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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01519947
Recruitment Status : Completed
First Posted : January 27, 2012
Results First Posted : December 27, 2018
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
This comparative, open-label, multicenter, parallel-group study evaluated the effect of altitude on the dose requirements of Mircera (methoxy polyethylene glycol-epoetin beta) to achieve a target hemoglobin concentration of 11-12 grams per deciliter (g/dL) in participants with chronic renal anemia in pre-dialysis and dialysis. Four groups of participants, at sea level (below 50 meters) or an altitude above 1800 meters, and pre-dialysis or dialysis, received 50-250 micrograms (mcg) Mircera subcutaneously (SC), according to the local prescribing label.

Condition or disease Intervention/treatment Phase
Anemia, Kidney Disease, Chronic Drug: Methoxy polyethylene glycol-epoetin beta Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study to Evaluate the Effect of the Altitude on Dosage Requirements of Methoxy Polyethylene Glycol-Epoetin Beta to Correct Hemoglobin Levels in Chronic Renal Anemia in Pre-Dialysis and Dialysis Patients
Actual Study Start Date : May 30, 2012
Actual Primary Completion Date : May 30, 2015
Actual Study Completion Date : May 30, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Dialysis

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Pre-dialysis, sea level
Participants received 50-250 mcg SC according to local label.
 Drug: Methoxy polyethylene glycol-epoetin beta
Participants received 50-250 mcg SC according to local label
Other Name: Mircera
Active Comparator: Dialysis, sea level
Participants received 50-250 mcg SC according to local label.
 Drug: Methoxy polyethylene glycol-epoetin beta
Participants received 50-250 mcg SC according to local label
Other Name: Mircera
Experimental: Pre-dialysis, >1800 meters
Participants received 50-250 mcg SC according to local label.
 Drug: Methoxy polyethylene glycol-epoetin beta
Participants received 50-250 mcg SC according to local label
Other Name: Mircera
Experimental: Dialysis, >1800 meters
Participants received 50-250 mcg SC according to local label.
 Drug: Methoxy polyethylene glycol-epoetin beta
Participants received 50-250 mcg SC according to local label
Other Name: Mircera


Outcome Measures
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Primary Outcome Measures :
  1. Mean Dose Required to Achieve Target Hemoglobin of 11-12 g/dL [ Time Frame: Up to approximately 20 months ]

Secondary Outcome Measures :
  1. Change in Hemoglobin Concentration [ Time Frame: From baseline to 6 months ]
  2. Percentage of Participants Achieving Target Hemoglobin Concentration 11-12 g/dL After 3 and 6 Months of Treatment [ Time Frame: 3 and 6 months ]
  3. Percentage of Participants With Adverse Events [ Time Frame: Up to approximately 20 months ]
    An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.

  4. Percentage of Participants Requiring Dose Adjustments [ Time Frame: Up to approximately 20 months ]
    This outcome measure was not assessed.

  5. Incidence of Red Blood Cell Transfusions [ Time Frame: Up to approximately 20 months ]
    This outcome measure was not assessed.


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

Inclusion Criteria:

  • Adult participants, >/= 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01519947


Locations
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Mexico
Clínica San Cosme Centro Especializado en el Tratamiento de Enfermedades Renales S.C
Aguascalientes, Mexico, 20210
Nefros Investigación S.C.
Delegación Coyoacan, Mexico, CP. 04700
Centro de hemodialisis del norte S.C.
Mexicali, Mexico, 21100
Hospital Angeles Lindavista;Nefrologia
Mexico City, Mexico, 07760
Hospital Star Medica Morelia
Morelia, Mexico, 58070
Unidad De Dialisis La Loma S.C.
Pureto Vallarta, Mexico, 48333
Hospital Regional De Alta Especialidad De Veracruz; Nephrology
Veracruz, Mexico, 91700
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01519947    
Other Study ID Numbers: ML25754
First Posted: January 27, 2012    Key Record Dates
Results First Posted: December 27, 2018
Last Update Posted: June 19, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Anemia
Hematologic Diseases
 Urologic Diseases
Renal Insufficiency
Epoetin Alfa
Hematinics