AzTrials
AzTrials

Chronic Renal AnemiaPhase 4NCT00773513

A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs)

A Phase 4 study testing Darbepoetin Alfa, Epoetin Alfa and Epoetin Beta in people with Chronic Renal Anemia, run by Hoffmann-La Roche at 196 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This 2 arm safety study will compare the outcome with respect to a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction, stroke) in CKD participants either on dialysis or not receiving renal replacement therapy under treatment with methoxy polyethylene glycol-epoetin… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Renal Anemia
What is being tested?
Darbepoetin Alfa, Epoetin Alfa and Epoetin Beta
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,825 participants
Where
196 sitesin 27 countries
Study dates
12 Dec 2008to 27 Jul 2017
Phase
Phase 4
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

  • Male or female participants with symptomatic anemia associated with CKD
  • Participants with renal anemia who are not treated with an ESA:
  • Anemia was defined as hemoglobin (Hb) concentration less than (<) 11.0 grams per deciliter (g/dL) (mean of 2 screening values with at least one day and a maximum of 2 weeks between measurements) with clinical indication for ESA treatment
  • Participants with renal anemia who are on maintenance ESA therapy:
  • If on dialysis: regular long-term hemodialysis or peritoneal dialysis therapy with the same mode of dialysis for at least 3 months before screening
  • Hb concentration between 10 and 12 g/dL (mean of 2 screening values with at least one day and a maximum of 2 weeks between measurements)
  • Participants with adequate iron status defined as: serum ferritin above or equal to 100 micrograms per liter or transferrin saturation above or equal to 20 percent

Who cannot join

  • Contraindications to ESA treatment: uncontrolled hypertension, hypersensitivity to the active substance or any of the excipients, any other contraindication to ESA therapy
  • Conditions known to cause inadequate response to ESA treatment or anemia other than symptomatic anemia associated with CKD:
  • History of hemoglobinopathy
  • Anemia due to hemolysis
  • Pure red cell aplasia
  • High likelihood of early withdrawal (for example, within 1 year) or interruption of the study
Show all 9Show fewer
  • Pregnancy or breast-feeding
  • Women of childbearing potential without effective contraception
  • Administration of another investigational drug within 1 month before screening or planned during the study period

Trial locations and contacts

196 sites in 27 countries.

196 sites in 27 countries

Italy28 sites

  • Ospedale S. Marta S. Venera Nuovo; U.O. Nefrologia Dialisi

    Acireale, Sicily, 95024

  • Ospedale Caduti Bollatesi; U.O. Nefrologia E Dialisi

    Bollate, Lombardy, 20021

  • Ospedale Bernardo Ramazzi; U.O. Di Nefrologia E Dialisi

    Carpi, Emilia-Romagna, 41012

  • Ospedale S. Giacomo; U.O. Di Nefrologia e Dialisi

    Castelfranco, Veneto, 31033

  • Azienda Ospedaliera Cannizzaro Unità Operativa Nefrologia

    Catania, Sicily, 95126

  • Azienda Ospedaliera Sant'Anna Unità Operativa Complessa di Nefrologia Dialisi

    Cona (FE), Veneto, 44124

  • P.O. Di Conegliano; U.O. Di Nefrologia E Dialisi

    Conegliano, Veneto, 31015

  • A.O. Universitaria S. Martino Di Genova; Nefrologia

    Genoa, Liguria, 16132

  • Ospedale Civile; Servizio Di Nefrologia E Dialisi

    Imola, Emilia-Romagna, 40026

  • ASST DI LECCO; Nefrologia e Dialisi

    Lecco, Lombardy, 23900

  • Presidio Ospedaliero Di Lodi; U.O. Nefrologia E Dialisi

    LODI, Tuscany, 26900

  • A.O.U. Policlinico G.Martino; U.O.C. Nefrologia e Dialisi

    Messina, Sicily, 98147

  • Presidio Ospedaliero Maggiore Policlinico Fondazione IRCCS; Pad Croff Div Nefrologia Dialisi

    Milan, Lombardy, 20122

  • ASST SANTI PAOLO E CARLO; U.O.S. Nefrologia e Dialisi

    Milan, Lombardy, 20153

  • ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Dipartimento di Nefrologia e Dialisi

