

    Riverside, California, 92505

  • Novo Nordisk Investigational Site

    Rochester, New York, 14621

  • Novo Nordisk Investigational Site

    Rockville, Maryland, 20852

  • Novo Nordisk Investigational Site

    Roseburg, Oregon, 97471

  • Novo Nordisk Investigational Site

    Rosedale, New York, 11422

  • Novo Nordisk Investigational Site

    Sacramento, California, 95825

  • Novo Nordisk Investigational Site

    Saint Ann, Missouri, 63074

  • Novo Nordisk Investigational Site

    Salem, Virginia, 24153

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78207

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78229

  • Novo Nordisk Investigational Site

    Santee, South Carolina, 29142

  • Novo Nordisk Investigational Site

    Seattle, Washington, 98133

  • Novo Nordisk Investigational Site

    Shreveport, Louisiana, 71101

  • Novo Nordisk Investigational Site

    Silver Spring, Maryland, 20906

  • Novo Nordisk Investigational Site

    Sioux Falls, South Dakota, 57105

  • Novo Nordisk Investigational Site

    Springfield, Massachusetts, 01107

  • Novo Nordisk Investigational Site

    St Louis, Missouri, 63103

  • Novo Nordisk Investigational Site

    St Louis, Missouri, 63108

  • Novo Nordisk Investigational Site

    Stamford, Connecticut, 06902

  • Novo Nordisk Investigational Site

    Sumter, South Carolina, 29150

  • Novo Nordisk Investigational Site

    Tampa, Florida, 33603

  • Novo Nordisk Investigational Site

    Tampa, Florida, 33614

  • Novo Nordisk Investigational Site

    Tempe, Arizona, 85284

  • Novo Nordisk Investigational Site

    The Bronx, New York, 10461

  • Novo Nordisk Investigational Site

    The Bronx, New York, 10467

  • Novo Nordisk Investigational Site

    Toledo, Ohio, 43606

  • Novo Nordisk Investigational Site

    Topeka, Kansas, 66606

  • Novo Nordisk Investigational Site

    Torrance, California, 90502

  • Novo Nordisk Investigational Site

    Tucson, Arizona, 85719

  • Novo Nordisk Investigational Site

    Tuscon, Arizona, 85723

  • Novo Nordisk Investigational Site

    Tyler, Texas, 75701

  • Novo Nordisk Investigational Site

    Vacaville, California, 95687

  • Novo Nordisk Investigational Site

    Visalia, California, 93277

  • Novo Nordisk Investigational Site

    Voorhees Township, New Jersey, 08043

  • Novo Nordisk Investigational Site

    Walnut Creek, California, 94598

  • Novo Nordisk Investigational Site

    Washington D.C., District of Columbia, 20002

  • Novo Nordisk Investigational Site

    Weslaco, Texas, 78596

  • Novo Nordisk Investigational Site

    Weston, Florida, 33331

  • Novo Nordisk Investigational Site

    Whittier, California, 90602

  • Novo Nordisk Investigational Site

    Whittier, California, 90603-2313

  • Novo Nordisk Investigational Site

    Wichita, Kansas, 67214

  • Novo Nordisk Investigational Site

    Wilmington, North Carolina, 28401

  • Novo Nordisk Investigational Site

    Winston-Salem, North Carolina, 27101

  • Novo Nordisk Investigational Site

    Xenia, Ohio, 45385

  • Novo Nordisk Investigational Site

    Yonkers, New York, 10704

  • Novo Nordisk Investigational Site

    Yuba City, California, 95991

  • Novo Nordisk Investigational Site

    Zephyrhills, Florida, 33542

Other trials in United States

Germany27 sites

  • Novo Nordisk Investigational Site

    Aschaffenburg, 63741

  • Novo Nordisk Investigational Site

    Bad Mergentheim, 97980

  • Novo Nordisk Investigational Site

    Bamberg, 96049

