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: September 22, 2014
Last verified: September 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

  Show 193 Study Locations
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: September 22, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Additional relevant MeSH terms:
Darbepoetin alfa
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014