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

Phase 4

Completed

• Conditions: Anemia
• Interventions: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

• Registration Number: NCT01342640
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-20
• Study First Submitted QC: 2011-04-26
• Study First Posted: 2011-04-27
• Study Start: 2011-07-18
• Primary Completion: 2012-11-30
• Study Completion: 2012-11-30
• Results First Submitted: 2015-09-28
• Results First Submitted QC: 2015-09-28
• Results First Posted: 2015-10-26
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-15
• Last Update Posted: 2017-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	methoxy polyethylene glycol-epoetin beta [Mircera]	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Hb Concentration at Week 20	Baseline (Week 0), 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 \[Weeks 20 to 28\]).
Change From Baseline in Mean Hb Concentration at Week 24	Baseline (Week 0), 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 \[Weeks 20 to 28\]).
Change From Baseline in Mean Hb Concentration at Week 28	Baseline (Week 0), Week 28	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 \[Weeks 20 to 28\]).

Trial Locations

Locations (5)

Kasr El Ainy University Hospital; Endocrinology Department; 🇪🇬 Cairo, Egypt

Nasser Institute; 🇪🇬 Cairo, Egypt

Alexandria University; Endocrinology Department; 🇪🇬 Alexandria, Egypt

Mansoura Kidney Center; Nephrology; 🇪🇬 Mansoura, Egypt

El Qahira Al Fatemeya Hospital; 🇪🇬 Cairo, Egypt