  • Novo Nordisk Investigational Site

    Berlin, 10117

  • Novo Nordisk Investigational Site

    Bernkastel-Kues, 54470

  • Novo Nordisk Investigational Site

    Bottrop, 46242

  • Novo Nordisk Investigational Site

    Dormagen, 41539

  • Novo Nordisk Investigational Site

    Düsseldorf, 40210

  • Novo Nordisk Investigational Site

    Elsenfeld, 63820

  • Novo Nordisk Investigational Site

    Fürstenzell, 94081

  • Novo Nordisk Investigational Site

    Gütersloh, 33332

  • Novo Nordisk Investigational Site

    Hamburg, 22297

  • Novo Nordisk Investigational Site

    Hamburg, 22767

  • Novo Nordisk Investigational Site

    Hanover, 30625

  • Novo Nordisk Investigational Site

    Heilbronn, 74076

  • Novo Nordisk Investigational Site

    Kiel, 24106

  • Novo Nordisk Investigational Site

    Krefeld, 47798

  • Novo Nordisk Investigational Site

    Limburg an der Lahn, 65549

  • Novo Nordisk Investigational Site

    Lüdenscheid, 58515

  • Novo Nordisk Investigational Site

    Mettmann, 40822

  • Novo Nordisk Investigational Site

    Minden, 32425

  • Novo Nordisk Investigational Site

    Nettetal, 41334

  • Novo Nordisk Investigational Site

    Passau, 94032

  • Novo Nordisk Investigational Site

    Schweinfurt, 97421

  • Novo Nordisk Investigational Site

    Straubing, 94315

  • Novo Nordisk Investigational Site

    Würzburg, 97072

  • Novo Nordisk Investigational Site

    Würzburg, 97080

Other trials in Germany

France17 sites

  • Novo Nordisk Investigational Site

    Béziers, 34500

  • Novo Nordisk Investigational Site

    Bordeaux, 33000

  • Novo Nordisk Investigational Site

    Bordeaux, 33076

  • Novo Nordisk Investigational Site

    Cherbourt-Octeville, 50102

  • Novo Nordisk Investigational Site

    Clermont-Ferrand, 63000

  • Novo Nordisk Investigational Site

    Dunkirk, 59385

  • Novo Nordisk Investigational Site

    Lyon, 69437

  • Novo Nordisk Investigational Site

    Montpellier, 34295

  • Novo Nordisk Investigational Site

    Muret, 31603

  • Novo Nordisk Investigational Site

    Nantes, 44093

  • Novo Nordisk Investigational Site

    Paris, 75013

  • Novo Nordisk Investigational Site

    Paris, 75015

  • Novo Nordisk Investigational Site

    Paris, 75016

  • Novo Nordisk Investigational Site

    Paris, 75018

  • Novo Nordisk Investigational Site

    Poissy, 78300

  • Novo Nordisk Investigational Site

    Trappes, 78190

  • Novo Nordisk Investigational Site

    Vichy, 3209

Other trials in France

Poland14 sites

  • Novo Nordisk Investigational Site

    Krakow, 31-908

  • Novo Nordisk Investigational Site

    Kraśnik, 23-210

  • Novo Nordisk Investigational Site

    Kwidzyn, 82-500

  • Novo Nordisk Investigational Site

    Myślenice, 32-400

  • Novo Nordisk Investigational Site

    Ostrów Mazowiecka, 07-300

  • Novo Nordisk Investigational Site

    Poznann, 60-355

  • Novo Nordisk Investigational Site

    Puławy, 24-100

  • Novo Nordisk Investigational Site

    Radom, 26-617

  • Novo Nordisk Investigational Site

    Sieradz, 98-200

  • Novo Nordisk Investigational Site

    Słupca, 63-400

  • Novo Nordisk Investigational Site

    Sochaczew, 96-500

  • Novo Nordisk Investigational Site

    Ul Mlynska 5, 33-300

  • Novo Nordisk Investigational Site

    Wejherowo, 84-200

  • Novo Nordisk Investigational Site

    Wroclaw, 51-124

Other trials in Poland

United Kingdom14 sites

  • Novo Nordisk Investigational Site

    Aberdeen, AB25 2ZN

  • Novo Nordisk Investigational Site

