A Study of Subcutaneous Mircera for the Treatment of Anemia in Peritoneal Dialysis Patients.

This study has been terminated.
(Strategic decision unrelated to safety or efficacy)
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00442416
First received: March 1, 2007
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This 2 arm study will compare the efficacy of monthly Mircera and epoetin alfa i n peritoneal dialysis patients who self-inject at home or receive in-centre inje ctions. The safety of subcutaneous (sc) Mircera and injection site reactions and patient satisfaction will also be assessed. Eligible patients will be randomize d either to receive monthly sc injections of Mircera (and will be switched from sc epoetin alfa) at a starting dose of 120-360 micrograms, or to remain on stand ard of care sc epoetin alfa. Dose adjustments will be permitted to reach/maintai n a hemoglobin level of 10-12g/dL. The anticipated time on study treatment is 3- 12 months, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Anemia
Drug: Epoetin alfa
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
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 to Compare the Effect of Monthly Injections of Mircera Versus Epoetin Alfa on Hemoglobin Levels in Peritoneal Dialysis Patients Who Self-inject or Receive In-center Injections

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in Hb concentration between baseline and average during evaluation period [ Time Frame: Months 7-9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vital signs, AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: February 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
120-360 micrograms sc monthly, starting dose
Active Comparator: 2 Drug: Epoetin alfa
As prescribed, sc

  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 V;
  • on peritoneal dialysis for 3 months prior to screening;
  • on epoetin alfa sc >=3 months prior to screening.

Exclusion Criteria:

  • patients expecting to change dialysis modality over course of study;
  • patients hospitalized during previous 3 months for any clinically significant condition;
  • active malignancy;
  • bleeding episode necessitating transfusion, or overt gastrointestinal bleeding within 3 months prior to screening;
  • transfusion of red blood cells within 3 months 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: NCT00442416

  Show 66 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: NCT00442416     History of Changes
Other Study ID Numbers: ML20338
Study First Received: March 1, 2007
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 16, 2014