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

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.

Study Overview

• Status: Completed
• Conditions: Anemia, Kidney Disease, Chronic
• Intervention / Treatment: Drug: Methoxy polyethylene glycol-epoetin beta

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Phase 4

Contacts and Locations

Study Locations

• Mexico
  • Aguascalientes, Mexico, 20210
    • Clínica San Cosme Centro Especializado en el Tratamiento de Enfermedades Renales S.C
  • Delegación Coyoacan, Mexico, CP. 04700
    • Nefros Investigación S.C.
  • Mexicali, Mexico, 21100
    • Centro de hemodialisis del norte S.C.
  • Mexico City, Mexico, 07760
    • Hospital Angeles Lindavista;Nefrologia
  • Morelia, Mexico, 58070
    • Hospital Star Medica Morelia
  • Pureto Vallarta, Mexico, 48333
    • Unidad De Dialisis La Loma S.C.
  • Veracruz, Mexico, 91700
    • Hospital Regional De Alta Especialidad De Veracruz; Nephrology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: 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 Names: Mircera

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Dose Required to Achieve Target Hemoglobin of 11-12 g/dL	Up to approximately 20 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Up to approximately 20 months
Percentage of Participants Requiring Dose Adjustments	This outcome measure was not assessed.	Up to approximately 20 months
Incidence of Red Blood Cell Transfusions	This outcome measure was not assessed.	Up to approximately 20 months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2012
• Primary Completion (Actual): May 30, 2015
• Study Completion (Actual): May 30, 2015

Study Registration Dates

• First Submitted: January 18, 2012
• First Submitted That Met QC Criteria: January 24, 2012
• First Posted (Estimate): January 27, 2012

Study Record Updates

• Last Update Posted (Actual): June 19, 2019
• Last Update Submitted That Met QC Criteria: June 17, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Hematologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: ML25754

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No