A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis. - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by (Responsible Party):	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00442702

Purpose

This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Anemia	Drug: Mircera Drug: Darbepoetin alfa	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-label, Randomized, Multi-center, Parallel Group Non-inferiority Study of Subcutaneous Injections of RO0503821 Given Once Monthly vs. Darbepoetin Alfa Given According to Local Label in Patients With Chronic Kidney Disease Who Are Not on Dialysis.

Resource links provided by NLM:

MedlinePlus related topics: Anemia Dialysis Kidney Failure

Drug Information available for: Darbepoetin alfa

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period [ Time Frame: Baseline (measurements at Week -4, Week -2 and Day 1) and Evaluation Period (Months 8 and 9; measurements twice a month and at the final visit). ] [ Designated as safety issue: No ]
A time adjusted average baseline hemoglobin (Hb) concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period. The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the two month evaluation period. The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb from the evaluation period Hb. All blood samples for Hb measurements were taken prior to study drug administration.

Secondary Outcome Measures:

Change in Hemoglobin Concentration From Baseline Over Time [ Time Frame: From Baseline to 9 months; blood samples for hemoglobin measurements were taken twice a month, at each study visit. ] [ Designated as safety issue: No ]
Number of Participants With Red Blood Cell (RBC) Transfusions [ Time Frame: From randomization to Month 9 ] [ Designated as safety issue: No ]
Red blood cell (RBC) transfusions could be given during the treatment period in case of medical need, i.e., in severely anemic patients with recognized symptoms or signs of anemia (e.g., in patients with acute blood loss, with severe angina, or whose Hemoglobin decreased to critical levels). The number of participants who had at least one red blood cell transfusion during the entire study, during the Titration Period and during the Evaluation Period is presented. Participants who received more than one transfusion within a defined period are only counted once.
Participants With Adverse Events [ Time Frame: Randomization to Month 10 (final visit) ] [ Designated as safety issue: No ]
Adverse events were collected during the treatment period (from the first treatment dose) up to 30 days after last dose or at least until the date of last contact if the date of last contact occurred after the specified 30 day period.

Enrollment:	228
Study Start Date:	September 2007
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Mircera Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.	Drug: Mircera Starting dose of 120, 200 and 360 micrograms administered by subcutaneous injection once a month. Other Names: RO0503821 Methoxy polyethylene glycol-epoetin beta
Active Comparator: Darbepoetin alfa Participants continued to receive the same dose of darbepoetin alfa as before screening by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).	Drug: Darbepoetin alfa As prescribed, subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling specifications. Other Name: Aranesp®

Arms

Assigned Interventions

Experimental: Mircera

Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.

Drug: Mircera

Starting dose of 120, 200 and 360 micrograms administered by subcutaneous injection once a month.

Other Names:

RO0503821
Methoxy polyethylene glycol-epoetin beta

Active Comparator: Darbepoetin alfa

Participants continued to receive the same dose of darbepoetin alfa as before screening by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).

Drug: Darbepoetin alfa

As prescribed, subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling specifications.

Other Name: Aranesp®

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, not requiring dialysis;
receiving darbepoetin alfa maintenance therapy for >=8 weeks before screening, and during screening/baseline period.

Exclusion Criteria:

overt gastrointestinal bleeding within 8 weeks before screening, or during screening/baseline period;
transfusion of red blood cells within 8 weeks before screening, or during screening/baseline period;
active malignant disease;
previous treatment with Mircera.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442702

Show 91 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:	NCT00442702 History of Changes
Other Study ID Numbers:	BH20051
Study First Received:	March 1, 2007
Results First Received:	August 29, 2011
Last Updated:	December 13, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anemia
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases

Renal Insufficiency
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012