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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00737464
First received: August 18, 2008
Last updated: March 30, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Anemia
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.

  • Mean Time Participants Spent Having Hemoglobin Range of 10.0 to 12.0 g/dL [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Deaths [ Time Frame: Up to Week 14 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Abnormal Electrocardiogram [ Time Frame: At Week -2 and Week 12 ] [ Designated as safety issue: No ]
    Participants with abnormal electrocardiogram were reported.

  • Mean Values of White Blood Cells and Platelets Over Time [ Time Frame: At Weeks -2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    Mean values of white blood cells (WBCs), and platelets at Weeks -2, 4, 8, and 12 were reported.

  • Mean Values of Hypochromic Red Blood Cells Over Time [ Time Frame: At Weeks -2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    Mean values of hypochromic red blood cells (RBCs) at Weeks -2, 4, 8, and 12 were reported.

  • Mean Corpuscular Volume Levels Over Time [ Time Frame: At Weeks -2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    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.

  • Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time [ Time Frame: At Weeks -2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    Mean values of serum iron and total iron binding capacity (TIBC) were reported.

  • Mean Values of Serum Ferritin Over Time [ Time Frame: At Weeks -2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    Mean values of serum ferritin were reported.

  • Mean Values of Transferrin Over Time [ Time Frame: At Weeks -2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    Mean values of transferrin were reported.

  • Mean Values of Transferrin Saturation Over Time [ Time Frame: At Weeks -2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    Mean values of Transferrin Saturation (TSAT) were reported.

  • Mean Values of Serum Albumin and Serum Globulin Over Time [ Time Frame: At Weeks -2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    Mean values of serum albumin and serum globulin were reported.

  • Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time [ Time Frame: At Weeks -2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    Mean values of aspartate aminotransferase (AST), alanine transaminase (ALT) and serum alkaline phosphatase were reported.

  • Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time [ Time Frame: At Weeks -2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    Mean values of serum creatinine, blood urea nitrogen (BUN), serum phosphate and serum bilirubin were reported.

  • Mean Values of Serum Sodium and Serum Potassium Over Time [ Time Frame: At Weeks -2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    Mean values of serum sodium and serum potassium were reported.


Enrollment: 132
Study Start Date: August 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mircera
Participant with chronic renal anemia will receive methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
iv (120, 200 or 360 micrograms) every 4 weeks for 12 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737464

Locations
India
Bangalore, India, 560017
Bangalore, India, 560024
Chennai, India, 600 037
Chennai, India, 6000089
Chennai, India, 600037
Guwahati, India, 781005
Hyderabad, India, 500068
Hyderabad, India, 500082
Kanpur, India, 208005
Kolkata, India, 700029
Meerut, India, 250001
Mohali, India, 160 063
Mumbai, India, 400080
Mumbai, India, 400092
New Delhi, India, 110070
New Delhi, India, 110076
Pune, India, 411 001
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00737464     History of Changes
Other Study ID Numbers: ML21810 
Study First Received: August 18, 2008
Results First Received: February 25, 2016
Last Updated: March 30, 2016
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics

ClinicalTrials.gov processed this record on September 26, 2016