A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis.

This study has been terminated.
(Strategic decision unrelated to safety or efficacy)
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00454246
First received: March 29, 2007
Last updated: November 14, 2011
Last verified: November 2011
  Purpose

This study will assess the efficacy and safety of methoxy polyethylene glycol-epoetin beta (Mircera) in the maintenance of hemoglobin levels in patients who have previously received treatment with epoetin alfa or darbepoetin alfa, and who are transitioning from chronic kidney disease stage 4 through dialysis. Patients will be randomized either to receive Mircera or to remain on their existing therapy; the initial monthly dose of subcutaneous (sc) Mircera (120-360 micrograms) will be based on the average weekly dose of epoetin alfa or darbepoetin alfa administered in the week preceding the switch to Mircera. At the initiation of dialysis, patients in the Mircera group will receive monthly intravenous (iv) Mircera at a starting dose based on their previous (sc) dose, and those in the control group will receive weekly (iv) epoetin alfa. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.


Condition Intervention Phase
Anemia
Drug: methoxy polyethylene glycol-epoetin beta
Drug: epoetin alfa
Drug: darbepoetin alfa
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open Label Study of the Effect of Intravenous Mircera on Hemoglobin Control in Patients Transitioning From Chronic Kidney Disease Stage 4 Through Dialysis

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Patients Able to Maintain Hemoglobin (Hb) Within 10-12 g/dL [ Time Frame: 6-7 months post initiation of dialysis ] [ Designated as safety issue: No ]
    Efficacy analyses were not performed.


Secondary Outcome Measures:
  • Dose Adjustments [ Time Frame: 5 months post-randomization through onset of dialysis, and post-dialysis initiation through study end. ] [ Designated as safety issue: No ]
    Efficacy analyses were not performed.

  • Number of Participants Assessed for AEs and SAEs [ Time Frame: First dose of medication through 15 days post last dose (up to 8 months) ] [ Designated as safety issue: No ]
    The adverse events are captured in the adverse event and serious adverse event section of this database.


Enrollment: 111
Study Start Date: April 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: methoxy polyethylene glycol-epoetin beta

120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.

Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.

Drug: methoxy polyethylene glycol-epoetin beta
Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in a 1-mL prefilled syringe containing 0.3 mL or 0.6 mL solution. The methoxy polyethylene glycol-epoetin beta injectable solution was formulated in sodium phosphate, sodium sulfate, mannitol, methionine and poloxamer 188, pH 6.2 and did not contain any preservative. Participants received methoxy polyethylene glycol-epoetin beta subcutaneous once a month.
Other Name: Mircera
Active Comparator: Epoetin alfa

Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.

Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.

Drug: epoetin alfa
Standard of care as prescribed, per individual participant, subcutaneous once per week. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Active Comparator: Darbepoetin alfa

Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.

Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.

Drug: darbepoetin alfa
Standard of care as prescribed, per individual participant, darbepoetin alfa subcutaneous once every two weeks. Subcutaneous injections were to be administered in the same part of the body (ie, thigh,abdomen or arm) throughout the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • chronic kidney disease stage IV not requiring dialysis;
  • expected to initiate dialysis within 18 months;
  • 15<=Glomerular Filtration Rate (GFR)<=29.

Exclusion Criteria:

  • failing renal allograft in place;
  • acute or chronic bleeding within 8 weeks prior to screening;
  • transfusion of red blood cells within 8 weeks prior to screening;
  • poorly controlled hypertension;
  • immunosuppressive therapy in the 12 weeks prior to screening.
  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: NCT00454246

  Show 78 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: NCT00454246     History of Changes
Other Study ID Numbers: ML20337
Study First Received: March 29, 2007
Results First Received: March 29, 2011
Last Updated: November 14, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014