    Milan, Lombardy, 20162

  • A.O. Universitaria Policlinico Di Modena; Nefrologia E Dialisi

    Modena, Emilia-Romagna, 41100

  • Az. Osp. Di Padova; U.O. Nefrologia 2 E Dialisi

    Padova, Veneto, 35128

  • Ospedale Maggiore; U.O.Complessa di Nefrologia e Dialisi

    Parma, Emilia-Romagna, 43100

  • Fondazione Salvatore Maugeri; Divisione Di Nefrologia E Dialisi

    Pavia, Lombardy, 27100

  • Azienda Ospedaliera San Salvatore; Divisione Nefrologia E Dialisi

    Pesaro, The Marches, 61100

  • Ospedale Civile; Divisione de Nefrologia E Dialisi

    Piacenza, Emilia-Romagna, 29100

  • Nuovo Ospedale Di Prato

    Prato, Tuscany, 50047

  • Ospedale Provinciale S. Maria delle Croci; Divisione Nefrologia e Dialsi

    Ravenna, Emilia-Romagna, 48100

  • A.O. Santa Maria Nuova Di Reggio Emilia; Unita Operativa Di Nefrologia E Dialisi

    Reggio Emilia, Emilia-Romagna, 42100

  • Universita' Di Tor Vergata; Clinica Nefrologia Dialisi

    Rome, Lazio, 00100

  • Azienda Ospedaliera Santa Maria Misericordia; Divisione Nefrologia Dialisi

    Rovigo, Veneto, 45100

  • ASST LARIANA; Divisione di Nefrologia e Dialisi

    S Fermo Della Battaglia, Lombardy, 22020

  • A.O. Cà Foncello; U.O.Nefrologia, Dialisi e Centro Trapianti

    Treviso, Veneto, 31100

Other trials in Italy

United Kingdom23 sites

  • Ulster Hospital; Nephrology

    Belfast, BT16 1RH

  • Belfast City Hospital; Nephrology Unit

    Belfast, BT9 7LJ

  • St Luke'S Hospital; Renal Unit

    Bradford, BD5 0NA

  • University Hospital of Wales; Institute of Nephrology

    Cardiff, CF14 4XW

  • St Helier Hospital; Renal Unit

    Carshalton, SM5 1AA

  • University Hospital Coventry And Warwickshire Nhs Trust; Department Of Nephrology

