A Study of Mircera (C.E.R.A.) in Patients With Pre-Dialysis Chronic Renal Anemia

Hoffmann-La Roche70 enrolled

Overview

This single arm, open label, multicenter study will evaluate the safety and change in hemoglobin levels of Mircera (C.E.R.A.; methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia who are not on dialysis. Patients will receive as a recommended starting dose 1.2 micrograms of Mircera subcutaneously every 4 weeks. The starting dose is dependent on the patient's weight. Dose adjustment may be required due to inadequate or excessive treatment response. The anticipated time on study treatment is 28 weeks.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anemia

Interventions

methoxy polyethylene glycol-epoetin beta [Mircera]DRUG

Recommended starting dose 1.2 micrograms/kg subcutaneously every 4 weeks (depending on patient's weight). Dose adjustment may be required in the event of inadequate or excessive treatment response.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients, age \>/=18 years * Diagnosis of chronic renal anemia * Not on dialysis * Hemoglobin concentration \<10 g/dl * No erythropoiesis stimulating agent (ESA) therapy during the 3 months before study start * Estimated glomerular filtration rate (EGFR) \<60 ml/min and \>/=20 ml/min * Adequate iron status Exclusion Criteria: * Transfusion of red blood cells during the previous 2 months * Poorly controlled hypertension * Significant acute or chronic bleeding, e.g. gastrointestinal bleeding * Active malignant disease (except non-melanoma skin cancer) * Hemolysis * Hemoglobinopathies, e.g. sickle-cell disease, thalassemia

Locations (5)

Mansoura Kidney Center; Nephrology

Al Mansurah, Egypt

Alexandria University; Endocrinology Department

Alexandria, Egypt

El Qahira Al Fatemeya Hospital

Cairo, Egypt

Kasr El Ainy University Hospital; Endocrinology Department

Cairo, Egypt

Outcomes

Primary Outcomes

Change From Baseline in Mean Hb Concentration at Week 20

Per Protocol (PP) Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin less than or equal to \[≤\] 100 nanogram per milliliter \[ng/mL\] or mean transferrin saturation \[TSAT\] ≤20% or mean hypochromic red blood cells \[RBCs\] greater than or equal to \[≥\] 10% during efficacy evaluation period \[Weeks 20 to 28\]).

Time frame: Baseline (Week 0), Week 20

Change From Baseline in Mean Hb Concentration at Week 24

PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period \[Weeks 20 to 28\]).

Time frame: Baseline (Week 0), Week 24

Change From Baseline in Mean Hb Concentration at Week 28

Time frame: Baseline (Week 0), Week 28

Data from ClinicalTrials.gov

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