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
  Purpose
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.

Condition Intervention Phase
Anemia
Drug: Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 29
Study Start Date: June 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: C.E.R.A. 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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517881

Locations
Sweden
Danderyd, Sweden, 18288
Eksjo, Sweden, 57581
Eskilstuna, Sweden, 63188
Gaevle, Sweden, 80187
Goeteborg, Sweden, 41345
Gothenburg, Sweden, S-402 76
Huddinge, Sweden, 14186
Jonkoping, Sweden, 55185
Kristianstad, Sweden, 29185
Skellefteå, Sweden, S-931 86
Stockholm, Sweden, 17176
Umea, Sweden, 90185
Värnamo, Sweden, 33185
Västervik, Sweden, 59381
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00517881     History of Changes
Other Study ID Numbers: ML20944  2006-006523-40 
Study First Received: August 16, 2007
Results First Received: April 21, 2016
Last Updated: April 21, 2016
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics

ClinicalTrials.gov processed this record on August 23, 2016