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: April 22, 2014
Last verified: April 2014

October 15, 2008
April 22, 2014
December 2008
November 2019   (final data collection date for primary outcome measure)
Time to composite of all cause mortality and non-fatal cardiovascular events (myocardial infarctions, stroke). [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00773513 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Anemia
  • 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.
  • Drug: ESAs (darbepoetin alfa, epoetin alfa or epoetin beta)
    As prescribed
  • Experimental: 1
    Interventions:
    • Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
    • Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
  • Active Comparator: 2
    Intervention: Drug: ESAs (darbepoetin alfa, epoetin alfa or 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
November 2019
November 2019   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
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
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2014

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