A Study Comparing Subcutaneous Mircera and Darbepoetin Alfa for the Maintenance Treatment of Anemia in Kidney Transplant Recipients.

Anemia Clinical Trial

Official title:

An Open Label Randomised Controlled Study to Compare the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous Mircera Versus Darboepoetin Alfa for the Maintenance of Haemoglobin Levels in Renal Transplant Recipients With Chronic Renal Anaemia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00605345
• Other study ID #: ML21058
• Status: Completed
• Phase: Phase 3
• First received: January 18, 2008
• Last updated: May 5, 2015
• Start date: December 2007
• Est. completion date: April 2010

Study information

• Verified date: May 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: AEMPS
• Study type: Interventional

Clinical Trial Summary

This 2 arm study will compare the efficacy and safety of subcutaneous Mircera versus darbepoetin alfa for the maintenance of hemoglobin levels in kidney transplant recipients with chronic renal anemia. Patients currently receiving maintenance treatment with darbepoetin alfa will be randomized either to receive 4-weekly injections of Mircera with a starting dose (120, 200 or 360 micrograms sc) derived from the dose of darbepoetin alfa they were receiving in the 2 weeks preceding study start, or to stay on 2-weekly darbepoetin alfa therapy. 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: 71
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• kidney transplant recipients with stage 3 or stage 4 chronic kidney disease;

• functioning graft of >6 months and <10 years after kidney transplantation, with no signs of acute rejection;

• stable maintenance subcutaneous darbepoetin alfa therapy every 2 weeks.

Exclusion Criteria:

• transfusion of red blood cells during previous 2 months;

• poorly controlled hypertension;

• significant acute or chronic bleeding;

• need for dialysis therapy expected in next 6 months.

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:
• Darbepoetin alfa
As prescribed
• methoxy polyethylene glycol-epoetin beta [Mircera]
120, 200 or 360 micrograms sc 4-weekly (starting dose)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients maintaining average Hb concentration within +/- 1g/dL of reference Hb, and between 10-12g/dL during evaluation period		Week 17-24	No
Secondary	Change in Hb concentration, and percentage of patients maintaining Hb concentration in 10-12 g/dL range.		Weeks 17-24	No
Secondary	Mean time in 10-12g/dL range; percentage of patients needing dose adjustments; incidence of RBC transfusions.		Throughout study	No
Secondary	AEs, laboratory parameters.		Throughout study	No