A Study of All-Cause Mortality and Cardiovascular Morbidity in CKD Patients on Dialysis and Those Not on Renal Replacement Therapy Receiving Mircera or Reference ESAs.

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00773513

First received: October 15, 2008

Last updated: March 2, 2015

Last verified: March 2015

History of Changes

Purpose

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 chronic kidney disease (CKD) patients either on dialysis or not receiving renal replacement therapy under treatment with Mircera or reference ESAs. Patients will be randomized to receive intravenous or subcutaneous Mircera at the following doses: for patients not already receiving ESA treatment Mircera will be administered at a starting dose of 0.6 micrograms/kg every 2 weeks; for patients receiving maintenance ESA treatment, intravenous or subcutaneous Mircera will be administered at an initial monthly dose of 120, 200 or 360 micrograms depending on the weekly dose of ESA received prior to first Mircera administration. Patients randomized to reference ESA treatment will receive intravenous or subcutaneous ESAs in accordance with their prescribed dosing information. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.

Condition	Intervention	Phase
Anemia	Drug: ESAs (darbepoetin alfa, epoetin alfa or epoetin beta) Drug: methoxy polyethylene glycol-epoetin beta [Mircera]	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Open Label 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.

Resource links provided by NLM:

MedlinePlus related topics: Dialysis

Drug Information available for: Polyethylene Erythropoietin Polyethylene glycol Epoetin Alfa

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Time to composite of all cause mortality and non-fatal cardiovascular events (myocardial infarctions, stroke). [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to the individual components of the composite endpoint: time to death, time to non-fatal cardiovascular events (MI or stroke), time to MI and time to stroke. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Incidence of adverse events, and serious adverse events; vital signs, laboratory parameters, ECG. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]


Enrollment:	2828
Study Start Date:	December 2008
Estimated Study Completion Date:	November 2019
Estimated Primary Completion Date:	November 2019 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] 0.6 micrograms/kg iv every 2 weeks in patients not already receiving ESAs Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Starting dose 120, 200 or 360 micrograms monthly in patients receiving maintenance ESA therapy.
Active Comparator: 2	Drug: ESAs (darbepoetin alfa, epoetin alfa or epoetin beta) As prescribed

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

male or female patients >18 years of age with symptomatic anemia associated with CKD;
patients with renal anemia (Hb <11.0g/dL) not treated with an ESA or on maintenance ESA therapy;
if receiving hemodialysis or peritoneal dialysis, with the same mode of dialysis for at least 3 months before screening, and continuous intravenous or subcutaneous maintenance therapy with ESAs at the same dosing interval for at least 2 months before screening;
Hb concentration between 10 and 12g/dL;
adequate iron status (ferritin >=100micrograms/L or TSAT >=20%.

Exclusion Criteria:

uncontrolled hypertension;
history of hemoglobinopathy;
anemia due to hemolysis;
pure red cell aplasia.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773513

