Back to resultsA Study of Subcutaneous Mircera, Versus no Erythropoiesis-Stimulating Agent (ESA) Therapy, in the Treatment of Anemia in Patients With Chronic Kidney Disease After Kidney Transplant
Primary Purpose
Anemia
Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
methoxy polyethylene glycol-epoetin beta [Mircera]
Supportive treatment
Sponsored by
About this trial
This is an interventional treatment trial for Anemia
Eligibility Criteria
Inclusion Criteria:
- adult patients, >=18 years of age;
- kidney transplant >=6 months and <5 years prior to randomization;
- anemia;
- no ESA therapy during 3 months prior to randomization.
Exclusion Criteria:
- requirement for hemodialysis or peritoneal dialysis within 3 months prior to randomization;
- change in Hb concentration >=1.5g/dL during screening period;
- transfusion of red blood cells during 3 months prior to randomization;
- poorly controlled hypertension;
- significant acute or chronic bleeding within 3 months prior to randomization.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Change in Hb concentration between baseline and efficacy evaluation period (EEP).
Secondary Outcome Measures
Change in Hb concentration, percentage of patients maintaining average Hb concentration within target range, percentage of patients requiring dose adjustments, incidence of RBC transfusions.
SF36
AEs, laboratory parameters.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00576602
Brief Title
A Study of Subcutaneous Mircera, Versus no Erythropoiesis-Stimulating Agent (ESA) Therapy, in the Treatment of Anemia in Patients With Chronic Kidney Disease After Kidney Transplant
Official Title
A Randomized, Open Label Study to Evaluate the Effect of Subcutaneous Mircera, Versus no ESA Therapy, on Hemoglobin Levels in Chronic Kidney Disease Patients With Anemia After Kidney Transplant.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
poor recruitment
Study Start Date
December 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (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 2 arm study will assess the efficacy, safety and tolerability of subcutaneous Mircera, versus no ESA therapy, in chronic kidney disease patients with anemia after kidney transplant, not currently treated with ESA. Patients will be randomized to receive a)subcutaneous Mircera at a recommended starting dose of 0.6 micrograms/kg every 2 weeks, switching to monthly treatment at week 16 or b)supportive treatment (eg. iron supplementation) for management of low hemoglobin concentrations. 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 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention Description
Recommended starting dose of 0.6 micrograms/kg sc every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Supportive treatment
Intervention Description
As prescribed
Primary Outcome Measure Information:
Title
Change in Hb concentration between baseline and efficacy evaluation period (EEP).
Time Frame
Weeks 13-16
Secondary Outcome Measure Information:
Title
Change in Hb concentration, percentage of patients maintaining average Hb concentration within target range, percentage of patients requiring dose adjustments, incidence of RBC transfusions.
Time Frame
Throughout study
Title
SF36
Time Frame
Weeks 16 and 48
Title
AEs, laboratory parameters.
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients, >=18 years of age;
kidney transplant >=6 months and <5 years prior to randomization;
anemia;
no ESA therapy during 3 months prior to randomization.
Exclusion Criteria:
requirement for hemodialysis or peritoneal dialysis within 3 months prior to randomization;
change in Hb concentration >=1.5g/dL during screening period;
transfusion of red blood cells during 3 months prior to randomization;
poorly controlled hypertension;
significant acute or chronic bleeding within 3 months prior to randomization.
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
Edegem
Country
Belgium
City
Gent
Country
Belgium
City
Leuven
Country
Belgium
City
Amiens
Country
France
City
Caen
Country
France
City
Le Kremlin-Bicetre
Country
France
City
Nice
Country
France
City
Paris
Country
France
City
Toulouse
Country
France
City
Tours
Country
France
City
Berlin
Country
Germany
City
Frankfurt AM Main
Country
Germany
City
Kaiserslautern
Country
Germany
City
Kiel
Country
Germany
City
Munchen
Country
Germany
City
Bari
Country
Italy
City
Barcelona
Country
Spain
City
Santander
Country
Spain
City
Sevilla
Country
Spain
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of Subcutaneous Mircera, Versus no Erythropoiesis-Stimulating Agent (ESA) Therapy, in the Treatment of Anemia in Patients With Chronic Kidney Disease After Kidney Transplant
We'll reach out to this number within 24 hrs