Roche trials database

Trial information

A Study of The Effect of Altitude on Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) Dose Requirements in Patients With Chronic Renal Anemia in Pre-Dialysis or Dialysis

Status:

Recruiting

Protocol number:

ML25754

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Official Scientific Title:

Comparative study to assess the effect of the altitude on dose requirements of methoxy polyethylene glycol-epoetin beta to correct haemoglobin levels in chronic renal anemia in pre-dialysis and dialysis patients

Brief summary:

This comparative, open-label, multicenter, parallel-group study will evaluate the effect of altitude on dose requirements of Mircera (methoxy polyethylene glycol-epoetin beta) to achieve a target haemoglobin concentration of 11-12 g/dL in patients with chronic renal anemia in pre-dialysis and dialysis. Four groups of patients, at sea level or an altitude above 6'000 feet and in pre-dialysis or dialysis, will receive 50-250 mcg Mircera subcutaneously according to local label. Anticipated time on study treatment is 36 weeks. Target sample size is 140.

Study phase:

IV

Study type:

Interventional; Treatment; Non-randomized; Parallel; Safety/efficacy study

Conditions:

• Anemia
• Kidney Disease, Chronic

Intervention type:

Drug

Intervention name:

methoxy polyethylene glycol-epoetin beta [Mircera]

Primary outcome:

1. Dosage required to achieve target haemoglobin concentration of 11-12 g/dL Time frame: approximately 20 months

Key secondary outcomes:

1. Change in haemoglobin concentration Time frame: from baseline to Month 6
2. Percentage of patients achieving target haemoglobin concentration 11-12 g/dL after 3 and 6 months of treatment Time frame: approximately 20 months
3. Safety: Incidence of adverse events Time frame: approximately 20 months
4. Proportion of patients requiring dose adjustments Time frame: approximately 20 months
5. Incidence of red blood cell transfusions Time frame: approximately 20 months

Inclusion criteria:

• Adult patients, >/= 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

Gender:

Males or Females

Age limits:

Min: 18 years Max: N/A (No limit)

Accepts healthy volunteers:

No

Anticipated start date:

May, 2012

Trial registration date:

27.12.2011

Date last updated:

06.05.2013

This trial is being conducted at the following locations:

Mexico

• AGUASCALIENTES
• DISTRITO FEDERAL
• MEXICALI
• MEXICO CITY
• MORELIA
• PURETO VALLARTA
• VERACRUZ

Link to trial result