A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia

Anemia Clinical Trial

Official title:

An Open-label, Multi-center Study to Document the Efficacy, Safety, and Tolerability of Long-term Administration of RO0503821 in Patients With Chronic Renal Anemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00090753
• Other study ID #: BH18387
• Status: Completed
• Phase: Phase 3
• First received: September 3, 2004
• Last updated: February 10, 2012
• Start date: October 2004
• Est. completion date: December 2009

Study information

• Verified date: February 2012
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients with renal anemia. Eligible patients were those who were receiving stable maintenance therapy with methoxy polyethylene glycol-epoetin beta or erythropoiesis stimulating agents (ESAs) in Phase II or III clinical studies. They continued to receive methoxy polyethylene glycol-epoetin beta or comparator ESAs at the same weekly dose and by the same route of administration (sc or iv) as in the qualifying studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1228
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent

• Adult patients (= 18 years old) with chronic renal anemia

• Maintenance erythropoietic therapy with methoxy polyethylene glycol-epoetin beta or a protocol-specified reference medication (epoetin alfa formulated with human albumin, epoetin beta or darbepoetin alfa) in one of the following studies: BA16528[NCT00048048], BA16285[NCT00048035], BA16286[NCT00364832], BA16736[NCT00077597], BA16738[NCT00081471], BA16739[NCT00077610], BA16740[NCT00077623], BA17283[NCT00077766] and BA17284[NCT00081484]

• Hemoglobin (Hb) concentration between 10.5 and 13.0 g/dL

• Adequate iron status defined as serum ferritin = 100 ng/mL or Transferrin Saturation (TSAT)= 20% or percentage of hypochromic red blood cells (RBCs) < 10%

Exclusion Criteria:

• Poorly controlled hypertension

• History of epileptic seizure

• Pure red cell aplasia

• Chronic congestive heart failure [New York Heart Association (NYHA) IV]

• High likelihood of early withdrawal or interruption of the study

• Active malignant disease (except non-melanoma skin cancer)

• Life expectancy less than 12 months

• Pregnancy or breast-feeding

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• Methoxy Polyethylene Glycol-Epoetin Beta
Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in 2-mL glass vials containing 1 mL solution or in single-use sterile pre-filled syringes (PFSs) containing 0.3 mL or 0.6 mL injectable solution. The injectable solution was available in vials with the following strengths: 50, 100, 200, 400, and 1000 µg/mL. The injectable solution was available in PFSs with the following strengths: 30, 40, 50, 60, 75, 100, 120, 150, 200, and 250 µg/0.3 mL; and 360 and 400 µg/0.6 mL.
• Epoetin alfa
Epoetin alfa was provided with commercial packaging in English with country-specific labels (10,000 IU, 20,000 IU).
• Epoetin beta
Epoetin beta was provided with commercial packaging in English with country-specific labels (50,000 IU, 100,000 IU).
• Darbepoetin alfa
Darbepoetin alfa was provided with commercial packaging in English with country-specific labels (vials and PFSs in various strengths).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Greece,  Hungary,  Italy,  Mexico,  Netherlands,  Norway,  Panama,  Poland,  Portugal,  Puerto Rico,  Russian Federation,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation	Blood samples were collected at each study visit, that is, every 4 weeks for the first 12 weeks, every 12 weeks until week 105 of the first study period, every 3 months thereafter, and at the end of study or the last visit if the patient discontinued the study prematurely.	Baseline to the end of the study (Up to 49 Months)	No
Secondary	Percentage of Patients Who Had at Least 1 Adverse Event	See the adverse events section of the results for more information.	From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months)	Yes