    Coventry, CV2 2DX

  • Dorset County Hospital; Renal Unit

    Dorchester, DT1 1TS

  • Royal Devon & Exeter Hospital; Dept of Nephrology

    Exeter, EX2 5DW

  • Hull Royal Infirmary; Renal Medicine

    Hull, HU3 2JZ

  • The Ipswich Hospital Nhs Trust; The Renal Unit

    Ipswich, IP4 5PD

  • St James Uni Hospital; Renal Unit

    Leeds, LS9 7TF

  • Leicester General Hospital; Dept of Nephrology

    Leicester, LE5 4PW

  • Royal Free & University College Medical School; Centre for Nephrology

    London, NW3 2PF

  • James Cook Hospital; Nephrology

    Middlesbrough, TS4 3BW

  • Freeman Hospital; Nephrology

    Newcastle upon Tyne, NE7 7DN

  • The Churchill; Oxford Kidney Unit

    Oxford, OX3 7LJ

  • Derriford Hospital; Department Of Renal Medicine

    Plymouth, PL6 8DH

  • Royal Preston Hospital; Department of Renal Medicine

    Preston, PR2 9HT

  • Salford Royal Foundation Trust; Department Of Nephrology

    Salford, M6 8HD

  • Royal Shrewsbury Hospital

    Shrewsbury, SY3 8XQ

  • Morriston Hospital; Renal Medicine

    Swansea, SA6 6NL

  • Royal Cornwall Hospital; Renal Unit

    Truro, TR1 3LJ

  • Worthing Hospital; Renal Unit

    West Sussex, BN11 2DH

Other trials in United Kingdom

France18 sites

  • Centre Hospitalier; Hemodialyse

    Annonay, 07103

  • Hopital Pellegrin; Departement Nephrologie

    Bordeaux, 33076

  • Centre Hospitalier Du Dr Duchenes; Service De Nephrologie & Hemodialyse

    Boulogne, 62321

  • Hopital La Cavale Blanche; Nephrologie

    Brest, 29609

  • Hopital Louis Pasteur; Nephrologie - Hemodialyse

    Colmar, 68024

  • Clinique Lambert; Service de Néphrologie dialyse

    La Garenne-Colombes, 92250

  • Chu Dupuytren; Nephrologie-Hemodialyse

    Limoges, 87042

  • Aural

    Lyon, 69008

  • Hopital Edouard-Herriot; Nephrologie - Hemodialyse

    Lyon, 69437

  • Centre Hospitalier Les Chanaux; Service de Néphrologie Unité 12

    Mâcon, 71018

  • Service de Nephrologie & D'Immunologie; Clinique

    Nantes, 44035

  • Centre Hospitalier Uni Ire Gaston Doumergue; Service D'Hemodialyse

    Nîmes, 30059

  • Aura - Centre Henri Kunt Ziger

    Paris, 75014

  • Hopital Laennec; Echo

    Saint-Herblain, 44805

  • Hopital Sud ; Nephrologie Hemodialyse

    Salouël, 80480

  • Hopital Civil; Nephrologie Clinique Medicale B

    Strasbourg, 67091

  • Hopital Rangueil; Nephrologie Hemodialyse

    Toulouse, 31059

  • Ch De Valenciennes; Nephrologie

    Valenciennes, 59322

Other trials in France

Germany18 sites

  • Gemeinschaftspraxis Dr. Stefan Zinn und Steffen Hengst

    Alsfeld, 36304

  • KFH Nierenzentrum Bad Hersfeld; Nephrologie

    Bad Hersfeld, 36251

  • Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin

    Bonn, 53127

  • Dialysepraxis Dr. med. Uwe Kraatz

    Demmin, 17109

  • DaVita Clinical Research Deutschland GmbH

    Düsseldorf, 40210

  • Universitätsklinikum Duesseldorf; Klinik fuer Nephrologie

    Düsseldorf, 40225

  • Universitätsklinikum Erlangen; Medizinische Klinik 4; Nephrologie und Hypertensiologie

    Erlangen, 91054

  • Georg-Haas-Dialysezentrum der PHV

    Giessen, 35392

  • Nephrologische Schwerpunktpraxis; Hamburg Barmbek

    Hamburg, 22297

  • Klinikum Hann. Münden, Nephrologisches Zentrum Niedersachsen

    Hannoversch Münden, 34346

  • Uniklinikum Heidelberg

    Heidelberg, 69120

  • Universitaetsklinikum des Saarlandes; Klinik f. Innere Medizin IV

    Homburg/Saar, 66424

  • UNI-Klinikum Campus Kiel Klinik f.Innere Medizin IV

    Kiel, 24105

  • KfH Kuratorium für Dialyse und Nierentransplantation e.V.; KfH-Nierenzentrum

    München, 80804

  • KFH Nierenzentrum Oberschleissheim

    Oberschleißheim, 85764

  • Dres. Roland Erwin Winkler Ann Michelsen Dietmar Sehland u.w.

    Rostock, 18107

  • Praxis Dr.med. Joachim Leicht

    Schwandorf in Bayern, 92421

  • Robert-Bosch-Krankenhaus; Allgemeine Innere Medizin und Nephrologie

    Stuttgart, 70376

Other trials in Germany

Poland14 sites

  • Akademia Medyczna; Klinika Nefrologii I Chorob Wewnetrznych

    Bydgoszcz, 85-094

  • Specjalistyczny Szpital Wojewodzki w Ciechanowie; Oddzial Nefrologiczny

    Ciechanów, 06-400

  • Fresenius Nephrocare Polska Sp zo.o.Centrum Dializ Fresenius Osrodek Dializ Nr 45 w Dabrowie Tarn

    Dąbrowa Tarnowska, 33-200

  • NZOZ Stacja Dializ Hand-Prod w Gorlicach

    Gorlice, 38-300

  • Fresenius Nephrocare Polska Sp zo.o. Centrum Dializ Fresenius Osrodek Dializ Nr 42 w Jasle

    Jasło, 38-200

  • NZOZ Stacja Dializ Hand-Prod w Limanowej

    Limanowa, 34-600

  • Fresenius Nephrocare Polska Sp. z o.o., Centrum Dializ Fresenius, Osrodek Dializ nr 53 w Pabianicach

