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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00442416
• Other study ID #: ML20338
• Status: Terminated
• Phase: Phase 3
• First received: March 1, 2007
• Last updated: November 2, 2015
• Start date: February 2007
• Est. completion date: April 2008

Study information

• Verified date: November 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This 2 arm study will compare the efficacy of monthly Mircera and epoetin alfa in peritoneal dialysis patients who self-inject at home or receive in-centre injections. The safety of subcutaneous (sc) Mircera and injection site reactions and patient satisfaction will also be assessed. Eligible patients will be randomized 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 standard of care sc epoetin alfa. Dose adjustments will be permitted to reach/maintain 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• Epoetin alfa
As prescribed, sc
• methoxy polyethylene glycol-epoetin beta [Mircera]
120-360 micrograms sc monthly, starting dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hb concentration between baseline and average during evaluation period		Months 7-9	No
Secondary	Vital signs, AEs, laboratory parameters		Throughout study	Yes