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: October 6, 2014
Last verified: October 2014
  Purpose

This 2 arm safety study will compare the outcome with respect to a composite end point of all-cause mortality and non-fatal cardiovascular events (myocardial inf arction, stroke) in chronic kidney disease (CKD) patients either on dialysis or not receiving renal replacement therapy under treatment with Mircera or referenc e ESAs. Patients will be randomized to receive intravenous or subcutaneous Mirce ra at the following doses: for patients not already receiving ESA treatment Mirc era will be administered at a starting dose of 0.6 micrograms/kg every 2 weeks; for patients receiving maintenance ESA treatment, intravenous or subcutaneous Mi rcera will be administered at an initial monthly dose of 120, 200 or 360 microgr ams depending on the weekly dose of ESA received prior to first Mircera administ ration. 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 ]

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, 1708
Buenos Aires, Argentina, B1650IHM
Buenos Aires, Argentina, 1640
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, 05001-000
Sao Paulo, SP, Brazil, 01323-900
Sao Paulo, SP, Brazil, 05403-000
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, 20162
Milano, Lombardia, Italy, 20153
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, 191104
St.Petersburg, Russian Federation, 195257
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, BT9 7LJ
Belfast, United Kingdom, BT16 1RH
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: October 6, 2014
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 October 23, 2014