A Study for Monthly Methoxy Polyethylene Glycol-Epoetin Beta Treatment in Patients With Chronic Renal Anaemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01066000
First received: February 9, 2010
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This open-label single-arm study will evaluate the efficacy, safety and tolerabi lity of methoxy polyethylene glycol epoetin beta on long-term maintenance of hae moglobin levels in patients with chronic renal anaemia. Patients will receive me thoxy polyethylene glycol-epoetin beta intravenously once monthly at initial dos es of either 120 micrograms or 200 micrograms or 360 micrograms in the titration phase of 16 weeks with a potential dose adjustment in the evaluation phase of 8 weeks. The anticipated time on study treatment is 24 weeks. The target sample s ize is 50-100 patients.


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 Interventional Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous Methoxy-polyethylene Glycol-epoetin Beta for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Long-term maintenance of haemoglobin levels [ Time Frame: Throughout study, weeks 1 and 2 and every 2 weeks thereafter ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and Tolerability: AEs, laboratory parameters [ Time Frame: Laboratory parameters: throughout study, weeks 1 and 2 and every 2 weeks thereafter ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: October 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
initial doses of either 120 micrograms or 200 micrograms or 360 micrograms, once monthly

  Eligibility

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

Inclusion Criteria:

  • Adults >/=18 years of age
  • Chronic renal anaemia
  • Haemoglobin concentration between 10 and 12 g/dL at screening
  • Adequate iron status
  • Continuous intravenous maintenance short-acting therapy with same dosing interval for 8 weeks prior to screening
  • Regular long-term haemodialysis therapy for at least 12 weeks prior to screening

Exclusion Criteria:

  • Change in haemoglobin concentration >/=2 g/dL during screening
  • Transfusion of red blood cells less than 8 weeks prior to screening
  • Poorly controlled hypertension
  • Relevant acute or chronic bleeding requiring treatment less than 8 weeks prior to screening
  • Active malignant disease
  • Haemolysis
  • Haemoglobinopathies
  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: NCT01066000

Locations
Indonesia
Bandung, Indonesia, 40131
Denpasar, Indonesia, 80114
Jakarta, Indonesia, 10440
Jakarta, Indonesia, 14460
Jakarta, Indonesia, 12310
Jakarta, Indonesia, 10330
Jakarta, Indonesia, 11410
Medan, Indonesia, 20119
Medan, Indonesia, 20234
Semarang, Indonesia, 50136
Surabaya, Indonesia, 60286
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: NCT01066000     History of Changes
Other Study ID Numbers: ML21736
Study First Received: February 9, 2010
Last Updated: October 6, 2014
Health Authority: Indonesia: Badan Pengawas Obat dan Makanan Republik Indonesia (BPOM RI)

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014