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 currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00773513
First received: October 15, 2008
Last updated: July 1, 2015
Last verified: July 2015
  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:


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 ]

Estimated Enrollment: 2800
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

Contacts
Contact: Reference Study ID Number: BH21260 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Hide Study Locations
Locations
Argentina
Active, not recruiting
Buenos Aires, Argentina, 1640
Active, not recruiting
Buenos Aires, Argentina, 1708
Active, not recruiting
Buenos Aires, Argentina, B1650IHM
Active, not recruiting
Caba, Argentina, 1425
Australia, New South Wales
Active, not recruiting
Gosford, New South Wales, Australia, 2250
Australia, Queensland
Active, not recruiting
Cairns, Queensland, Australia, 4870
Terminated
Southport, Queensland, Australia, 4215
Australia, South Australia
Active, not recruiting
Adelaide, South Australia, Australia, SA 5000
Australia, Tasmania
Active, not recruiting
Launceston, Tasmania, Australia, 7250
Australia, Victoria
Active, not recruiting
Clayton, Victoria, Australia, 3186
Australia, Western Australia
Active, not recruiting
Perth, Western Australia, Australia, 6847
Belgium
Active, not recruiting
Bruxelles, Belgium, 1090
Active, not recruiting
Gent, Belgium, 9000
Active, not recruiting
Hasselt, Belgium, 3500
Active, not recruiting
Leuven, Belgium, 3000
Active, not recruiting
Roeselare, Belgium, 8800
Brazil
Active, not recruiting
Juiz de Fora, MG, Brazil, 36036-330
Active, not recruiting
Curitiba, PR, Brazil, 80050-350
Active, not recruiting
Rio de Janeiro, RJ, Brazil, 20551-030
Active, not recruiting
Porto Alegre, RS, Brazil, 90020-090
Active, not recruiting
Porto Alegre, RS, Brazil, 90610-000
Terminated
Sao Paulo, SP, Brazil, 05403-000
Active, not recruiting
Sao Paulo, SP, Brazil, 04038-002
Active, not recruiting
Sao Paulo, SP, Brazil, 05001-000
Active, not recruiting
Sao Paulo, SP, Brazil, 01323-900
Active, not recruiting
Sorocaba, SP, Brazil, 18040-335
Croatia
Active, not recruiting
Karlovac, Croatia, 47000
Active, not recruiting
Osijek, Croatia, 31000
Active, not recruiting
Rijeka, Croatia, 51000
Completed
Slavonski Brod, Croatia, 35000
Active, not recruiting
Split, Croatia, 21000
Active, not recruiting
Zadar, Croatia, 23000
Active, not recruiting
Zagreb, Croatia, 10000
Czech Republic
Active, not recruiting
Hradec Kralove, Czech Republic, 500 05
Active, not recruiting
Ostrava, Czech Republic, 708 52
Active, not recruiting
Praha, Czech Republic, 140 21
Active, not recruiting
Praha 6, Czech Republic, 169 00
France
Active, not recruiting
Annonay, France, 07103
Active, not recruiting
Bordeaux, France, 33076
Active, not recruiting
Boulogne, France, 62321
Active, not recruiting
Brest, France, 29609
Active, not recruiting
Colmar, France, 68024
Active, not recruiting
La Garenne-Colombes, France, 92250
Active, not recruiting
Limoges, France, 87042
Active, not recruiting
Lyon, France, 69008
Active, not recruiting
Lyon, France, 69437
Active, not recruiting
Macon, France, 71018
Completed
Nantes, France, 44035
Active, not recruiting
Nimes, France, 30059
Active, not recruiting
Paris, France, 75014
Active, not recruiting
Saint Herblain, France, 44805
Active, not recruiting
Salouel, France, 80480
Active, not recruiting
Strasbourg, France, 67091
Active, not recruiting
Toulouse, France, 31059
Active, not recruiting
Valenciennes, France, 59322
Germany
Active, not recruiting
Alsfeld, Germany, 36304
Terminated
Bad Hersfeld, Germany, 36251
Active, not recruiting