    Birmingham, B9 5ST

  • Novo Nordisk Investigational Site

    Cambridge, CB2 2QQ

  • Novo Nordisk Investigational Site

    Coventry, CV2 2DX

  • Novo Nordisk Investigational Site

    Glasgow, G11 6NT

  • Novo Nordisk Investigational Site

    Leicester, LE5 4PW

  • Novo Nordisk Investigational Site

    Liverpool, L69 3GA

  • Novo Nordisk Investigational Site

    London, NW3 2QG

  • Novo Nordisk Investigational Site

    Londonderry, BT47 6SB

  • Novo Nordisk Investigational Site

    Manchester, M13 9WL

  • Novo Nordisk Investigational Site

    Rhyl, LL18 5UJ

  • Novo Nordisk Investigational Site

    Sheffield, S5 7AU

  • Novo Nordisk Investigational Site

    Swansea, SA6 6NL

  • Novo Nordisk Investigational Site

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Brazil11 sites

  • Novo Nordisk Investigational Site

    Curitiba, 81050-090

  • Novo Nordisk Investigational Site

    Fortaleza, 60336-550

  • Novo Nordisk Investigational Site

    Fortaleza, 60430-370

  • Novo Nordisk Investigational Site

    Jaboatao de Guararapes, 54400-170

  • Novo Nordisk Investigational Site

    Porto Alegre, 90035-903

  • Novo Nordisk Investigational Site

    Porto Alegre, 90420090

  • Novo Nordisk Investigational Site

    Porto Alegre, 90610000

  • Novo Nordisk Investigational Site

    Rio de Janeiro, Rio de Janeiro, 22260-020

  • Novo Nordisk Investigational Site

    São José Rio Preto, 15090-000

  • Novo Nordisk Investigational Site

    São Paulo, 04039001

  • Novo Nordisk Investigational Site

    Sorocaba, 18030-083

Other trials in Brazil

Canada11 sites

  • Novo Nordisk Investigational Site

    Edmonton, Alberta, T6G 2B7

  • Novo Nordisk Investigational Site

    Greenfield Park, J4V 2H1

  • Novo Nordisk Investigational Site

    Halifax, Nova Scotia, B3H 1V7

  • Novo Nordisk Investigational Site

    London, N6A 5A5

  • Novo Nordisk Investigational Site

    Montreal, Quebec, HIT 2M4

  • Novo Nordisk Investigational Site

    Peterborough, K9J 7C6

  • Novo Nordisk Investigational Site

    Regina, S4P 0W5

  • Novo Nordisk Investigational Site

    Saskatoon, S7M 2Z1

  • Novo Nordisk Investigational Site

    Scarborough, M1H 3G4

  • Novo Nordisk Investigational Site

    Thunder Bay, P7B 6V4

  • Novo Nordisk Investigational Site

    Toronto, Ontario, M5B 1W8

Other trials in Canada

Argentina10 sites

  • Novo Nordisk Investigational Site

    Buenos Aires, B1636DSU

  • Novo Nordisk Investigational Site

    Buenos Aires, C1181ACH

  • Novo Nordisk Investigational Site

    Capital Federal, C1425BPM

  • Novo Nordisk Investigational Site

    Capital Federal, C1431FWO

  • Novo Nordisk Investigational Site

    Córdoba, X5002HWE

  • Novo Nordisk Investigational Site

    Morón, B1708DPO

  • Novo Nordisk Investigational Site

    Pergamino, B2700CPM

  • Novo Nordisk Investigational Site

    San Miguel de Tucumán, 4000

  • Novo Nordisk Investigational Site

    Sarandí, B1872EEA

  • Novo Nordisk Investigational Site

    Temperley, 1834

Other trials in Argentina

Portugal10 sites

  • Novo Nordisk Investigational Site

    Abrantes, 2200-233

  • Novo Nordisk Investigational Site

    Amadora, 2700-473

  • Novo Nordisk Investigational Site

    Braga, 4710-391

  • Novo Nordisk Investigational Site

    Corroios, 2855-227

  • Novo Nordisk Investigational Site

    Entroncamento, 2330-108

  • Novo Nordisk Investigational Site

    Evora, 7000-711

  • Novo Nordisk Investigational Site

    Setúbal, 2900-655

  • Novo Nordisk Investigational Site

