A Study Comparing Subcutaneous Mircera and Darbepoetin Alfa for Maintenance Treatment of Anemia in Kidney Transplant Recipients.
Primary Purpose
Anemia
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Darbepoetin alfa
methoxy polyethylene glycol-epoetin beta [Mircera]
Sponsored by

About this trial
This is an interventional treatment trial for Anemia
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CERA Treatment Once Monthly
Darbepoetin Alfa Once Biweekly
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Percentage of Participants Maintaining Hb Concentration in 10-12 g/dL Range Throughout the Efficacy Evaluation Period (EEP)
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.
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00605345
Brief Title
A Study Comparing Subcutaneous Mircera and Darbepoetin Alfa for Maintenance Treatment of Anemia in Kidney Transplant Recipients.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CERA Treatment Once Monthly
Arm Type
Experimental
Arm Title
Darbepoetin Alfa Once Biweekly
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Darbepoetin alfa
Intervention Description
As prescribed
Intervention Type
Drug
Intervention Name(s)
methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention Description
120, 200 or 360 micrograms sc 4-weekly (starting dose)
Primary Outcome Measure Information:
Title
The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range
Description
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 Outcome Measure Information:
Title
Mean Change in Hb Concentration From Baseline to Efficacy Evaluation Period (EEP)
Description
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
Title
Percentage of Participants Maintaining Hb Concentration in 10-12 g/dL Range Throughout the Efficacy Evaluation Period (EEP)
Time Frame
Weeks 16-28
Title
Mean Time Spent in 10-12g/dL Range During the Efficacy Evaluation Period (EEP)
Description
Efficacy Evaluation Period was the 12 weeks following 16 weeks of treatment in the Dose Titration Period.
Time Frame
Weeks 16-28
Title
Percentage of Participants Needing Dose Adjustments
Description
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
Title
Incidence of RBC Transfusions
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08915
Country
Spain
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
City
Córdoba
State/Province
Cordoba
ZIP/Postal Code
14004
Country
Spain
City
La Coruna
State/Province
La Coruña
ZIP/Postal Code
15006
Country
Spain
City
Santiago de Compostela
State/Province
La Coruña
ZIP/Postal Code
15706
Country
Spain
City
Barakaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
City
Galdakao
State/Province
Vizcaya
ZIP/Postal Code
48960
Country
Spain
City
Alicante
ZIP/Postal Code
03010
Country
Spain
City
Badajoz
ZIP/Postal Code
06080
Country
Spain
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Ciudad Real
ZIP/Postal Code
13005
Country
Spain
City
Granada
ZIP/Postal Code
18014
Country
Spain
City
Madrid
ZIP/Postal Code
28007
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Madrid
ZIP/Postal Code
28222
Country
Spain
City
Valencia
ZIP/Postal Code
46017
Country
Spain
City
Valladolid
ZIP/Postal Code
47005
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
23325012
Citation
Campistol JM, Carreno A, Morales JM, Pallardo L, Franco A, Navarro D, Grinyo JM, Montenegro J, Sanchez Fructuoso AI, Romero R, Guirado L, Arias M; TIVOLI Study Group. Once-monthly pegylated epoetin Beta versus darbepoetin alfa every two weeks in renal transplant recipients: a randomized trial. Transplantation. 2013 Jan 27;95(2):e6-e10. doi: 10.1097/TP.0b013e3182782f3a. No abstract available.
Results Reference
derived
Learn more about this trial
A Study Comparing Subcutaneous Mircera and Darbepoetin Alfa for Maintenance Treatment of Anemia in Kidney Transplant Recipients.
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