Bonn, Germany, 53127
Active, not recruiting
Demmin, Germany, 17109
Active, not recruiting
Düsseldorf, Germany, 40225
Active, not recruiting
Düsseldorf, Germany, 40210
Active, not recruiting
Erlangen, Germany, 91054
Active, not recruiting
Giessen, Germany, 35392
Active, not recruiting
Hamburg, Germany, 22297
Terminated
Hann. Münden, Germany, 34346
Completed
Heidelberg, Germany, 69120
Active, not recruiting
Homburg/Saar, Germany, 66424
Active, not recruiting
Kiel, Germany, 24105
Active, not recruiting
München, Germany, 80804
Active, not recruiting
Oberschleissheim, Germany, 85764
Active, not recruiting
Rostock, Germany, 18107
Active, not recruiting
Schwandorf, Germany, 92421
Active, not recruiting
Stuttgart, Germany, 70376
Greece
Active, not recruiting
Alexandroupolis, Greece, 68100
Active, not recruiting
Athens, Greece, 115 27
Active, not recruiting
Ioannina, Greece, 455 00
Active, not recruiting
Larissa, Greece, 41 110
Active, not recruiting
Thessaloniki, Greece, 546 42
Israel
Active, not recruiting
Petach Tikva, Israel, 49100
Active, not recruiting
Petah Tikva, Israel, 4937211
Active, not recruiting
Ramat-Gan, Israel, 52621
Active, not recruiting
Tel Aviv, Israel, 6423906
Active, not recruiting
Zrifin, Israel, 70300
Italy
Active, not recruiting
Carpi, Emilia-Romagna, Italy, 41012
Active, not recruiting
Imola, Emilia-Romagna, Italy, 40026
Active, not recruiting
Modena, Emilia-Romagna, Italy, 41100
Active, not recruiting
Parma, Emilia-Romagna, Italy, 43100
Active, not recruiting
Piacenza, Emilia-Romagna, Italy, 29100
Terminated
Ravenna, Emilia-Romagna, Italy, 48100
Active, not recruiting
Reggio Emilia, Emilia-Romagna, Italy, 42100
Active, not recruiting
Roma, Lazio, Italy, 00100
Active, not recruiting
Genova, Liguria, Italy, 16132
Completed
Bollate, Lombardia, Italy, 20021
Active, not recruiting
Lecco, Lombardia, Italy, 23900
Terminated
Milano, Lombardia, Italy, 20122
Active, not recruiting
Milano, Lombardia, Italy, 20153
Active, not recruiting
Milano, Lombardia, Italy, 20162
Active, not recruiting
Pavia, Lombardia, Italy, 27100
Active, not recruiting
S Fermo Della Battaglia, Lombardia, Italy, 22020
Active, not recruiting
Pesaro, Marche, Italy, 61100
Active, not recruiting
Acireale, Sicilia, Italy, 95024
Active, not recruiting
Catania, Sicilia, Italy, 95126
Active, not recruiting
Messina, Sicilia, Italy, 98147
Active, not recruiting
Lodi, Toscana, Italy, 26900
Active, not recruiting
Prato, Toscana, Italy, 50047
Terminated
Castelfranco, Veneto, Italy, 31033
Active, not recruiting
Cona (FE), Veneto, Italy, 44124
Active, not recruiting
Conegliano, Veneto, Italy, 31015
Active, not recruiting
Padova, Veneto, Italy, 35128
Active, not recruiting
Rovigo, Veneto, Italy, 45100
Completed
Treviso, Veneto, Italy, 31100
Korea, Republic of
Completed
Seoul, Korea, Republic of, 135-710
Active, not recruiting
Seoul, Korea, Republic of, 110-744
Lithuania
Active, not recruiting
Kaunas, Lithuania, 50009
Active, not recruiting
Vilnius, Lithuania, 08661
Malaysia
Active, not recruiting
Kuala Lumpur, Malaysia, 50603
Active, not recruiting
Kuala Lumpur, Malaysia, 50586
Active, not recruiting
Selangor, Malaysia, 68100
Mexico
Active, not recruiting
Cuernavaca, Mexico, 62448
Panama
Active, not recruiting
Panama, Panama, 0834-02723
Philippines
Active, not recruiting
CEBU City, Philippines, 6000
Active, not recruiting
Quezon, Philippines, 1100
Poland
Active, not recruiting
Bydgoszcz, Poland, 85-094
Active, not recruiting
Ciechanow, Poland, 06-400
Active, not recruiting
Dabrowa Tarnowska, Poland, 33-200
Completed
Gorlice, Poland, 38-300
Active, not recruiting
Jaslo, Poland, 38-200
Terminated
Limanowa, Poland, 34-600
