Efficacy, Safety and Tolerability Study of Subcutaneous C.E.R.A. in Pre-Dialysis Participants With Chronic Renal Anemia

This study has been terminated.
(The study was terminated due to the slow recruitment rate.)
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00517881
First received: August 16, 2007
Last updated: April 21, 2016
Last verified: April 2016

August 16, 2007
April 21, 2016
June 2007
November 2009   (final data collection date for primary outcome measure)
Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Their Reference Hemoglobin and Within the Target Range [ Time Frame: Week 17 up to Week 24 ] [ Designated as safety issue: No ]
Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.5 to 12.5 g/dL during the efficacy evaluation period (EEP) was reported. The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the stability verification period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 to Week 24) was estimated as a time adjusted average.
Proportion of patients maintaining average Hb concentration within target range of 10.5-12.5g/dL during evaluation period.
Complete list of historical versions of study NCT00517881 on ClinicalTrials.gov Archive Site
  • Change in Hemoglobin Concentration Between Reference (SVP) and EEP [ Time Frame: Week 17 up to Week 24 ] [ Designated as safety issue: No ]
    The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the SVP at Weeks -4, -3, -2, -1 and 0. The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week 0) and the value during EEP (Week 17 up to Week 24) was assessed.
  • Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP [ Time Frame: Week 17 up to Week 24 ] [ Designated as safety issue: No ]
    Percentage of participants maintaining hemoglobin concentration within the target range of 10.5 to 12.5 g/dL during EEP (Week 17 to Week 24) was reported.
  • Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP [ Time Frame: Week 17 up to Week 24 ] [ Designated as safety issue: No ]
    Mean time spent by participants with hemoglobin concentration within the target range of 10.5 to 12.5 g/dL during the EEP (Week 17 to Week 24) was reported.
  • Percentage of Participants Requiring Any Dose Adjustment [ Time Frame: Week 1 up to Week 16 and Week 17 up to Week 24 ] [ Designated as safety issue: No ]
    Percentage of participants requiring any adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.
  • Percentage of Participants With Red Blood Cell Transfusion During the Study [ Time Frame: Week 0 up to Week 24 ] [ Designated as safety issue: No ]
    Percentage of participant who required red blood cell transfusion during the study was reported.
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Week 0 up to Week 24 ] [ Designated as safety issue: No ]
    An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious as well as non-serious AEs.
Efficacy:Change in Hb conc. over evaluation period; % of pts. maintaining Hb conc in target range ; mean time spent in Hb target range; % of pts needing dose adjustments; incidence of RBC transfusions. safety: AEs, lab parameters
Not Provided
Not Provided
 
Efficacy, Safety and Tolerability Study of Subcutaneous C.E.R.A. in Pre-Dialysis Participants With Chronic Renal Anemia
A Single Arm Open Label Study to Assess the Efficacy, Safety and Tolerability of Once Monthly Administration of Subcutaneous C.E.R.A. for the Maintenance of Haemoglobin Levels in Pre-dialysis Patients With Chronic Renal Anaemia
This single arm study will assess the efficacy, safety and tolerability of subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) for maintenance of hemoglobin levels in pre-dialysis participants with chronic renal anemia. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa will receive monthly subcutaneous injections of C.E.R.A. with the starting dose of 120, 200 or 360 micrograms (mcg) derived from the dose of darbepoetin alfa or epoetin alfa in the week preceding study start.
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Anemia
Drug: Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)
Subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments will be performed during the study depending on the participant's blood hemoglobin levels.
Other Name: Mircera
Experimental: C.E.R.A.
Intervention: Drug: Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
29
November 2009
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Chronic renal anemia
  • Hemoglobin concentration between 10.5 gram per deciliter (g/dL) and 12.5 g/dL
  • Adequate iron status (serum ferritin greater than [>] 100 nanogram per milliliter and Transferrin Saturation >20 percent [%] or hypochromic red cells less than [<] 10%)
  • Continuous subcutaneous maintenance darbepoetin alfa therapy with same dosing interval during previous 2 months

Exclusion Criteria:

  • Transfusion of red blood cells during previous 2 months
  • Poorly controlled hypertension requiring hospitalization or interruption of darbepoetin alfa treatment in previous 6 months
  • Acute or chronic bleeding
  • Active malignant disease (except non-melanoma skin cancer)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00517881
ML20944, 2006-006523-40
No
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP