A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Participants With Chronic Kidney Disease.

An Open-label, Multi-center Study to Demonstrate Correction of Anemia and to Assess the Maintenance of Hemoglobin Levels Using Subcutaneous Once Monthly Injections of Mircera in Pre-dialysis Patients With Chronic Kidney Disease

This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in participants with chronic kidney disease who are not on dialysis and are not treated with erythropoiesis-stimulating agents (ESA). Eligible participants will receive Mircera by monthly subcutaneous injections, dependent on body weight (with a starting dose of 1.2 micrograms/kilogram [mcg/kg]). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Study Overview

• Status: Terminated
• Conditions: Anemia
• Intervention / Treatment: Drug: Methoxy Polyethylene Glycol-epoetin Beta

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 3

Contacts and Locations

Study Locations

• Estonia
  • Tallinn, Estonia, 13419
  • Tallinn, Estonia, 10617
  • Tartu, Estonia, 51014
• Finland
  • HUS, Finland, 00029
  • Joensuu, Finland, 80210
  • Jyväskylä, Finland, 40620
  • Kajaani, Finland, 87140
  • Kotka, Finland, 48210
  • Porvoo, Finland, 06151
  • Tampere, Finland, 33521
  • Turku, Finland, 20521
• Latvia
  • Jurmala, Latvia, LV2015
  • Liepaja, Latvia, 3402
  • Riga, Latvia, 1002
  • Riga, Latvia, LV1038
  • Valmiera, Latvia, 4201
  • Ventspils, Latvia, LV 3601
• Norway
  • Honefoss, Norway, 3504
  • Lillehammer, Norway, 2629
  • Oslo, Norway, 0407
  • Stavanger, Norway, 4011
  • Trondheim, Norway, 7006

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• chronic kidney disease, stage 3 or 4;
• anemia (baseline hemoglobin between 9 and 11 grams per deciliter [g/dL]).

Exclusion Criteria:

• previous therapy with ESA within 12 weeks prior to screening;
• significant acute or chronic bleeding such as overt gastrointestinal bleeding;
• red blood cell transfusions within 8 weeks before screening;
• active malignant disease (except non-melanoma skin cancer).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Methoxy Polyethylene Glycol-epoetin Beta; Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose will be 1.2 micrograms per kilogram (mcg/kg) body weight. Thereafter, throughout the duration of study the dose adjustments will be performed depending on the hemoglobin value.	Drug: Methoxy Polyethylene Glycol-epoetin Beta; Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose will be 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments will be performed depending on the hemoglobin value.; Other Names: Mircera; RO0503821

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP)	The baseline hemoglobin was defined as the mean of the assessments recorded during the screening period (Weeks -2 and 0). EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. EEP hemoglobin was defined as the mean of the assessments recorded during the EEP.	Baseline (Week -2 to 0) and EEP (Weeks 29 to 36)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Achievement of Response	Time to achievement of response was the time (number of days) required to achieve hemoglobin levels within the range of 11.0 to 13.0 g/dL.	Baseline to Week 40
Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL Throughout the EEP	EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose hemoglobin concentrations remained within the range of 11.0-13.0 g/dL at all assessments throughout the EEP is presented.	EEP (Weeks 29 to 36)
Percentage of Participants Maintaining Average Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL During the EEP	EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose average hemoglobin concentration was within the range of 11.0-13.0 g/dL during the EEP is presented.	EEP (Weeks 29 to 36)
Time Spent in Hemoglobin Range of 11.0 to 13.0 g/dL During the EEP	EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period.	EEP (Weeks 29 to 36)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: April 18, 2007
• First Submitted That Met QC Criteria: April 18, 2007
• First Posted (Estimate): April 19, 2007

Study Record Updates

• Last Update Posted (Estimate): April 1, 2016
• Last Update Submitted That Met QC Criteria: March 2, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Hematologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: ML20659