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A Study of Subcutaneous C.E.R.A. for the Maintenance of Hemoglobin Levels in Participants With Chronic Renal Anemia Not on Dialysis.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00642304
First received: March 19, 2008
Last updated: September 16, 2016
Last verified: September 2016
  Purpose
This single arm study will assess the efficacy and safety of subcutaneous C.E.R.A. when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of C.E.R.A., with the starting dose (120, 200 or 300 micrograms [mcg] subcutaneously [SC]) derived from the dose of darbepoetin alfa or epoetin beta they were receiving 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 Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneously C.E.R.A. for the Maintenance of Hemoglobin Levels in Patients With Chronic Renal Anemia Not on Dialysis

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants Maintaining Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP) [ Time Frame: EEP (Weeks 16 to 24) ] [ Designated as safety issue: No ]
    The reference Hb value was taken as the time adjusted average of all Hb assessments during the Stability Verification Period (SVP) (Week -4 to Week 0). EEP was from Week 16 to Week 24.


Secondary Outcome Measures:
  • Mean Change in Hb Concentration Between SVP and the EEP [ Time Frame: SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24) ] [ Designated as safety issue: No ]
    The mean change in the time-adjusted average Hb concentration between the two study periods SVP (Baseline) and EEP is presented. The SVP was defined as Week -4 to Week 0. The EEP was defined as Week 16 to Week 24.

  • Percentage of Participants Maintaining Hb Concentration Within Hb Range 10.5 to 12.5 g/dL During the EEP [ Time Frame: EEP (Weeks 16 to 24) ] [ Designated as safety issue: No ]
    The EEP was defined as Week 16 to Week 24.

  • Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP [ Time Frame: EEP (Weeks 16 to 24) ] [ Designated as safety issue: No ]
    The EEP was defined as Week 16 to Week 24.

  • Percentage of Participants With Blood Transfusion [ Time Frame: Baseline up to Week 28 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Dose Adjustment [ Time Frame: Baseline up to Week 20 ] [ Designated as safety issue: No ]
    A dose adjustment was defined as a change versus the preceding dose. It included dose increase and dose reduction from the dose given at Baseline.


Enrollment: 20
Study Start Date: July 2008
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: methoxy polyethylene glycol-epoetin beta Drug: methoxy polyethylene glycol-epoetin beta [C.E.R.A.]
Methoxy polyethylene glycol-epoetin beta is administered SC every four week up to Week 20.The starting dose is 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta participants shall be receiving in the week preceding the study start. Further dose adjustment during the study depending on the hemoglobin (Hb) values.

  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
  • Stable darbepoetin alfa or epoetin beta therapy for past 8 weeks

Exclusion Criteria:

  • Transfusion of red blood cells during previous 8 weeks
  • Poorly controlled hypertension requiring interruption of epoetin treatment in previous 6 months
  • Acute or chronic bleeding requiring therapy within previous 8 weeks
  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: NCT00642304

Locations
Netherlands
Almelo, Netherlands, 7609 PP
Amersfoort, Netherlands, 3818 ES
Amsterdam, Netherlands, 1034 CS
Delft, Netherlands, 2625 AD
Doetinchem, Netherlands, 7009 BL
Dordrecht, Netherlands, 3318 AT
Goes, Netherlands, 4462 RA
Leiden, Netherlands, 2333 ZA
Nijmegen, Netherlands, 6525 GA
Utrecht, Netherlands, 3582 KE
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00642304     History of Changes
Other Study ID Numbers: ML20937 
Study First Received: March 19, 2008
Results First Received: September 16, 2016
Last Updated: September 16, 2016
Health Authority: Netherlands:Medicines Evaluation Board

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics

ClinicalTrials.gov processed this record on December 07, 2016