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Completed

NCT Number: NCT00737711

A Study of Two-Weekly Intravenous Mircera for the Treatment of Dialysis Patients With Chronic Renal Anemia Not Receiving ESA Therapy.

This single arm study will evaluate the hemoglobin (Hb) increasing effect, safety and tolerability of two-weekly intravenous administration of Mircera in dialysis patients with chronic renal anemia not currently treated with ESAs. Patients will receive intravenous Mircera 0.6 micrograms/kg every 2 weeks for 16 weeks with follow up 2 weeks after the last treatment visit. 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 4

Primary location

Ahmedabad, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • male or female patients, >=18 years of age;
  • chronic renal anemia (Hb concentration 8.0g/dL - 10.0g/dL);
  • no prior erythropoietin stimulating agent (ESA) therapy.

Exclusion criteria

  • blood transfusion within the previous 4 weeks;
  • poorly controlled hypertension;
  • significant acute or chronic bleeding;
  • active malignant disease;
  • congestive heart failure (NYHA Class IV).

Treatment and study plan

methoxy polyethylene glycol-epoetin beta [Mircera]

Drug

iv 0.6 micrograms/kg every 2 weeks

Primary outcomes

  1. Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period

    Time frame: Baseline (Week 0) and Week 16

    The difference between the mean Hemoglobin (Hb) value at the last visit (Week 16) of the treatment period (TP) and at Baseline (Week 0) is presented. TP was from Baseline to Week 16.

Secondary outcomes

  1. Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter

    Time frame: Up to Week 16

    Achievement of blood Hb levels within target range of 10.0-12.0 g/dL was considered as achievement of response. The mean time required to achieve the Hb target range is presented in weeks.

  2. Mean Time Spent in the Hemoglobin Range of 10.0-12.0 Gram/Deciliter From Week 12 to Week 16

    Time frame: Week 12 to Week 16

    The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The mean time spent (in weeks) by the participants in the target range (10-12 g/dL) during the last 4 weeks of the TP is presented.

  3. Percentage of Participants With Average Hemoglobin Concentration Between 10.0-12.0 Gram/Deciliter From Week 12 to Week 16

    Time frame: Week 12 to Week 16

    The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The percentage of participants achieving Hb levels within target range of 10.0-12.0 g/dL during the last 4 weeks of the TP is presented.

  4. Number of Participants With Adverse Events, Serious Adverse Events and Deaths

    Time frame: Up to Week 18

    An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. An SAE is any AE that can result in death or is life-threatening or required participant hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above

  5. Number of Participants With Abnormal Electrocardiogram

    Time frame: Up to Week 16

    Twelve-lead electrocardiogram (ECG) was recorded for the participants. The number of participants with abnormal ECG is presented.

  6. Number of Participants With Reports of Blood Transfusions

    Time frame: Up to Week 16

    Indications for blood transfusions were acute blood loss (bleeding), lack of treatment response or treatment failure, or other reasons.

  7. Number of Participants With Reports of Anti-Epoetin Antibodies

    Time frame: Up to Week 16

    Participants were assessed for the presence of Anti-Epoetin antibodies for MIRCERA.

  8. Mean White Blood Cell Count Over Time

    Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16

    The mean values of white blood cells are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  9. Mean Value of Mean Corpuscular Volume Over Time

    Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16

    Mean corpuscular volume (MCV) is a measure of the average volume of red blood corpuscles (RBCs) and is calculated by dividing hematocrit value by the concentration of RBCs. Mean values of MCV are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. Reference range of mean corpuscular volume is 80-96 femtoliter (fL) per red blood cell.

  10. Mean Hypochromic Red Blood Cells Over Time

    Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16

    Mean values of hypochromic RBCs are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  11. Mean Platelet Count Over Time

    Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16

    Mean values of platelet count are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  12. Mean Serum Iron Over Time

    Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16

    Mean values of serum iron are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  13. Mean Serum Ferritin Over Time

    Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16

    Mean values of serum ferritin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  14. Mean Transferrin Over Time

    Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16

    Mean values of serum transferrin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  15. Mean Total Iron-binding Capacity Over Time

    Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16

    Mean values of total iron-binding capacity are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  16. Mean Transferrin Saturation Over Time

    Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16

    Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is calculated as serum iron/ total iron-binding capacity x 100. Mean values of transferrin saturation at Baseline (Week 0), Week 4, Week 10, and Week 16 are presented.

  17. Mean Serum Albumin Over Time

    Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16

    Mean values of serum albumin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  18. Mean Serum Globulin Over Time

    Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16

    Mean values of serum globulin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  19. Mean Serum Creatinine Over Time

    Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16

    Mean values of serum creatinine are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  20. Mean Blood Urea Nitrogen Over Time

    Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16

    Mean values of blood urea nitrogen (BUN) are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  21. Mean Serum Potassium Over Time

    Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16

    Mean values of serum potassium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  22. Mean Serum Sodium Over Time

    Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16

    Mean values of serum sodium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  23. Mean Serum Phosphate Over Time

    Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16

    Mean values of serum phosphate are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  24. Mean Serum Bilirubin Over Time

    Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16

    Mean values of serum bilirubin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  25. Mean Aspartate Transaminase Over Time

    Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16

    Mean values of aspartate transaminase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  26. Mean Alanine Aminotransferase Over Time

    Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16

    Mean values of alanine aminotransferase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

  27. Mean Serum Alkaline Phosphatase Over Time

    Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16

    Mean values of serum alkaline phosphatase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.

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 Two Weekly Administration of Intravenous Methoxy Polyethylene Glycol-epoetin Beta (MIRCERA) for the Treatment of Chronic Renal Anemia in Dialysis Patients Not Currently Treated With Erythropoietin-stimulating Agent (ESA).

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 19, 2008
Registry last updated
Jun 2, 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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