    Pabianice, 95-200

  • Fresenius Nephrocare Polska Sp. z o.o., Centrum Dializ Fresenius, Osrodek Dializ numer 71 w Poznaniu

    Poznan, 61-485

  • Stacja Dializ NZOZ Centrum Medyczne MEDYK

    Rzeszów, 35-055

  • Fresenius Nephrocare Polska Sp.zo.o.Centrum Dializ FreseniusOśrodek Dializ Nr 62 w Sandomierzu

    Sandomierz, 27-600

  • Wojewodzki Szpital Zespolony, Stacja Dializ, Skierniewice

    Skierniewice, 96-100

  • Powiatowy Szpital Specjalistyczny w Stalowej Woli; Oddział Nefrologii i Dializoterapii

    Stalowa Wola, 37-450

  • Specjalistyczny Szpital im A.Sokołowskiego w Wałbrzychu; Oddzial Nefrologiczny

    Wałbrzych, 58-309

  • S.P. Szpital Wojewodzki im. Papieza Jana Pawla II

    Zamość, 22-400

Other trials in Poland

Spain13 sites

  • Complejo Hospitalario Torrecardenas; Servicio de Nefrologia

    Almería, Almeria, 04009

  • Hospital de Cruces; Servicio de Nefrologia

    Barakaldo, Vizcaya, 48903

  • Hospital del Mar; Servicio de Nefrologia

    Barcelona, 08003

  • Hospital de Basurto; Servicio de Nefrologia

    Bilbao, Vizcaya, 48013

  • Hospital de Galdakano; Servicio de Nefrologia

    Galdakao, Vizcaya, 48960

  • Hospital Universitario San Cecilio

    Granada, 18012

  • Complejo Hospitalario de Jaen- Hospital Universitario Medico Quirurgico

    Jaén, 23007

  • Hospital Severo Ochoa; Servicio de Nefrologia

    Leganés, Madrid, 28911

  • Hospital Ramon y Cajal; Servicio de Nefrologia

    Madrid, 28034

  • Hospital Clinico San Carlos; Servicio de Nefrologia

    Madrid, 28040

  • Hospital de Navarra; Servicio de Nefrologia

    Pamplona, Navarre, 31008

  • Hospital Infanta Sofia; Servico de Nefrologia

    San Sebastián de los Reyes, Madrid, 28702

  • Hospital Txagorritxu; Servicio de Nefrologia

    Vitoria-Gasteiz, Alava, 01009

Other trials in Spain

Brazil10 sites

  • PUCPR

    Curitiba, Paraná, 80050-350

  • Centro Mineiro de Pesquisa - CMIP

    Juiz de Fora, Minas Gerais, 36036-330

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital Univ. Pedro Ernesto - Hupe; Nefrologia

    Rio de Janeiro, Rio de Janeiro, 20551-030

  • Beneficencia Portuguesa de Sao Paulo

    São Paulo, São Paulo, 01323-900

  • Universidade Federal de Sao Paulo - UNIFESP

    São Paulo, São Paulo, 04038-002

  • Clinica de Medicina Interna e Nefrologia (CMIN)

