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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01519947
First received: January 18, 2012
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

This comparative, open-label, multicenter, parallel-group study will evaluate th e effect of altitude on dose requirements of Mircera (methoxy polyethylene glyco l-epoetin beta) to achieve a target haemoglobin concentration of 11-12 g/dL in p atients with chronic renal anemia in pre-dialysis and dialysis. Four groups of p atients, at sea level or an altitude above 6'000 feet and in pre-dialysis or dia lysis, 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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in haemoglobin concentration [ Time Frame: from baseline to Month 6 ] [ Designated as safety issue: No ]
  • Percentage of patients achieving target haemoglobin concentration 11-12 g/dL after 3 and 6 months of treatment [ Time Frame: approximately 20 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 20 months ] [ Designated as safety issue: No ]
  • Proportion of patients requiring dose adjustments [ Time Frame: approximately 20 months ] [ Designated as safety issue: No ]
  • Incidence of red blood cell transfusions [ Time Frame: approximately 20 months ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pre-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: Dialysis sea level Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
50-250 mcg sc according to local label
Experimental: Dialysis >6000 feet Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
50-250 mcg sc according to local label

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01519947

Locations
Mexico
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
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01519947     History of Changes
Other Study ID Numbers: ML25754
Study First Received: January 18, 2012
Last Updated: July 21, 2014
Health Authority: Mexico: Ministry of Health

Additional relevant MeSH terms:
Anemia
Chronic Disease
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hematologic Diseases
Disease Attributes
Pathologic Processes
Urologic Diseases
Renal Insufficiency
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014