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Completed

NCT Number: NCT00642304

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

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Twenteborg Ziekenhuis, Almelo, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methoxy polyethylene glycol-epoetin beta [C.E.R.A.]

Drug

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.

Primary outcomes

  1. 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)

    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 outcomes

  1. 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)

    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.

  2. 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)

    The EEP was defined as Week 16 to Week 24.

  3. Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP

    Time frame: EEP (Weeks 16 to 24)

    The EEP was defined as Week 16 to Week 24.

  4. Percentage of Participants With Blood Transfusion

    Time frame: Baseline up to Week 28

  5. Percentage of Participants With Dose Adjustment

    Time frame: Baseline up to Week 20

    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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 25, 2008
Registry last updated
Jun 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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