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

NCT01342640 | Completed Phase 4 Results

• 1 other identifier: ML25300
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 5

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.

Conditions

Anemia

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

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.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (5)

Mansoura Kidney Center; Nephrology

Al Mansurah, 0, Egypt

Location

Alexandria University; Endocrinology Department

Alexandria, Egypt

Location

El Qahira Al Fatemeya Hospital

Cairo, Egypt

Location

Kasr El Ainy University Hospital; Endocrinology Department

Cairo, Egypt

Location

Nasser Institute

Cairo, Egypt

Location

MeSH Terms

Conditions

Anemia

Interventions

continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2011
• First Posted: April 27, 2011
• Study Start: July 18, 2011
• Primary Completion: November 30, 2012
• Study Completion: November 30, 2012
• Last Updated: July 12, 2017
• Results First Posted: October 26, 2015

Record last verified: 2017-06

Locations

EG (5)