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

Anemia Clinical Trial

Official title:

An Open Label Study of the Effect of Intravenous Mircera on Hemoglobin Levels in Anemic Patients With Chronic Kidney Disease Who Are on Dialysis, and Who Have Previously Received Epoetin Alfa or Beta or Darbepoetin Alfa Treatment.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00413894
• Other study ID #: ML20572
• Status: Completed
• Phase: Phase 3
• First received: December 19, 2006
• Last updated: January 17, 2016
• Start date: March 2007
• Est. completion date: October 2008

Study information

• Verified date: January 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

This single arm study will assess the efficacy and safety of intravenous Mircera, administered with pre-filled syringes, for the treatment of anemia in patients with chronic kidney disease who are on dialysis, and who have previously received treatment with epoetin alfa or beta or darbepoetin alfa. Patients will receive monthly intravenous injections of Mircera, with the starting dose derived from the dose of epoetin alfa or beta or darbepoetin they were receiving in the week preceding study start. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• chronic renal anemia;

• longterm hemodialysis for >=12 weeks before screening;

• baseline Hb between 10 and 13g/dL;

• iv or sc maintenance epoetin alfa or beta or darbepoetin alfa therapy with same dosing interval for >=4 weeks before screening.

Exclusion Criteria:

• acute or chronic bleeding within 8 weeks prior to screening;

• transfusion of red blood cells within 8 weeks prior to screening;

• poorly controlled hypertension necessitating interruption of erythropoetin treatment in previous 6 months;

• previous treatment with Mircera.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• methoxy polyethylene glycol-epoetin beta [Mircera]
iv monthly, with starting dose based on previous dose of epoetin alfa or beta or darbepoetin alfa

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Hb Levels Within 11.0-12.5 Grams Per Deciliter (g/dL) During Evaluation Phase		Visits 8 to 10 (Months 6 to 8)	No
Primary	Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Evaluation Phase		Visits 8 to 10 (Months 6 to 8)	No
Primary	Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modifications During Evaluation Phase	Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.	Visits 8 to 10 (Months 6 to 8)	No
Primary	Percentage of Participants With Hemoglobin Levels Within 10.0-13.0 g/dL by Dose Modification During Evaluation Phase	Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.	Visits 8 to 10 (Months 6 to 8)	No
Secondary	Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL During Screening Phase		Visits 1 to 2 (Months -2 to -1)	No
Secondary	Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Screening Phase		Visits 1 to 2 (Months -2 to -1)	No
Secondary	Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modification During Screening Phase	Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.	Visits 1 to 2 (Months -2 to -1)	No
Secondary	Percentage of Participants With HbLevels Within 10.0-13.0 g/dL by Dose Modification During Screening Phase	Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.	Visits 1 to 2 (Months -2 to -1)	No
Secondary	Percentage of Participants With Changes Between Screening and Evaluation Phase With Respect To Hb Levels	Shifts in Hb levels between Screening and Evaluation Phase were classified as follows: Category A: Participants with Hb levels in both Screening and Evaluation Phase within 10-13 g/dL; Category B: Participants who had Hb values within 10-13 g/dL during Screening but shifted outside the range during Evaluation; Category C: Participants who had Hb values outside range during Screening but shifted to stable values (at least within 10 - 13 g/dL) during Evaluation.; Category D: Participants with less than two values available during Evaluation Phase.; Participants could appear in only 1 category. Participants had to have 2 or 3 values within range (depending on the number of measurements available) to be counted.	Visits 1 to 2 (Months -2 to -1) and Visits 8 to 10 (Months 6 to 8)	No
Secondary	Percentage of Participants With Hb Fluctuations Within Evaluation Phase	Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Evaluation Phase) and was categorized as less than or equal to (=) ±1 g/dL, greater than (>) ±1.0 to ±1.5 g/dL, > ±1.5 to ±2.0 g/dL, and > ±2.0 g/dL. Percentage of participants within these deviation categories were reported for Evaluation Phase of the study.	Visits 8 to 10 (Months 6 to 8)	No
Secondary	Percentage of Participants With Hb Fluctuations Within Screening Phase	Hematology and clinical chemistry were performed partially by a central laboratory as well as by the local laboratories by means of their established methods. Normal ranges and methods as well as quality assurance certificates had to be available to the sponsor prior to the start of the study. Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Screening Phase) and was categorized as = ±1 g/dL, >±1.0 to ±1.5 g/dL, >±1.5 to ±2.0 g/dL, and >±2.0 g/dL. Percentage of participants within these deviation categories are reported for Screening Phase of the study.	Visits 1 to 2 (Months -2 to -1)	No
Secondary	Percentage of Participants Requiring Erythrocyte Transfusions		Visits 1 to 10 (Months -2 to 8)	No