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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

October 15, 2008
November 1, 2016
December 2008
July 2017   (final data collection date for primary outcome measure)
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 ]
Time to composite of all cause mortality and non-fatal cardiovascular events (myocardial infarctions, stroke). [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00773513 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
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)
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.
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Renal Anemia
  • 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®
  • 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.
    Interventions:
    • Drug: Darbepoetin Alfa
    • Drug: Epoetin Alfa
    • Drug: Epoetin Beta
    • Drug: methoxy polyethylene glycol-epoetin beta
  • 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.
    Interventions:
    • Drug: Darbepoetin Alfa
    • Drug: Epoetin Alfa
    • Drug: methoxy polyethylene glycol-epoetin beta
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2828
July 2017
July 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Belgium,   Brazil,   Croatia,   Czech Republic,   France,   Germany,   Greece,   Israel,   Italy,   Korea, Republic of,   Lithuania,   Malaysia,   Mexico,   Panama,   Philippines,   Poland,   Russian Federation,   Serbia,   Singapore,   Spain,   Sweden,   Taiwan,   Thailand,   Turkey,   United Kingdom
 
NCT00773513
BH21260, 2007-005129-31
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP