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

Anemia, Kidney Disease, Chronic Clinical Trial

— ALTITUD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01519947
• Other study ID #: ML25754
• Status: Completed
• Phase: Phase 4
• Start date: May 30, 2012
• Est. completion date: May 30, 2015

Study information

• Verified date: June 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: May 30, 2015
• Est. primary completion date: May 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Kidney Disease, Chronic
• Chronic Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Methoxy polyethylene glycol-epoetin beta
Participants received 50-250 mcg SC according to local label

Locations

Country	Name	City	State
Mexico	Clínica San Cosme Centro Especializado en el Tratamiento de Enfermedades Renales S.C	Aguascalientes
Mexico	Nefros Investigación S.C.	Delegación Coyoacan
Mexico	Centro de hemodialisis del norte S.C.	Mexicali
Mexico	Hospital Angeles Lindavista;Nefrologia	Mexico City
Mexico	Hospital Star Medica Morelia	Morelia
Mexico	Unidad De Dialisis La Loma S.C.	Pureto Vallarta
Mexico	Hospital Regional De Alta Especialidad De Veracruz; Nephrology	Veracruz

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Dose Required to Achieve Target Hemoglobin of 11-12 g/dL		Up to approximately 20 months
Secondary	Change in Hemoglobin Concentration		From baseline to 6 months
Secondary	Percentage of Participants Achieving Target Hemoglobin Concentration 11-12 g/dL After 3 and 6 Months of Treatment		3 and 6 months
Secondary	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
Secondary	Percentage of Participants Requiring Dose Adjustments	This outcome measure was not assessed.	Up to approximately 20 months
Secondary	Incidence of Red Blood Cell Transfusions	This outcome measure was not assessed.	Up to approximately 20 months