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

Anemia Clinical Trial

Official title:

A Single Arm, Open Label, Multicenter Phase IIIb/IV Clinical Trial to Assess the Efficacy, Safety and Tolerability of Monthly Administration of C.E.R.A. for the Treatment of Not on Dialysis Chronic Renal Anemia Not Currently Treated With ESA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01342640
• Other study ID #: ML25300
• Status: Completed
• Phase: Phase 4
• First received: April 20, 2011
• Last updated: September 28, 2015
• Start date: July 2011
• Est. completion date: November 2012

Study information

• Verified date: September 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health, Drug Policy and Planning Center
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, 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]
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]).	Baseline (Week 0), Week 20	No
Primary	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]).	Baseline (Week 0), Week 24	No
Primary	Change From Baseline in Mean Hb Concentration at 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]).	Baseline (Week 0), Week 28	No