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Completed

NCT Number: NCT00882713

A Study of Once Monthly Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia

This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients will receive subcutaneous Mircera at a starting dose of 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of epoetin or darbepoetin alfa previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. Treatment duration is 56 weeks, and the target sample size is 200 individuals.

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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

Agadir, Morocco

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult patients >=18 years of age;
  • chronic renal anemia;
  • regular long-term hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months;
  • continuous iv maintenance epoetin alfa therapy with same dosing interval during previous 2 months.

Exclusion criteria

  • transfusion of red blood cells during previous 2 months;
  • poorly controlled hypertension;
  • significant acute or chronic bleeding;
  • active malignant disease (except non-melanoma skin cancer).

Treatment and study plan

methoxy polyethylene glycol-epoetin beta [Mircera]

Drug

Subcutaneous injection every 4 weeks (starting dose of 120, 200 or 360 micrograms, based on previous ESA therapy)

Other names: C.E.R.A.

Primary outcomes

  1. Percentage of Participants Maintaining Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period

    Time frame: EEP (Week 17 to Week 24)

    The percentage of participants who maintained their mean Hb concentration within +/- 1 g/dL of their reference Hb and between 10.5 and 12.5 g/dL during the Efficacy Evaluation Period (EEP) is reported. The EEP was from Week 17 to Week 24. The reference Hb was calculated from the mean of Hb concentrations based upon the Hb assessments at Weeks -4, -3, -2, -1, and 0.

Secondary outcomes

  1. Mean Change in Hemoglobin Concentration Between Reference (Stability Verification Period) and the Efficacy Evaluation Period

    Time frame: SVP (Weeks -3, -2, -1) and EEP (Week 17 to Week 24)

    Mean change in Hb concentration between reference SVP and the EEP is reported. The SVP was at Weeks -3, -2, -1, and EEP was from Week 17 to Week 24. Participants received epoetin alfa or beta during SVP.

  2. Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.5-12.5 g/dL Throughout the EEP

    Time frame: EEP (Week 17 to Week 24)

    Percentage of participants maintaining Hb concentration within the range of 10.5-12.5 g/dL throughout the EEP is reported. The EEP was from Week 17 to Week 24.

  3. Mean Time Spent By Participants With Hemoglobin Range of 10.5-12.5 g/dL During the EEP

    Time frame: EEP (Week 17 to Week 24)

    Mean time spent by participants in Hb range of 10.5-12.5 g/dL during the EEP is reported. The EEP was from Week 17 to Week 24.

  4. Number of Participants With Any Adverse Events or Serious Adverse Events

    Time frame: Up to Week 52

    An adverse event (AE) is untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAEs) is with any of the following outcomes: Death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, and congenital anomaly.

  5. Percentage of Participants Requiring Any Dose Adjustment During DTP and EEP

    Time frame: DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24)

    Percentage of participants requiring any dose adjustment during DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24) is reported. The dose adjustments (increase or decrease) were required: if a single Hb concentration was either > or = 13 g/dL or < or = 9 g/dL; if the difference of 2 consecutive Hb concentrations was > or =2 g/dL; if the values of scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of range of 10.5 to 11.5 g/dL, the difference between the reference value (mean of Hb concentrations based on the Hb assessments at Weeks -4, -3, -2, -1, and 0) and the most recent value was >1 g/dL; if the values of the scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of the range 10 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.

  6. Incidences of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase

    Time frame: Up to Week 52

    Red Blood Cells (RBCs) transfusions were given during the treatment period in case of medical need. Blood transfusions occurred during the DTP, EEP, and during the long term safety period (LTSP) were reported.

  7. Mean Hemoglobin Levels Over Time

    Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48

    The Hb levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.

  8. Mean Hematocrit Levels Over Time

    Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48

    The hematocrit (HCT) levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.

  9. Mean Albumin Levels Over Time

    Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48

    The albumin levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.

  10. Mean White Blood Cells and Thrombocytes Over Time

    Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48

    The white blood cells (WBCs) and thrombocyte levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.

  11. Mean Phosphate and Potassium Levels Over Time

    Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48

    The phosphate and potassium levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.

  12. Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time

    Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48

    The mean creatinine, iron, and total iron binding capacity (TIBC) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.

  13. Mean C-Reactive Protein Levels Over Time

    Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48

    The mean C-Reactive Protein (CRP) Levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.

  14. Mean Ferritin Levels Over Time

    Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48

    The mean ferritin levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.

  15. Mean Transferrin Saturation Levels Over Time

    Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48

    The mean transferrin saturation (TSAT) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.

  16. Mean Change From Baseline in Pulse Rate Over Time

    Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48

    Mean change in pulse rate was defined as the difference between mean pulse rate at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48).

  17. Mean Change From Baseline in Blood Pressure Over Time

    Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48

    Mean change in blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) before and after dialysis was defined as the difference between mean blood pressure at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48).

  18. Mean Change From Baseline in Weight Over Time

    Time frame: Week 16 and Week 48

    Mean change in weight was defined as the difference between mean weight at Baseline and following visits (Week 16 and Week 48).

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 Subcutaneous CERA for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anemia

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 16, 2009
Registry last updated
Oct 7, 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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