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Completed

NCT Number: NCT00737464

A Study of Once Monthly Intravenous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.

This single arm study will evaluate the maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in dialysis patients with chronic renal anemia. Patients will receive intravenous Mircera (120, 200 or 360 micrograms) every four weeks depending on the previous dose of epoetin alfa administered in the week preceding first study drug administration. Patients will be treated for 12 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

Indraprastha Apollo Hospitals, New Delhi, National Capital Territory of Delhi, India

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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 10.5g/dL - 12.5g/dL;
  • continuous intravenous maintenance therapy with epoetin alfa at the same dosing interval during the previous 2 months.

Exclusion criteria

  • blood transfusion within the previous 2 months;
  • 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 (120, 200 or 360 micrograms) every 4 weeks for 12 weeks.

Primary outcomes

  1. Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12)

    Time frame: Weeks 8 to 12 (Last 4 weeks of treatment period)

    Participants maintaining mean hemoglobin (Hb) concentration within the target range i.e. 10.0 - 12.0 gram per deciliter (g/dL) during last 4 weeks (Weeks 8 to 12) of treatment period (TP) were reported. Total duration for treatment period was 12 weeks. Stability verification period of 2-weeks was conducted before treatment period. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value Hb +/- 1 g/dL but not >12.0 g/dL and not <10.0 g/dL.

Secondary outcomes

  1. Mean Hemoglobin Concentration Between Stability Verification Period (Weeks -2 to -1) and Treatment Period (Weeks 8 to 12)

    Time frame: SVP (Weeks -2 to -1) and TP (Weeks 8 to 12)

    The mean change in Hb concentration between reference stability verification period (SVP) and in last 4 weeks (Weeks 8 to 12) of treatment period (TP) was reported. Duration for SVP was 2 weeks followed by treatment period of 12 weeks. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 g/dL but not >12.0 g/dL and not <10.0 g/dL.

  2. Mean Time Participants Spent Having Hemoglobin Range of 10.0 to 12.0 g/dL

    Time frame: Up to Week 12

    Mean time participants spent having hemoglobin range of 10.0 to 12.0 g/dL was reported. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 gram per deciliter but not >12.0 g/dL and not <10.0 g/dL.

  3. Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Deaths

    Time frame: Up to Week 14

    Participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and deaths in the overall study were reported. An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

  4. Mean Change From Baseline in Heart Rate Over Time

    Time frame: From Baseline (Week -1) to Weeks 0, 1, 2, 4, 6, 8, 10, and 12

    Mean change from Baseline (Week -1) to end of the treatment (Week 12) in heart rate was reported. Baseline measure was considered as (Week -1) evaluation for this parameter.

  5. Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time

    Time frame: From Baseline (Week -2) to Weeks -1, 0, 1, 2, 4, 6, 8, 10, and 12

    Mean change from Baseline (Week -2) to end of the treatment (Week 12) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) before and after dialysis was reported. Baseline measure was considered as (Week -2) evaluation for this parameter.

  6. Number of Participants With Abnormal Electrocardiogram

    Time frame: At Week -2 and Week 12

    Participants with abnormal electrocardiogram were reported.

  7. Mean Values of White Blood Cells and Platelets Over Time

    Time frame: At Weeks -2, 4, 8, and 12

    Mean values of white blood cells (WBCs), and platelets at Weeks -2, 4, 8, and 12 were reported.

  8. Mean Values of Hypochromic Red Blood Cells Over Time

    Time frame: At Weeks -2, 4, 8, and 12

    Mean values of hypochromic red blood cells (RBCs) at Weeks -2, 4, 8, and 12 were reported.

  9. Mean Corpuscular Volume Levels Over Time

    Time frame: At Weeks -2, 4, 8, and 12

    Mean corpuscular volume (MCV) is a measure of the average red blood cell volume. MCV levels at Weeks -2, 4, 8, and 12 were reported.

  10. Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time

    Time frame: At Weeks -2, 4, 8, and 12

    Mean values of serum iron and total iron binding capacity (TIBC) were reported.

  11. Mean Values of Serum Ferritin Over Time

    Time frame: At Weeks -2, 4, 8, and 12

    Mean values of serum ferritin were reported.

  12. Mean Values of Transferrin Over Time

    Time frame: At Weeks -2, 4, 8, and 12

    Mean values of transferrin were reported.

  13. Mean Values of Transferrin Saturation Over Time

    Time frame: At Weeks -2, 4, 8, and 12

    Mean values of Transferrin Saturation (TSAT) were reported.

  14. Mean Values of Serum Albumin and Serum Globulin Over Time

    Time frame: At Weeks -2, 4, 8, and 12

    Mean values of serum albumin and serum globulin were reported.

  15. Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time

    Time frame: At Weeks -2, 4, 8, and 12

    Mean values of aspartate aminotransferase (AST), alanine transaminase (ALT) and serum alkaline phosphatase were reported.

  16. Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time

    Time frame: At Weeks -2, 4, 8, and 12

    Mean values of serum creatinine, blood urea nitrogen (BUN), serum phosphate and serum bilirubin were reported.

  17. Mean Values of Serum Sodium and Serum Potassium Over Time

    Time frame: At Weeks -2, 4, 8, and 12

    Mean values of serum sodium and serum potassium were 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 MIRCERA for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 19, 2008
Registry last updated
Dec 7, 2017

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

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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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