Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

A Study of The Effect of Altitude on Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) Dose Requirements in Patients With Chronic Renal Anemia in Pre-Dialysis or Dialysis

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: January 18, 2012
Last updated: November 1, 2016
Last verified: November 2016
This comparative, open-label, multicenter, parallel-group study will evaluate the effect of altitude on dose requirements of Mircera (methoxy polyethylene glycol-epoetin beta) to achieve a target haemoglobin concentration of 11-12 g/dL in patients with chronic renal anemia in pre-dialysis and dialysis. Four groups of patients, at sea level or an altitude above 6'000 feet and in pre-dialysis or dialysis, will receive 50-250 mcg Mircera subcutaneously according to local label. Anticipated time on study treatment is 36 weeks.

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Study to Assess the Effect of the Altitude on Dose Requirements of Methoxy Polyethylene Glycol-epoetin Beta to Correct Haemoglobin Levels in Chronic Renal Anemia in Pre-dialysis and Dialysis Patients

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Dosage required to achieve target haemoglobin concentration of 11-12 g/dL [ Time Frame: approximately 20 months ]

Secondary Outcome Measures:
  • Change in haemoglobin concentration [ Time Frame: from baseline to Month 6 ]
  • Percentage of patients achieving target haemoglobin concentration 11-12 g/dL after 3 and 6 months of treatment [ Time Frame: approximately 20 months ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 20 months ]
  • Proportion of patients requiring dose adjustments [ Time Frame: approximately 20 months ]
  • Incidence of red blood cell transfusions [ Time Frame: approximately 20 months ]

Enrollment: 86
Study Start Date: May 2012
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dialysis >6000 feet Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
50-250 mcg sc according to local label
Active Comparator: Dialysis sea level Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
50-250 mcg sc according to local label
Experimental: Pre-dialysis >6000 feet Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
50-250 mcg sc according to local label
Active Comparator: Pre-dialysis sea level Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
50-250 mcg sc according to local label


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

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Chronic kidney disease stage III-IV or V
  • Probable start of dialysis within 18 months (pre-dialysis group)
  • Hemodialysis or peritoneal dialysis in a stable regimen for at least 3 months (dialysis group)
  • Adequate iron status
  • Females of childbearing potential must agree to use two effective methods of contraception during the study and for at least 2 months following the last dose of study drug

Exclusion Criteria:

  • Failing renal allograft in place
  • Acute or chronic bleeding within 8 weeks prior to screening
  • Transfusion of red blood cells within 8 weeks prior to screening
  • Poorly controlled hypertension, defined as hypertension that needs hospitalization to obtain control
  • History of seizures, hemoglobinopathies and/or severe liver disease
  • Active malignant disease, except for non-melanoma skin cancer
  • Immunosuppressive therapy in the 12 weeks prior to screening
  • Treatment with any other investigational agent or participation in a clinical trial within 28 days prior to enrolment
  • Known hypersensitivity to Mircera (methoxy polyethylene glycol-epoetin beta) or any of its excipients
  • Pregnant or lactating women
  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 identifier: NCT01519947

Aguascalientes, Mexico, 20210
Delegación Coyoacan, Mexico, CP. 04700
Mexicali, Mexico, 21100
Mexico City, Mexico, 07760
Morelia, Mexico, 58070
Pureto Vallarta, Mexico, 48333
Veracruz, Mexico, 91700
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01519947     History of Changes
Other Study ID Numbers: ML25754
Study First Received: January 18, 2012
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Kidney Diseases
Chronic Disease
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes
Renal Insufficiency
Epoetin Alfa
Hematinics processed this record on May 23, 2017