Active, not recruiting
Pabianice, Poland, 95-200
Active, not recruiting
Poznan, Poland, 61-485
Active, not recruiting
Rzeszow, Poland, 35-055
Active, not recruiting
Sandomierz, Poland, 27-600
Completed
Skierniewice, Poland, 96-100
Active, not recruiting
Stalowa Wola, Poland, 37-450
Active, not recruiting
Walbrzych, Poland, 58-309
Active, not recruiting
Zamosc, Poland, 22-400
Russian Federation
Active, not recruiting
Saint-Petersburg, Russian Federation, 195067
Active, not recruiting
St Petersburg, Russian Federation, 197089
Active, not recruiting
St.Petersburg, Russian Federation, 191104
Active, not recruiting
St.Petersburg, Russian Federation, 195257
Serbia
Active, not recruiting
Belgrade, Serbia, 11000
Active, not recruiting
NIS, Serbia, 18000
Active, not recruiting
Novi Sad, Serbia, 21000
Singapore
Active, not recruiting
Singapore, Singapore, 308433
Active, not recruiting
Singapore, Singapore, 169608
Active, not recruiting
Singapore, Singapore, 119074
Spain
Active, not recruiting
Vitoria, Alava, Spain, 01009
Active, not recruiting
Almería, Almeria, Spain, 04009
Active, not recruiting
Leganes, Madrid, Spain, 28911
Active, not recruiting
San Sebastian de los Reyes, Madrid, Spain, 28702
Active, not recruiting
Pamplona, Navarra, Spain, 31008
Active, not recruiting
Barakaldo, Vizcaya, Spain, 48903
Completed
Bilbao, Vizcaya, Spain, 48013
Active, not recruiting
Galdakao, Vizcaya, Spain, 48960
Terminated
Barcelona, Spain, 08003
Active, not recruiting
Granada, Spain, 18012
Active, not recruiting
Jaen, Spain, 23007
Terminated
Madrid, Spain, 28040
Active, not recruiting
Madrid, Spain, 28034
Sweden
Completed
Danderyd, Sweden, 18288
Active, not recruiting
Eskilstuna, Sweden, 63188
Active, not recruiting
Uppsala, Sweden, 75185
Taiwan
Recruiting
Kaohsiung, Taiwan, 833
Active, not recruiting
Taipei, Taiwan, 100
Thailand
Active, not recruiting
Bangkok, Thailand, 10310
Active, not recruiting
Chiang Mai, Thailand, 50200
Active, not recruiting
Phitsanulok, Thailand, 65000
Turkey
Active, not recruiting
Adana, Turkey, 01100
Active, not recruiting
Ankara, Turkey, 06490
Active, not recruiting
Malatya, Turkey, 44300
United Kingdom
Active, not recruiting
Belfast, United Kingdom, BT16 1RH
Active, not recruiting
Belfast, United Kingdom, BT9 7LJ
Completed
Bradford, United Kingdom, BD5 0NA
Active, not recruiting
Cardiff, United Kingdom, CF14 4XW
Active, not recruiting
Carshalton, United Kingdom, SM5 1AA
Active, not recruiting
Coventry, United Kingdom, CV2 2DX
Active, not recruiting
Dorchester, United Kingdom, DT1 1TS
Active, not recruiting
Exeter, United Kingdom, EX2 5DW
Active, not recruiting
Hull, United Kingdom, HU3 2JZ
Active, not recruiting
Ipswich, United Kingdom, IP4 5PD
Active, not recruiting
Leeds, United Kingdom, LS9 7TF
Active, not recruiting
Leicester, United Kingdom, LE5 4PW
Active, not recruiting
London, United Kingdom, NW3 2PF
Active, not recruiting
Middlesborough, United Kingdom, TS4 3BW
Active, not recruiting
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Active, not recruiting
Oxford, United Kingdom, OX3 7LJ
Completed
Plymouth, United Kingdom, PL6 8DH
Active, not recruiting
Preston, United Kingdom, PR2 9HT
Active, not recruiting
Salford, United Kingdom, M6 8HD
Active, not recruiting
Shrewsbury, United Kingdom, SY3 8XQ
Active, not recruiting
Swansea, United Kingdom, SA6 6NL
Active, not recruiting
Truro, United Kingdom, TR1 3LJ
Active, not recruiting
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: July 1, 2015
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Additional relevant MeSH terms:
Darbepoetin alfa
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 01, 2015