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:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00773513
First received: October 15, 2008
Last updated: July 1, 2016
Last verified: July 2016
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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: | 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 (Adult, Senior) |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00773513
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00773513
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Locations
| Argentina | |
| Buenos Aires, Argentina, 1640 | |
| Buenos Aires, Argentina, 1708 | |
| Buenos Aires, Argentina, B1650IHM | |
| 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, 5000 | |
| Australia, Tasmania | |
| Launceston, Tasmania, Australia, 7250 | |
| Australia, Victoria | |
| Clayton, Victoria, Australia, 3186 | |
| Australia, Western Australia | |
| Perth, Western Australia, Australia, 6847 | |
| Belgium | |
| Brussel, Belgium, 1090 | |
| Gent, Belgium, 9000 | |
| Hasselt, Belgium, 3500 | |
| Leuven, Belgium, 3000 | |
| Roeselare, Belgium, 8800 | |
| Brazil | |
| Juiz de Fora, MG, Brazil, 36036-330 | |
| 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, 01323-900 | |
| Sao Paulo, SP, Brazil, 04038-002 | |
| Sao Paulo, SP, Brazil, 05001-000 | |
| Sao Paulo, SP, Brazil, 05403-000 | |
| 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 6, Czech Republic, 169 00 | |
| Praha, Czech Republic, 140 21 | |
| 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, 69008 | |
| Lyon, France, 69437 | |
| Macon, France, 71018 | |
| Nantes, France, 44035 | |
| Nimes, France, 30059 | |
| Paris, France, 75014 | |
| 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, 03080 | |
| Seoul, Korea, Republic of, 06351 | |
| Lithuania | |
| Kaunas, Lithuania, 50009 | |
| Vilnius, Lithuania, 08661 | |
| Malaysia | |
| Kuala Lumpur, Malaysia, 50586 | |
| Kuala Lumpur, Malaysia, 50603 | |
| Selangor, Malaysia, 68100 | |
| Mexico | |
| Cuernavaca, Mexico, 62448 | |
| Panama | |
| Panama, Panama, 0834-02723 | |
| 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, 117599 | |
| Singapore, Singapore, 169608 | |
| 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
| 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, 2016 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Additional relevant MeSH terms:
|
Darbepoetin alfa Epoetin Alfa Hematinics |
ClinicalTrials.gov processed this record on September 26, 2016