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

Hoffmann-La Roche71 enrolled

Overview

This two 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 subcutaneously) 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anemia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adult patients, \> or = 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.

Locations (21)

Unnamed facility

Alicante, Alicante, Spain

Unnamed facility

Badajoz, Badajoz, Spain

Unnamed facility

Badalona, Barcelona, Spain

Unnamed facility

Barcelona, Barcelona, Spain

Unnamed facility

Barcelona, Barcelona, Spain

Unnamed facility

Barcelona, Barcelona, Spain

Unnamed facility

L'Hospitalet de Llobregat, Barcelona, Spain

Unnamed facility

Santander, Cantabria, Spain

Unnamed facility

Ciudad Real, Ciudad Real, Spain

Unnamed facility

Córdoba, Cordoba, Spain

...and 11 more locations

Outcomes

Primary Outcomes

The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range

Key outcomes will be assessed during the first 12 weeks following the 16 weeks dose titration period, i.e. during the Efficacy Evaluation Period (EEP). Assessments performed every four weeks, beginning at week 16 up to week 28. The reference haemoglobin is defined as the mean of the two assessments recorded during the SVP (weeks -4 and -2). For the purposes of efficacy assessment the target haemoglobin concentration range will be defined as ± 1 g/dL of the reference haemoglobin concentration AND within the range 10 - 12 g/dL.

Time frame: Weeks 16-28

Secondary Outcomes

Mean Change in Hb Concentration From Baseline to Efficacy Evaluation Period (EEP)

Reference haemoglobin at baseline is defined as the mean of the two assessments recorded at weeks -4 and -2. Additional assessments were then performed every 4 weeks at week 0 through week 28. Mean change was calculated as value at 28 weeks minus baseline.

Time frame: Baseline to 28 weeks

Percentage of Participants Maintaining Hb Concentration in 10-12 g/dL Range Throughout the Efficacy Evaluation Period (EEP)

Time frame: Weeks 16-28

Mean Time Spent in 10-12g/dL Range During the Efficacy Evaluation Period (EEP)

Efficacy Evaluation Period was the 12 weeks following 16 weeks of treatment in the Dose Titration Period.

Time frame: Weeks 16-28

Percentage of Participants Needing Dose Adjustments

Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP).

Time frame: Up to 28 weeks

Incidence of RBC Transfusions

Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP).

Time frame: Up to 28 weeks