Clinical trial NCT01519947: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia, Kidney Disease, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-01-27
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Mean Dose Required to Achieve Target Hemoglobin of 11-12 g/dL
timeFrame: Up to approximately 20 months
Secondary outcomes:
measure: Change in Hemoglobin Concentration
timeFrame: From baseline to 6 months
measure: Percentage of Participants Achieving Target Hemoglobin Concentration 11-12 g/dL After 3 and 6 Months of Treatment
timeFrame: 3 and 6 months
measure: Percentage of Participants With Adverse Events
timeFrame: Up to approximately 20 months
measure: Percentage of Participants Requiring Dose Adjustments
timeFrame: Up to approximately 20 months
measure: Incidence of Red Blood Cell Transfusions
timeFrame: Up to approximately 20 months
Other outcomes:
Locations:
city: Aguascalientes
country: Mexico
facility: Clínica San Cosme Centro Especializado en el Tratamiento de Enfermedades Renales S.C
city: Delegación Coyoacan
country: Mexico
facility: Nefros Investigación S.C.
city: Mexicali
country: Mexico
facility: Centro de hemodialisis del norte S.C.
city: Mexico City
country: Mexico
facility: Hospital Angeles Lindavista;Nefrologia
city: Morelia
country: Mexico
facility: Hospital Star Medica Morelia
city: Pureto Vallarta
country: Mexico
facility: Unidad De Dialisis La Loma S.C.
city: Veracruz
country: Mexico
facility: Hospital Regional De Alta Especialidad De Veracruz; Nephrology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: