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
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
1 other identifier
interventional
87
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2012
Typical duration for phase_4
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2012
CompletedFirst Posted
Study publicly available on registry
January 27, 2012
CompletedStudy Start
First participant enrolled
May 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2015
CompletedResults Posted
Study results publicly available
December 27, 2018
CompletedJune 19, 2019
June 1, 2019
3 years
January 18, 2012
September 8, 2017
June 17, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Dose Required to Achieve Target Hemoglobin of 11-12 g/dL
Up to approximately 20 months
Secondary Outcomes (5)
Change in Hemoglobin Concentration
From baseline to 6 months
Percentage of Participants Achieving Target Hemoglobin Concentration 11-12 g/dL After 3 and 6 Months of Treatment
3 and 6 months
Percentage of Participants With Adverse Events
Up to approximately 20 months
Percentage of Participants Requiring Dose Adjustments
Up to approximately 20 months
Incidence of Red Blood Cell Transfusions
Up to approximately 20 months
Study Arms (4)
Pre-dialysis, sea level
ACTIVE COMPARATORParticipants received 50-250 mcg SC according to local label.
Dialysis, sea level
ACTIVE COMPARATORParticipants received 50-250 mcg SC according to local label.
Pre-dialysis, >1800 meters
EXPERIMENTALParticipants received 50-250 mcg SC according to local label.
Dialysis, >1800 meters
EXPERIMENTALParticipants received 50-250 mcg SC according to local label.
Interventions
Participants received 50-250 mcg SC according to local label
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Clínica San Cosme Centro Especializado en el Tratamiento de Enfermedades Renales S.C
Aguascalientes, 20210, Mexico
Nefros Investigación S.C.
Delegación Coyoacan, CP. 04700, Mexico
Centro de hemodialisis del norte S.C.
Mexicali, 21100, Mexico
Hospital Angeles Lindavista;Nefrologia
Mexico City, 07760, Mexico
Hospital Star Medica Morelia
Morelia, 58070, Mexico
Unidad De Dialisis La Loma S.C.
Pureto Vallarta, 48333, Mexico
Hospital Regional De Alta Especialidad De Veracruz; Nephrology
Veracruz, 91700, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2012
First Posted
January 27, 2012
Study Start
May 30, 2012
Primary Completion
May 30, 2015
Study Completion
May 30, 2015
Last Updated
June 19, 2019
Results First Posted
December 27, 2018
Record last verified: 2019-06