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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)

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: November 1, 2016
Last verified: November 2016
  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 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.

Condition Intervention Phase
Chronic Renal Anemia
Drug: Darbepoetin Alfa
Drug: Epoetin Alfa
Drug: Epoetin Beta
Drug: methoxy polyethylene glycol-epoetin beta
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, 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.

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 Infarction, Stroke) Defined as Time Between First Dose of Study Medication and Date of Death or Non-Fatal Cardiovascular Events, Whatever Occurs First [ Time Frame: Event driven (Baseline up to approximately 10 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Death [ Time Frame: Event driven (Baseline up to approximately 10 years) ] [ Designated as safety issue: No ]
  • Time to Non-Fatal Cardiovascular Events (Myocardial Infarction or Stroke, Whichever Occurs First) [ Time Frame: Event driven (Baseline up to approximately 10 years) ] [ Designated as safety issue: No ]
  • Time to Non-Fatal Myocardial Infarction [ Time Frame: Event driven (Baseline up to approximately 10 years) ] [ Designated as safety issue: No ]
  • Time to Non-Fatal Stroke [ Time Frame: Event driven (Baseline up to approximately 10 years) ] [ Designated as safety issue: No ]
  • Percentage of Participants With Anti-Erythropoietin Antibody-Mediated Pure Red Cell Aplasia (PRCA) [ Time Frame: Baseline up to approximately 10 years ] [ Designated as safety issue: No ]
  • Percentage of Participants With Gastrointestinal Bleeding [ Time Frame: Event driven (Baseline up to approximately 10 years) ] [ Designated as safety issue: No ]
  • Percentage of Participants With Thromboembolic Events [ Time Frame: Event driven (Baseline up to approximately 10 years) ] [ Designated as safety issue: No ]

Enrollment: 2828
Study Start Date: December 2008
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Erythropoiesis Stimulating Agents
Participants 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.
Drug: Darbepoetin Alfa
Darbepoetin alfa will be administered as per approved label.
Other Name: Aranesp®, Nespo®, Aranest®
Drug: Epoetin Alfa
Epoetin alfa will be administered as per approved label.
Other Name: Eprex®, Epogen®, Epopen®, Erypo®
Drug: Epoetin Beta
Epoetin beta will be administered as per approved label.
Other Name: Neorecormon®, Recormon®
Drug: methoxy polyethylene glycol-epoetin beta
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)
Other Name: Mircera®
Experimental: Methoxy Polyethylene Glycol-Epoetin Beta
Participants 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.
Drug: Darbepoetin Alfa
Darbepoetin alfa will be administered as per approved label.
Other Name: Aranesp®, Nespo®, Aranest®
Drug: Epoetin Alfa
Epoetin alfa will be administered as per approved label.
Other Name: Eprex®, Epogen®, Epopen®, Erypo®
Drug: methoxy polyethylene glycol-epoetin beta
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)
Other Name: Mircera®

  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 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

Exclusion Criteria:

  • 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
  • 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
  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, 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, Fed. Territory of Kuala Lumpur, Malaysia, 50603
Kuala Lumpur, Malaysia, 50586
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: November 1, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Epoetin Alfa
Darbepoetin alfa
Hematinics

ClinicalTrials.gov processed this record on December 02, 2016