    São Paulo, São Paulo, 05001-000

  • Hospital das Clinicas - FMUSP; Nefrologia

    São Paulo, São Paulo, 05403-000

  • Instituto de Hemodialise Sorocaba

    Sorocaba, São Paulo, 18040-335

Other trials in Brazil

Australia8 sites

  • ROYAL ADELAIDE HOSPITAL; Renal Clinical Trials, CNARTS

    Adelaide, South Australia, 5000

  • Cairns Hospital; Renal Services

    Cairns, Queensland, 4870

  • Monash Medical Centre; Renal Transplant Unit

    Clayton, Victoria, 3186

  • Gosford Hospital; Renal

    Gosford, New South Wales, 2250

  • Renal Research Dr Simon Roger

    Gosford, New South Wales, 2250

  • Launceston General Hospital; Diabetes and Renal Research Unit

    Launceston, Tasmania, 7250

  • Royal Perth Hospital; Nephrology

    Perth, Western Australia, 6847

  • Gold Coast Hospital Department of Pharmacology & Therapeutics

    Southport, Queensland, 4215

Other trials in Australia

Croatia7 sites

  • General Hospital Karlovac; Dept of Haemodialysis

    Karlovac, 47000

  • Clinical Hospital Osijek; Dept of Haemodialysis

    Osijek, 31000

  • Clinical Hospital Center Rijeka; Dialysis

    Rijeka, 51000

  • General Hospital Josip Bencevic; Department of Haemodialysis

    Slavonski Brod, 35000

  • Clinical Hospital Split; Dialysis

    Split, 21000

  • General Hospital Zadar; Dialysis

    Zadar, 23000

  • Klinicki Bolnicki Centar Zagreb; Dialysis

    Zagreb, 10000

Other trials in Croatia

Belgium5 sites

  • UZ Brussel

    Brussels, 1090

  • UZ Gent

    Ghent, 9000

  • Jessa Zkh (Campus Virga Jesse)

    Hasselt, 3500

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • AZ Delta (Campus Wilgenstraat)

    Roeselare, 8800

Other trials in Belgium

Greece5 sites

  • Uni Hospital of Alexandroupoli; Nephrology Dept.

    Alexandroupoli, 68100

  • Laiko General Hospital; Nephrology Div.

    Athens, 115 27

  • Uni Hospital of Ioannina; Nephrology Dept.

    Ioannina, 455 00

  • Univeristy Hospital of Larissa; Nephrology

    Larissa, 41 110

  • Hippokratio Hospital; Nefrology

    Thessaloniki, 546 42

Other trials in Greece

Israel5 sites

  • Rabin MC- Belinson campus

    Petah Tikva, 49100

  • Rabin MC- Hasharon campus

    Petah Tikva, 4937211

  • Sheba MC; Nephrology

    Ramat Gan, 52621

  • Sourasky MC; Dept. of Nephrology

    Tel Aviv, 6423906

  • Assaf-Harofeh MC; Nephrology

    Zrifin, 70300

Other trials in Israel

Serbia5 sites

  • Clinical Center of Serbia; Clinic of Urology

    Belgrade, 11000

  • Clinical Hospital Center Zvezdara

    Belgrade, 11000

  • Zemun Hospital; Nephrology

    Belgrade, 11000

  • Clinical Center Nis; Clinic for Nephrology and Hemodialysis

    Niš, 18000

  • Clinical Center Voivodina; Clinic for Immunology and Nephrology

    Novi Sad, 21000

Other trials in Serbia

Argentina4 sites

  • Fresenius Medical Care Martinez

    Buenos Aires, 1640

  • Fresenius Medical Care Morón

    Buenos Aires, 1708

  • Fresenius Medical Care San Martin

    Buenos Aires, B1650IHM

  • Fresenuis Medical Care Mansilla

    CABA, 1425

Other trials in Argentina

Czechia4 sites

  • Fakultni Nemocnice Kralovske Vinohrady (FNKV); Interni Hematologicka Klinika

    Hradec Králové, 500 05

  • Faculty Hospital; Dialysis Unit

    Ostrava, 708 52

  • Institut Klinicke A Experimentalni Mediciny Klinika Nefrologie

    Prague, 140 21

  • Nemocnice Strahov; Interni Oddeleni-Strahov

    Prague, 169 00

Other trials in Czechia

Russia4 sites

  • SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF

    Saint Petersburg, Sankt-Peterburg, 197022

  • St.Petersburg State Budget Institution of Healthcare "City Mariinskaya Hospital"

    Saint Petersburg, 191104

  • SBEI of HPE "Northwestern State Medical University n.a. I.I.Mechnikov" of MoH of RF

    Saint Petersburg, 195067

  • St.Petersburg State Budget Institution of Healthcare "City Hospital Saint Hosiomartyr Elisabeth".