    Torres Vedras, 2560-272

  • Novo Nordisk Investigational Site

    Villa Franca de Xira, 2600-076

  • Novo Nordisk Investigational Site

    Villa Nova de Gaia, 4430-196

Other trials in Portugal

Russia8 sites

  • Novo Nordisk Investigational Site

    Moscow, 123182

  • Novo Nordisk Investigational Site

    Moscow, 125284

  • Novo Nordisk Investigational Site

    Petrozavodsk, 185019

  • Novo Nordisk Investigational Site

    Saint Petersburg, 191015

  • Novo Nordisk Investigational Site

    Saint Petersburg, 191104

  • Novo Nordisk Investigational Site

    Saint Petersburg, 195067

  • Novo Nordisk Investigational Site

    Saint Petersburg, 195257

  • Novo Nordisk Investigational Site

    Saint Petersburg, 197022

Other trials in Russia

Spain8 sites

  • Novo Nordisk Investigational Site

    Barcelona, 8029

  • Novo Nordisk Investigational Site

    Burgos, 9006

  • Novo Nordisk Investigational Site

    Córdoba, 14005

  • Novo Nordisk Investigational Site

    Granollers, 8401

  • Novo Nordisk Investigational Site

    Madrid, 28006

  • Novo Nordisk Investigational Site

    Santander, 39001

  • Novo Nordisk Investigational Site

    Seville, 41013

  • Novo Nordisk Investigational Site

    Valencia, 96007

Other trials in Spain

Denmark7 sites

  • Novo Nordisk Investigational Site

    Aalborg, 9100

  • Novo Nordisk Investigational Site

    Arhus N, 8200

  • Novo Nordisk Investigational Site

    Copenhagen, 2100

  • Novo Nordisk Investigational Site

    Herlev, 2730

  • Novo Nordisk Investigational Site

    Hilleroed, 3400

  • Novo Nordisk Investigational Site

    Holbæk, 4300

  • Novo Nordisk Investigational Site

    Odense, 5000

Other trials in Denmark

Israel7 sites

  • Novo Nordisk Investigational Site

    Ashkelon, 78278

  • Novo Nordisk Investigational Site

    Hadera, 38100

  • Novo Nordisk Investigational Site

    Haifa, 34362

  • Novo Nordisk Investigational Site

    Jerusalem

  • Novo Nordisk Investigational Site

    Petah Tikva, 49100

  • Novo Nordisk Investigational Site

    Rehovot

  • Novo Nordisk Investigational Site

    Tzriffin, 70300

Other trials in Israel

Italy6 sites

  • Novo Nordisk Investigational Site

    Bologna, 40138

  • Novo Nordisk Investigational Site

    Brescia, 23125

  • Novo Nordisk Investigational Site

    Genova, 16132

  • Novo Nordisk Investigational Site

    Milan, 20142

  • Novo Nordisk Investigational Site

    Modena, 41100

  • Novo Nordisk Investigational Site

    Pavia, 27100

Other trials in Italy

Hungary5 sites

  • Novo Nordisk Investigational Site

    Budapest, 1083

  • Novo Nordisk Investigational Site

    Budapest, 1097

  • Novo Nordisk Investigational Site

    Eger, 3300

  • Novo Nordisk Investigational Site

    Kecskemét, 6001

  • Novo Nordisk Investigational Site

    Sopron, 9400

Other trials in Hungary

China4 sites

  • Novo Nordisk Investigational Site

    Beijing, Beijing Municipality, 100050

  • Novo Nordisk Investigational Site

    Beijing, Beijing Municipality, 100853

  • Novo Nordisk Investigational Site

    Nanjing, Jiangsu, 210009

  • Novo Nordisk Investigational Site

    Shanghai, Shanghai Municipality, 200001

Other trials in China

Turkey (Türkiye)4 sites

  • Novo Nordisk Investigational Site

    Ankara, 06500

  • Novo Nordisk Investigational Site

    Istanbul, 34360

  • Novo Nordisk Investigational Site

    Istanbul, 34390

  • Novo Nordisk Investigational Site

    Istanbul, 34668

Other trials in Turkey (Türkiye)

