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

• ClinicalTrials.gov Identifier: NCT00462384
• Recruitment Status: Terminated
• First Posted: April 19, 2007
• Results First Posted: April 1, 2016
• Last Update Posted: April 1, 2016
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Anemia	Drug: Methoxy Polyethylene Glycol-epoetin Beta	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 39 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: February 2008
• Actual Primary Completion Date: April 2011
• Actual Study Completion Date: April 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Mean Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP) [ Time Frame: Baseline (Week -2 to 0) and EEP (Weeks 29 to 36) ]
   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.

Secondary Outcome Measures :

1. Time to Achievement of Response [ Time Frame: Baseline to Week 40 ]
   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.
2. Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL Throughout the EEP [ Time Frame: EEP (Weeks 29 to 36) ]
   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.
3. Percentage of Participants Maintaining Average Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL During the EEP [ Time Frame: EEP (Weeks 29 to 36) ]
   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.
4. Time Spent in Hemoglobin Range of 11.0 to 13.0 g/dL During the EEP [ Time Frame: EEP (Weeks 29 to 36) ]
   EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period.

Eligibility Criteria

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

Criteria

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).

Contacts and Locations

Locations

Estonia

Tallinn, Estonia, 10617

Tallinn, Estonia, 13419

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

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

More Information

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT00462384
• Other Study ID Numbers: ML20659
• First Posted: April 19, 2007
• Results First Posted: April 1, 2016
• Last Update Posted: April 1, 2016
• Last Verified: March 2016

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Hematologic Diseases; Urologic Diseases; Renal Insufficiency; Epoetin Alfa; Hematinics