A Study of Two-Weekly Intravenous Mircera for the Treatment of Dialysis Patients With Chronic Renal Anemia Not Receiving ESA Therapy.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00737711
First received: August 18, 2008
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This single arm study will evaluate the hemoglobin (Hb) increasing effect, safet y and tolerability of two-weekly intravenous administration of Mircera in dialys is patients with chronic renal anemia not currently treated with ESAs. Patients will receive intravenous Mircera 0.6 micrograms/kg every 2 weeks for 16 weeks wi th follow up 2 weeks after the last treatment visit. The anticipated time on stu dy treatment is 3-12 months, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Anemia
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Two Weekly Administration of Intravenous MIRCERA for the Treatment of Chronic Renal Anaemia in Dialysis Patients Not Currently Treated With ESA.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Mean change in Hb concentration from baseline to last visit [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to achievement of response (Hb target range 10.0g/dL - 12g/dL); percentage of patients with average Hb concentration between 10.0g/dL and 12.0g/dL during that last 4 weeks of treatment. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Mean time spent in the Hb range 10.0g/dL - 12.0g/dL during the last 4 weeks of treatment. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Incidence of AEs, SAEs and deaths; vital signs, laboratory parameters, ECG. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 189
Study Start Date: July 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
iv 0.6 micrograms/kg every 2 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female patients, >=18 years of age;
  • chronic renal anemia (Hb concentration 8.0g/dL - 10.0g/dL);
  • no prior erythropoietin stimulating agent (ESA) therapy.

Exclusion Criteria:

  • blood transfusion within the previous 4 weeks;
  • poorly controlled hypertension;
  • significant acute or chronic bleeding;
  • active malignant disease;
  • congestive heart failure (NYHA Class IV).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737711

Locations
India
Ahmedabad, India, 380007
Bangalore, India, 560034
Chennai, India, 603103
Coimbatore, India, 641004
Gujarat, India, 387 001
Hyderabad, India, 500001
Kerala, India, 682017
Kolkata, India, 700099
Ludhiana, India
Mumbai, India, 400026
Mumbai, India
New Delhi, India, 110017
New Delhi, India, 110026
New Delhi, India, 110 060
Vellore, India, 632 004
Vishakpatnam, India, 530002
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00737711     History of Changes
Other Study ID Numbers: ML21822
Study First Received: August 18, 2008
Last Updated: October 6, 2014
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on October 20, 2014