Phase 3 N=194 Treatment

A Study of Once Monthly Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia

Anemia

Bottom Line

View on ClinicalTrials.gov: NCT00882713 ↗

Enrolled (actual)

194

Serious AEs

9.8%

Results posted

Oct 2016

Primary outcome: Primary: Percentage of Participants Maintaining Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period — 52.0 Percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: Oct 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Maintaining Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period	52.0	—
SECONDARY Mean Change in Hemoglobin Concentration Between Reference (Stability Verification Period) and the Efficacy Evaluation Period	0.48	—
SECONDARY Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.5-12.5 g/dL Throughout the EEP	60.6	—
SECONDARY Mean Time Spent By Participants With Hemoglobin Range of 10.5-12.5 g/dL During the EEP	35.1	—
SECONDARY Number of Participants With Any Adverse Events or Serious Adverse Events	39; 19	—
SECONDARY Percentage of Participants Requiring Any Dose Adjustment During DTP and EEP	56; 34.6	—
SECONDARY Incidences of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase	3; 1; 2	—
SECONDARY Mean Hemoglobin Levels Over Time	11.2; 11.7; 11.8; 11.8; 11.8; 11.8	—
SECONDARY Mean Hematocrit Levels Over Time	0.34; 0.36; 0.36; 0.36; 0.36; 0.36	—
SECONDARY Mean Albumin Levels Over Time	43.1; 41.0; 41.3; 40.2; 39.9; 40.4	—
SECONDARY Mean White Blood Cells and Thrombocytes Over Time	6.5; 6.5; 6.3; 6.4; 6.3; 6.3	—
SECONDARY Mean Phosphate and Potassium Levels Over Time	1.7; 1.7; 1.7; 1.7; 1.6; 1.4	—
SECONDARY Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time	775.7; 692.5; 676.1; 683.7; 670.2; 674.8	—
SECONDARY Mean C-Reactive Protein Levels Over Time	6.9; 7.9; 8.6; 9.3; 7.1; 7.2	—
SECONDARY Mean Ferritin Levels Over Time	547.6; 522.2; 517.6; 508.6; 522.6; 562.8	—
SECONDARY Mean Transferrin Saturation Levels Over Time	37.3; 35.0; 36.0; 34.9; 35.4; 38.0	—
SECONDARY Mean Change From Baseline in Pulse Rate Over Time	0.37; 0.02; 0.30; 0.40; 0.52; 0.76	—
SECONDARY Mean Change From Baseline in Blood Pressure Over Time	1.15; -0.78; -0.58; -1.28; 0.27; -0.52	—
SECONDARY Mean Change From Baseline in Weight Over Time	-0.20; 0.06	—

Summary

This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients will receive subcutaneous Mircera at a starting dose of 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of epoetin or darbepoetin alfa previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. Treatment duration is 56 weeks, and the target sample size is 200 individuals.

Eligibility Criteria

Inclusion Criteria

adult patients >=18 years of age;
chronic renal anemia;
regular long-term hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months;
continuous iv maintenance epoetin alfa therapy with same dosing interval during previous 2 months.

Exclusion Criteria

transfusion of red blood cells during previous 2 months;
poorly controlled hypertension;
significant acute or chronic bleeding;
active malignant disease (except non-melanoma skin cancer).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00882713). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.