    Saint Petersburg, 195257

Other trials in Russia

Malaysia3 sites

  • University Malaya Medical Centre; Division of Nephrology, Department of Medicine

    Kuala Lumpur, FED. Territory of Kuala Lumpur, 50603

  • Hospital Kuala Lumpur; Department of Medicine

    Kuala Lumpur, 50586

  • Selayang Hospital; Dept of Medicine

    Kuala Selangor, 68100

Other trials in Malaysia

Singapore3 sites

  • National University Hospital; Dept of Medicine

    Singapore, 117599

  • Singapore General Hospital; Renal Medicine

    Singapore, 169608

  • Tan Tock Seng Hospital; Department of Renal Medicine

    Singapore, 308433

Other trials in Singapore

Sweden3 sites

  • Danderyds Sjukhus; Dept. of Nephrology

    Danderyd, 18288

  • Maelar Hospital; Department of Medicine

    Eskilstuna, 63188

  • Uppsala University Hospital; Department of Internal Medicine, Nephrology Section

    Uppsala, 75185

Other trials in Sweden

Thailand3 sites

  • King Chulalongkorn Memorial Hospital; Renal Unit, Department of Medicine

    Bangkok, 10310

  • Maharaj Nakorn Chiang Mai Hospital; Dept. of Medicine, Renal Division

    Chiang Mai, 50200

  • Buddhachinaraj Hospital Renal Division; Dept of Medicine

    Phitsanulok, 65000

Other trials in Thailand

Turkey (Türkiye)3 sites

  • Cukurova University School of Medicine; Nefrology Department

    Adana, 01100

  • Baskent University Hospital; Transplantation

    Ankara, 06490

  • Inonu Uni School of Medicine

    Malatya, 44300

Other trials in Turkey (Türkiye)

Lithuania2 sites

  • Hospital of Lithuanian University of Health. Sciences Kaunas Clinics

    Kaunas, 50009

  • Vilnius University Hospital Santariskiu Clinic, Nephrology Center

    Vilnius, 08661

Other trials in Lithuania

Philippines2 sites

  • Cebu Doctors University Hospital

    Cebu City, 6000

  • National Kidney and Transplant Institute

    Quezon City, 1100

Other trials in Philippines

South Korea2 sites

  • Seoul National Uni Hospital; Internal Medicine

    Seoul, 03080

  • Samsung Medical Center; Nephrology Department

    Seoul, 06351

Other trials in South Korea

Taiwan2 sites

  • Chang Gung Medical Fundation Kaohsiung Branch; Nephrology

    Kaohsiung City, 833

  • National Taiwan Uni Hospital; Nephrology Dept

    Taipei, 100

Other trials in Taiwan

Mexico1 site

  • Investigación Nefrológica S.C.

    Cuernavaca, Morelos, 62448

Other trials in Mexico

Panama1 site

  • Centro Especializado San Fernando; Nefrología, Diálisis y Trasplante Renal

    Panama City, 0834-02723

Other trials in Panama

About this study

Official title: A Randomized, Controlled, Open-Label, Multi-Centre, Parallel-Group Study To Assess All-Cause Mortality And Cardiovascular Morbidity In Patients With Chronic Kidney Disease On Dialysis And Those Not On Renal Replacement Therapy Under Treatment With MIRCERA® Or Reference ESAs.

This 2 arm safety study will compare the outcome with respect to a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction, stroke) in CKD participants either on dialysis or not receiving renal replacement therapy under treatment with methoxy polyethylene glycol-epoetin beta or reference ESAs. Participants will be randomized to receive intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta at the following doses: for participants not already receiving ESA treatment, methoxy polyethylene glycol-epoetin beta will be administered at a starting dose of 0.6 micrograms per kilograms every 2 weeks (mcg/kg/2wks) iv or sc; for participants receiving maintenance ESA treatment, iv or sc methoxy polyethylene glycol-epoetin beta will be administered at an initial monthly dose of 120, 200 or 360 micrograms (mcg) depending on the weekly dose of ESA received prior to first methoxy polyethylene glycol-epoetin beta administration. Participants randomized to reference ESA treatment will receive iv or sc ESAs in accordance with their prescribed dosing information.

Being tested
Darbepoetin Alfa, Epoetin Alfa, Epoetin Beta, methoxy polyethylene glycol-epoetin beta

What participants receive

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

  • Darbepoetin AlfaDrug

    Also called Aranesp®, Nespo®, Aranest®

    Darbepoetin alfa will be administered as per approved label.

  • Epoetin AlfaDrug

    Also called Eprex®, Epogen®, Epopen®, Erypo®

    Epoetin alfa will be administered as per approved label.

  • Epoetin BetaDrug

    Also called Neorecormon®, Recormon®

    Epoetin beta will be administered as per approved label.