Hide Study Locations

Locations


Argentina

Buenos Aires, Argentina, 1640

Buenos Aires, Argentina, B1650IHM

Buenos Aires, Argentina, 1708

Caba, Argentina, 1425
Australia, New South Wales

Gosford, New South Wales, Australia, 2250
Australia, Queensland

Cairns, Queensland, Australia, 4870

Southport, Queensland, Australia, 4215
Australia, South Australia

Adelaide, South Australia, Australia, SA 5000
Australia, Tasmania

Launceston, Tasmania, Australia, 7250
Australia, Victoria

Clayton, Victoria, Australia, 3186
Australia, Western Australia

Perth, Western Australia, Australia, 6847
Belgium

Bruxelles, Belgium, 1090

Gent, Belgium, 9000

Hasselt, Belgium, 3500

Leuven, Belgium, 3000

Roeselare, Belgium, 8800
Brazil

Juiz de Fora, MG, Brazil, 36010-570

Curitiba, PR, Brazil, 80050-350

Rio de Janeiro, RJ, Brazil, 20551-030

Porto Alegre, RS, Brazil, 90020-090

Porto Alegre, RS, Brazil, 90610-000

Sao Paulo, SP, Brazil, 05403-000

Sao Paulo, SP, Brazil, 01323-900

Sao Paulo, SP, Brazil, 05001-000

Sao Paulo, SP, Brazil, 04038-002

Sorocaba, SP, Brazil, 18040-335
Croatia

Karlovac, Croatia, 47000

Osijek, Croatia, 31000

Rijeka, Croatia, 51000

Slavonski Brod, Croatia, 35000

Split, Croatia, 21000

Zadar, Croatia, 23000

Zagreb, Croatia, 10000
Czech Republic

Hradec Kralove, Czech Republic, 500 05

Ostrava, Czech Republic, 708 52

Praha, Czech Republic, 140 21

Praha 6, Czech Republic, 169 00
France

Annonay, France, 07103

Bordeaux, France, 33076

Boulogne, France, 62321

Brest, France, 29609

Colmar, France, 68024

La Garenne-Colombes, France, 92250

Limoges, France, 87042

Lyon, France, 69437

Lyon, France, 69008

Macon, France, 71018

Nantes, France, 44035

Nimes, France, 30059

Paris, France, 75015

Saint Herblain, France, 44805

Salouel, France, 80480

Strasbourg, France, 67091

Toulouse, France, 31059

Valenciennes, France, 59322
Germany

Alsfeld, Germany, 36304

Bad Hersfeld, Germany, 36251

Bonn, Germany, 53127

Demmin, Germany, 17109

Düsseldorf, Germany, 40210

Düsseldorf, Germany, 40225

Erlangen, Germany, 91054

Giessen, Germany, 35392

Hamburg, Germany, 22297

Hann. Münden, Germany, 34346

Heidelberg, Germany, 69120

Homburg/Saar, Germany, 66424

Kiel, Germany, 24105

München, Germany, 80804

Oberschleissheim, Germany, 85764

Rostock, Germany, 18107

Schwandorf, Germany, 92421

Stuttgart, Germany, 70376
Greece

Alexandroupolis, Greece, 68100

Athens, Greece, 115 27

Ioannina, Greece, 455 00

Larissa, Greece, 41 110

Thessaloniki, Greece, 546 42
Israel

Petach Tikva, Israel, 49100

Petah Tikva, Israel, 4937211

Ramat-Gan, Israel, 52621

Tel Aviv, Israel, 6423906

Zrifin, Israel, 70300
Italy

Carpi, Emilia-Romagna, Italy, 41012

Imola, Emilia-Romagna, Italy, 40026

Modena, Emilia-Romagna, Italy, 41100

Parma, Emilia-Romagna, Italy, 43100

Piacenza, Emilia-Romagna, Italy, 29100

Ravenna, Emilia-Romagna, Italy, 48100

Reggio Emilia, Emilia-Romagna, Italy, 42100

Roma, Lazio, Italy, 00100

Genova, Liguria, Italy, 16132

Bollate, Lombardia, Italy, 20021

Lecco, Lombardia, Italy, 23900

Milano, Lombardia, Italy, 20122

Milano, Lombardia, Italy, 20153

Milano, Lombardia, Italy, 20162

Pavia, Lombardia, Italy, 27100

S Fermo Della Battaglia, Lombardia, Italy, 22020

Pesaro, Marche, Italy, 61100

Acireale, Sicilia, Italy, 95024

Catania, Sicilia, Italy, 95126

Messina, Sicilia, Italy, 98147

Lodi, Toscana, Italy, 26900

