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Completed

NCT Number: NCT00576628

A Study of Subcutaneous C.E.R.A. for the Treatment of Anemia in Pre-Dialysis Patients.

This single arm study will assess the efficacy, safety and tolerability of subcutaneous C.E.R.A. for correction of anemia and maintenance of hemoglobin levels in patients with chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible patients will receive C.E.R.A. by monthly subcutaneous injections, dependent on body weight (with a recommended starting dose of 1.2 micrograms/kg). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 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

Irkutsk, Russia

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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, with no need for dialysis expected in next 3 months;
  • adequate iron status.

Exclusion criteria

  • previous epoetin therapy within 12 weeks prior to treatment;
  • transfusion of red blood cells during 2 months prior to screening;
  • significant acute or chronic bleeding such as overt gastrointestinal bleeding;
  • hemolysis;
  • folic acid and vitamin B 12 deficiency.

Treatment and study plan

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

Drug

Recommended starting dose 1.2 micrograms/kg sc monthly

Primary outcomes

  1. Mean Change in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period

    Time frame: Baseline (Week 0) and from Week 29 to Week 36

    The mean change in Hb concentration between Baseline and Efficacy Evaluation Period (EEP) was calculated by subtracting the baseline Hb concentration from the EEP Hb concentration. Each participant included in this analysis had at least 3 recorded Hb values during EEP, and these Hb values were combined using a time-adjusted average. The EEP was from Week 29 to Week 36.

Secondary outcomes

  1. Percentage of Participants Maintaining Average Hb Concentration Within the Target Range of 11.0-13.0 g/dL Throughout the EEP

    Time frame: From Week 29 to Week 36

    Percentage of participants maintaining individual Hb concentration within the range of 11.0-13.0 g/dL was reported during EEP. The EEP was from Week 29 to Week 36.

  2. Mean Time Spent in Target Hb Range of 11.0 -13.0 g/dL During the Efficacy Evaluation Period

    Time frame: From Week 29 to Week 36

    The number of days spent by participants with Hb in range of 11.30 -13.0 g/dL was calculated during the EEP and presented. The EEP comprised was from Week 29 to Week 36.

  3. The Number of Participants Who Required Dose Adjustments During the Dose Titration Period

    Time frame: From Week 0 to Week 28 (DTP)

    The number of participants who required dose adjustments of C.E.R.A was reported during the Dose Titration Period (DTP). The DTP was from Week 0 to Week 28.

  4. Time to Achievement of Response During the Efficacy Evaluation Period

    Time frame: From Week 29 to Week 36

    The time to achievement of response was defined as the time when the participants achieved Hb concentration within the target range of 11.0 to 13.0 g/dL during the EEP. The EEP was from Week 29 to Week 36.

  5. Number of Participants With Red Blood Cells Transfusions.

    Time frame: Up to Week 52

    The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study was reported.

  6. Mean Values of Laboratory Parameter : Hb Concentration

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

    The mean Hb concentration for each individual participant throughout the study was estimated. Summary data of mean values of Hb concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.

  7. Mean Values of Laboratory Parameter : Hematocrit

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

    Hematocrit is a blood test that measures the percentage of the volume of whole blood that is made up of red blood cells (RBC). This measurement depends on the number of red blood cells and the size of red blood cells. The mean values of hematocrit for each individual participant were estimated throughout the study. Summary data of mean values of hematocrit at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.

  8. Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration

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

    The mean values of potassium and phosphate levels in serum for each individual participant were estimated throughout the study. Summary data of mean values of potassium and phosphate level in serum at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.

  9. Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity

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

    The mean values of iron and total iron binding capacity (TIBC) for each individual participant were estimated throughout the study. Summary data of mean values of iron and TIBC at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.

  10. Mean Values of Laboratory Parameter : Serum Creatinine

    Time frame: Baseline (Week 0), and Week 32

    The mean values of serum creatinine for each individual participant throughout the study were estimated. Summary data of mean values of serum creatinine at Week 0 (Baseline) and Week 32 are presented.

  11. Mean Values of Laboratory Parameter: C Reactive Protein

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

    The mean values of C reactive protein (CRP) for each individual participant throughout the study were estimated. Summary data of mean values of CRP at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.

  12. Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration

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

    The mean values of albumin and transferrin concentration for each individual participant throughout the study were estimated. Summary data of mean values of albumin and transferrin concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.

  13. Mean Values of Laboratory Parameter: Ferritin Concentration

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

    The mean values of ferritin concentration for each individual participant throughout the study were estimated. Summary data of mean values of ferritin concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.

  14. Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count

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

    The mean values of white blood cell (WBC) and thrombocyte count for each individual participant were estimated throughout the study. Summary data of mean values of WBC and thrombocyte count at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.

  15. Mean Values of Laboratory Parameters: Transferrin Saturation

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

    The mean values for transferrin saturation (TSAT) for each individual participant were estimated throughout the study. Summary data of mean values of TSAT at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.

  16. The Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period

    Time frame: From Week 29 to Week 36 (EEP)

    The number of participants who required dose adjustments of C.E.R.A was reported during the EEP. EEP was from Week 29 to Week 36.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Single Arm Open Label Multicentre Study to Assess the Efficacy, Safety and Tolerability of Monthly Administration of Subcutaneous C.E.R.A. for the Treatment of Chronic Renal Anaemia in Pre-dialysis Patients, Not Currently Treated With ESA

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 19, 2007
Registry last updated
Nov 30, 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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