  • methoxy polyethylene glycol-epoetin betaDrug

    Also called Mircera®

    Participants who are currently not being treated with an ESA will receive methoxy polyethylene glycol-epoetin beta administered at a starting dose of 0.6 mcg/kg body weight once every 2 weeks. Participants who are currently being treated with an ESA will receive methoxy polyethylene glycol-epoetin beta at a dose of 120, 200 or 360 mcg once monthly (based on ESA dose administered in Week -1)

Study groups in NCT00773513
Study groupRoleWhat they receive
Erythropoiesis Stimulating AgentsActive comparatorParticipants will receive reference ESA according to approved label. The approved reference ESA compounds in the study will be darbepoetin alfa, epoetin alfa and epoetin beta.
Receives: Drug: Darbepoetin Alfa; Drug: Epoetin Alfa; Drug: Epoetin Beta; Drug: methoxy polyethylene glycol-epoetin beta
Methoxy Polyethylene Glycol-Epoetin BetaExperimentalParticipants not currently being treated with an ESA will receive methoxy polyethylene glycol-epoetin beta iv or sc once every 2 weeks for correction of renal anemia (target Hb 10-12 g/dL). Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta will be administered once monthly.
Receives: Drug: Darbepoetin Alfa; Drug: Epoetin Alfa; Drug: methoxy polyethylene glycol-epoetin beta

What is being measured

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

  1. Time to Composite of All-Cause Mortality and Non-Fatal Cardiovascular Events (Myocardial Infarction, Stroke) Defined as Time Between First Dose of Study Medication and Date of Death or Non-Fatal Cardiovascular Events, Whichever Occurred First

    Measured: Baseline up to approximately 8.5 years

Secondary outcomes (7)

  1. Time to All-Cause Mortality

    Measured: Baseline up to approximately 8.5 years

  2. Time to Non-Fatal and Fatal Myocardial Infarction

    Measured: Baseline up to approximately 8.5 years

  3. Time to Non-Fatal and Fatal Stroke

    Measured: Baseline up to approximately 8.5 years

  4. Time to Non-Fatal Cardiovascular Events (Myocardial Infarction or Stroke, Whichever Occurred First)

    Measured: Baseline up to approximately 8.5 years

  5. Percentage of Participants With Anti-Erythropoietin Antibody-Mediated Pure Red Cell Aplasia (PRCA)

    Measured: Baseline up to approximately 8.5 years

  6. Percentage of Participants With Gastrointestinal Bleeding

    Measured: Baseline up to approximately 8.5 years

  7. Percentage of Participants With Thromboembolic Events

    Measured: Baseline up to approximately 8.5 years

Timeline

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

  1. First posted16 Oct 2008 (estimated)
  2. Study start12 Dec 2008
  3. Primary completion27 Jul 2017
  4. Study completion27 Jul 2017

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,825 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00773513
Sponsor's protocol ID
BH21260
Other IDs
2007-005129-31
Status last verified
Aug 2019
First submitted
15 Oct 2008
Last updated
20 Aug 2019
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

    PubMed 36791280

  • Locatelli F, Hannedouche T, Fishbane S, Morgan Z, Oguey D, White WB. Cardiovascular Safety and All-Cause Mortality of Methoxy Polyethylene Glycol-Epoetin Beta and Other Erythropoiesis-Stimulating Agents in Anemia of CKD: A Randomized Noninferiority Trial. Clin J Am Soc Nephrol. 2019 Dec 6;14(12):1701-1710. doi: 10.2215/CJN.01380219. Epub 2019 Aug 16.

    PubMed 31420350

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Darbepoetin Alfa, Epoetin Alfa and Epoetin Beta in people with Chronic Renal Anemia, run by Hoffmann-La Roche at 196 sites in 27 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 7 inclusion and 9 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: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 196 sites in Italy, United Kingdom, France, Germany, Poland and 22 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 15 Aug 2018). 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?

Time to Composite of All-Cause Mortality and Non-Fatal Cardiovascular Events (Myocardial Infarction, Stroke) Defined as Time Between First Dose of Study Medication and Date of Death or Non-Fatal Cardiovascular Events, Whichever Occurred First (time frame: Baseline up to approximately 8.5 years). 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 NCT00773513, 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 20 Aug 2019.

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