Prato, Toscana, Italy, 50047

Castelfranco, Veneto, Italy, 31033

Cona (FE), Veneto, Italy, 44124

Conegliano, Veneto, Italy, 31015

Padova, Veneto, Italy, 35128

Rovigo, Veneto, Italy, 45100

Treviso, Veneto, Italy, 31100
Korea, Republic of

Seoul, Korea, Republic of, 135-710

Seoul, Korea, Republic of, 110-744
Lithuania

Kaunas, Lithuania, 50009

Vilnius, Lithuania, 08661
Malaysia

Kuala Lumpur, Malaysia, 50603

Kuala Lumpur, Malaysia, 50586

Selangor, Malaysia, 68100
Mexico

Cuernavaca, Mexico, 62448
Panama

Panama, Panama
Philippines

CEBU City, Philippines, 6000

Quezon, Philippines, 1100
Poland

Bydgoszcz, Poland, 85-094

Ciechanow, Poland, 06-400

Dabrowa Tarnowska, Poland, 33-200

Gorlice, Poland, 38-300

Jaslo, Poland, 38-200

Limanowa, Poland, 34-600

Pabianice, Poland, 95-200

Poznan, Poland, 61-485

Rzeszow, Poland, 35-055

Sandomierz, Poland, 27-600

Skierniewice, Poland, 96-100

Stalowa Wola, Poland, 37-450

Walbrzych, Poland, 58-309

Zamosc, Poland, 22-400
Russian Federation

Saint-Petersburg, Russian Federation, 195067

St Petersburg, Russian Federation, 197089

St.Petersburg, Russian Federation, 195257

St.Petersburg, Russian Federation, 191104
Serbia

Belgrade, Serbia, 11000

NIS, Serbia, 18000

Novi Sad, Serbia, 21000
Singapore

Singapore, Singapore, 169608

Singapore, Singapore, 119074

Singapore, Singapore, 308433
Spain

Vitoria, Alava, Spain, 01009

Almería, Almeria, Spain, 04009

Leganes, Madrid, Spain, 28911

San Sebastian de los Reyes, Madrid, Spain, 28702

Pamplona, Navarra, Spain, 31008

Barakaldo, Vizcaya, Spain, 48903

Bilbao, Vizcaya, Spain, 48013

Galdakao, Vizcaya, Spain, 48960

Barcelona, Spain, 08003

Granada, Spain, 18012

Jaen, Spain, 23007

Madrid, Spain, 28034

Madrid, Spain, 28040
Sweden

Danderyd, Sweden, 18288

Eskilstuna, Sweden, 63188

Uppsala, Sweden, 75185
Taiwan

Kaohsiung, Taiwan, 833

Taipei, Taiwan, 100
Thailand

Bangkok, Thailand, 10310

Chiang Mai, Thailand, 50200

Phitsanulok, Thailand, 65000
Turkey

Adana, Turkey, 01100

Ankara, Turkey, 06490

Malatya, Turkey, 44300
United Kingdom

Belfast, United Kingdom, BT16 1RH

Belfast, United Kingdom, BT9 7LJ

Bradford, United Kingdom, BD5 0NA

Cardiff, United Kingdom, CF14 4XW

Carshalton, United Kingdom, SM5 1AA

Coventry, United Kingdom, CV2 2DX

Dorchester, United Kingdom, DT1 1TS

Exeter, United Kingdom, EX2 5DW

Hull, United Kingdom, HU3 2JZ

Ipswich, United Kingdom, IP4 5PD

Leeds, United Kingdom, LS9 7TF

Leicester, United Kingdom, LE5 4PW

London, United Kingdom, NW3 2PF

Middlesborough, United Kingdom, TS4 3BW

Newcastle Upon Tyne, United Kingdom, NE7 7DN

Oxford, United Kingdom, OX3 7LJ

Plymouth, United Kingdom, PL6 8DH

Preston, United Kingdom, PR2 9HT

Salford, United Kingdom, M6 8HD

Shrewsbury, United Kingdom, SY3 8XQ

Swansea, United Kingdom, SA6 6NL

Truro, United Kingdom, TR1 3LJ

West Sussex, United Kingdom, BN11 2DH

Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche

More Information

No publications provided


Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00773513 History of Changes
Other Study ID Numbers:	BH21260, 2007-005129-31
Study First Received:	October 15, 2008
Last Updated:	March 2, 2015
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Additional relevant MeSH terms:


Epoetin alfa Hematinics Hematologic Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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