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Completed

NCT Number: NCT00660023

A Study of Intravenous Mircera in Participants With Chronic Renal Anemia Who Are on Dialysis

This single-arm study will assess the efficacy and safety of monthly administration of intravenous methoxy polyethylene glycol-epoetin beta (CERA/Mircera) for the maintenance of hemoglobin (Hb) levels in participants on dialysis with chronic renal anemia in routine clinical practice in Hungary. Participants currently receiving maintenance treatment with intravenous epoetin or darbepoetin will receive monthly injections of Mircera, with the starting dose derived from the erythropoiesis-stimulating agent (ESA) dose they had been receiving.

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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

Baja, Hungary

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults greater than or equal to (≥) 18 years of age
  • Chronic renal anemia
  • Continuous stable intravenous or subcutaneous maintenance epoetin or darbepoetin therapy during previous month
  • Regular long-term hemodialysis therapy with the same mode of dialysis for the previous 3 months

Exclusion criteria

  • Transfusion of red blood cells during previous 2 months
  • Poorly controlled hypertension
  • Significant acute or chronic bleeding

Treatment and study plan

methoxy polyethylene glycol-epoetin beta

Drug

Participants will receive intravenous CERA/Mircera every month, with starting dose based on previous ESA therapy. Treatment will continue for 52 weeks.

Other names: CERA/Mircera

Primary outcomes

  1. Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP)

    Time frame: Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24

    Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the target range of 10.0 to 12.0 g/dL and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.

Secondary outcomes

  1. Mean Change in Time-Adjusted Hb From Baseline to EEP

    Time frame: At Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24

    Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The average Hb during the EEP was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., "Baseline") Hb and the EEP average Hb was calculated and expressed in g/dL.

  2. Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP

    Time frame: Pre-dose (0 hours) during Weeks 18, 20, 22, and 24

    During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The percentage of participants who maintained each single Hb measurement in the target range of 10.0 to 12.0 g/dL was determined. The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds.

  3. Mean Time Spent in the Target Range for Hb During the EEP

    Time frame: Pre-dose (0 hours) during Weeks 18, 20, 22, and 24

    During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. Time spent in the target range of 10.0 to 12.0 g/dL was defined as time from first on-target Hb to time of last known on-target Hb, as collected during the EEP. Time spent in the target range was averaged among all participants and expressed in days.

  4. Mean Dose of Mircera/CERA During the Dose Titration Period (DTP) and EEP

    Time frame: Weeks 0, 4, 8, 12, 16, 20, and 24

    Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 18 to 24) on the basis of Hb levels or other modification criteria. The dose received at each administration visit was averaged among all participants during the DTP and EEP and expressed in mcg.

  5. Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the DTP and EEP

    Time frame: Weeks 0, 4, 8, 12, 16, 20, and 24

    Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 18 to 24) on the basis of Hb levels or other modification criteria. The percentage of participants who required a dose adjustment for any reason was calculated during the DTP and EEP.

  6. Number of Participants Receiving Blood Transfusion During the DTP and EEP

    Time frame: Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24

    The number of participants who received blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported.

  7. Number of Blood Transfusions During the DTP and EEP

    Time frame: Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24

    The number of blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Single Arm, Open Label Study to Assess the Efficacy, Safety, and Tolerability of Once-Monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 17, 2008
Registry last updated
Mar 15, 2016

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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