A Study of Once Monthly Subcutaneous Mircera in Patients With Chronic Renal Anemia Not on Dialysis

NCT00922116 | Completed Phase 4 Results

• 1 other identifier: ML22285
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 10

Brief Summary

This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in patients with chronic renal anemia not on dialysis.Patients will receive sc Mircera at a starting dose of 100, 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of ESA previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP)

  The target hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (Stability Verification Period \[SVP\]). EEP was an 8 week period from Weeks 17 to 24. The 95 percent (%) confidence interval (CI) was estimated using Clopper-Pearson.

  EEP (Weeks 17 to 24)

Secondary Outcomes (5)

• Change in Hemoglobin Concentration Between SVP and the EEP

  SVP (Baseline), and EEP (Weeks 17 to 24)

• Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 10.0 to 12.0 g/dL Throughout the EEP

  EEP (Weeks 17 to 24)

• Percentage of Participants Who Required Dose Adjustments During Dose Titration Period (DTP) and EEP

  Weeks 1 to 24

• Time Spent in Hemoglobin Range of 10.0 to 12.0 g/dL During DTP and EEP

  Weeks 1 to 24

• Average Dose of Mircera Per Month

  Weeks 0-4, 4-8, 8-12, 12-16, 16-20, and 20-24

Study Arms (1)

1

EXPERIMENTAL

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Interventions

methoxy polyethylene glycol-epoetin beta [Mircera] DRUG

sc every month (starting dose of 100, 120, 150 or 200 micrograms based on previous ESA therapy)

1

Eligibility Criteria

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

You may qualify if:

• adult patients, \>=18 years of age;
• chronic renal anemia;
• continuous maintenance ESA therapy with the same dosing interval during the previous month, and no change in totally weekly dose.

You may not qualify if:

• transfusion of red blood cells during previous 2 months;
• poorly controlled hypertension;
• significant acute or chronic bleeding;
• active malignant disease (except non-melanoma skin cancer).

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (10)

Inje University Busan Paik Hospital; Nephrology

Busan, 633-165, South Korea

Location

Kyungpook National Uni Hospital; Internal Medicine

Daegu, 700-721, South Korea

Location

Chungnam National Uni Hospital; Nephrology

Daejeon, 301-721, South Korea

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

NHIC Ilsan Hospital

Kyonggi-do, 411-719, South Korea

Location

Seoul National Uni Hospital; Internal Medicine

Seoul, 03080, South Korea

Location

Seoul St Mary's Hospital

Seoul, 06591, South Korea

Location

Severance Hospital; Division of Nephrology

Seoul, 120-752, South Korea

Location

East-West Neo Medical Center; Division Of Nephology

Seoul, 134-837, South Korea

Location

Samsung Medical Centre; Department of Hematology & Oncology

Seoul, 135-710, South Korea

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: June 16, 2009
• First Posted: June 17, 2009
• Study Start: April 30, 2009
• Primary Completion: November 30, 2010
• Study Completion: November 30, 2010
• Last Updated: July 13, 2017
• Results First Posted: December 9, 2015

Record last verified: 2017-05

Locations

KR (10)