Phase 4
N=87
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
Bottom Line
View on ClinicalTrials.gov: NCT01519947 ↗Enrolled (actual)
87
Serious AEs
14.0%
Results posted
Dec 2018
Primary outcome: Primary: Mean Dose Required to Achieve Target Hemoglobin of 11-12 g/dL — 150.3; 194.7; 98.7; 66.6 micrograms (mcg)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Methoxy polyethylene glycol-epoetin beta (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Dose Required to Achieve Target Hemoglobin of 11-12 g/dL |
150.3; 194.7; 98.7; 66.6 | — |
| SECONDARY Change in Hemoglobin Concentration |
1.4; 2.5; 2.0; 2.4 | — |
| SECONDARY Percentage of Participants Achieving Target Hemoglobin Concentration 11-12 g/dL After 3 and 6 Months of Treatment |
36.8; 10.0; 0.0; 28.6; 52.6; 0.0 | — |
| SECONDARY Percentage of Participants With Adverse Events |
84.2; 90.0; 66.7; 85.7 | — |
| SECONDARY Percentage of Participants Requiring Dose Adjustments |
— | — |
| SECONDARY Incidence of Red Blood Cell Transfusions |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT01519947). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.