A Study of Subcutaneous (sc) Mircera in Dialysis Patients With Chronic Renal Anemia.

Anemia Clinical Trial

Official title:

A Randomized, Open-label Study of Dose Conversion Factors for Maintenance Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00364832
• Other study ID #: BA16286
• Status: Completed
• Phase: Phase 2
• First received: August 15, 2006
• Last updated: January 12, 2015
• Start date: October 2001
• Est. completion date: April 2006

Study information

• Verified date: January 2015
• 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 will determine the appropriate dose and frequency of administration of sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients >=18 years of age;

• chronic renal anemia;

• on dialysis (hemodialysis or peritoneal dialysis) therapy for at least 3 months;

• receiving sc epoetin alfa or beta for at least 3 months prior to the run-in period.

Exclusion Criteria:

• women who are pregnant, breastfeeding or using unreliable birth control methods;

• use of any investigational drug within 30 days preceding the run-in phase, or during the run-in or study treatment period.

Study Design

Allocation: 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 [Mircera]
Differing doses and frequencies of sc administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Germany,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hemoglobin from baseline over time under constant dosing regimen\n		Throughout study	No
Secondary	Change in hematocrit from baseline over time under constant dosing regimen.\nVital signs, adverse events, laboratory values\n		Throughout study	No