India3 sites

  • Novo Nordisk Investigational Site

    Hyderabad, Andhra Pradesh, 500082

  • Novo Nordisk Investigational Site

    Hyderabad, 500034

  • Novo Nordisk Investigational Site

    Pune, 411011

Other trials in India

Sweden3 sites

  • Novo Nordisk Investigational Site

    Stockholm, 182 88

  • Novo Nordisk Investigational Site

    Uppsala, 751 85

  • Novo Nordisk Investigational Site

    Värnamo, 331 85

Other trials in Sweden

South Africa2 sites

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng, 2013

  • Novo Nordisk Investigational Site

    Obervatory, 7925

Other trials in South Africa

Puerto Rico1 site

  • Novo Nordisk Investigational Site

    Ponce, 00717

Other trials in Puerto Rico

About this study

Official title: Efficacy and Safety of Somatropin in Adult Patients on Chronic Haemodialysis

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.

Read the detailed 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.

Being tested
somatropin, placebo
Medical subject headings
Renal Insufficiency, Chronic, Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • somatropinDrug

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

  • placeboDrug

    Placebo injected s.c (under the skin)

Study groups in NCT00503698
Study groupRoleWhat they receive
SomatropinExperimentalSomatropin once daily from week 0 to end of trial
Receives: Drug: somatropin
PlaceboPlacebo comparatorPlacebo once daily to end of trial
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: week 0, trial termination

Secondary outcomes (4)

  1. 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.

    Measured: week 0, trial termination

  2. 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.

    Measured: week 0, trial termination

  3. Mortality - Two-year Mortality Rate

    Measured: week 0, trial termination

  4. 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.

    Measured: week 0, trial termination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionDec 2008
  4. Study completionDec 2008

Why it stopped: See termination reason in detailed description

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
712 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00503698
Sponsor's protocol ID
NN1630-1453
Other IDs
2006-004702-56
Acronym
OPPORTUNITY
Status last verified
Jan 2017
First submitted
18 Jul 2007
Last updated
7 Mar 2017
Data monitoring committee
Yes

Publications

  • Kopple JD, Cheung AK, Christiansen JS, Djurhuus CB, El Nahas M, Feldt-Rasmussen B, Lange M, Mitch WE, Wanner C, Wiedemann J, Ikizler TA. OPPORTUNITY: a randomized clinical trial of growth hormone on outcome in hemodialysis patients. Clin J Am Soc Nephrol. 2008 Nov;3(6):1741-51. doi: 10.2215/CJN.02760608.

    PubMed 18945992

  • Raff AC, Meyer TW, Hostetter TH. New insights into uremic toxicity. Curr Opin Nephrol Hypertens. 2008 Nov;17(6):560-5. doi: 10.1097/MNH.0b013e32830f45b6.

    PubMed 18941347

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing somatropin in people with Chronic Kidney Disease and End-Stage Renal Disease, run by Novo Nordisk A/S at 381 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 381 sites in United States, Germany, France, Poland, United Kingdom and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality - Time to All-cause Death (time frame: week 0, trial termination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00503698, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2017.

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