A Study for Monthly Methoxy Polyethylene Glycol-Epoetin Beta Treatment in Patients With Chronic Renal Anaemia

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01066000
First received: February 9, 2010
Last updated: April 11, 2016
Last verified: April 2016

February 9, 2010
April 11, 2016
October 2009
September 2011   (final data collection date for primary outcome measure)
Proportion of Participants Maintaining Average Haemoglobin During the Efficacy Evaluation Period Within the Target Range (10-12 g/dl) [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
The proportion of participants with their mean haemoglobin (Hb) concentration (g/dL) within the target range during the efficacy evaluation period was assessed. The target range is the reference Hb not >12 g/dL and not < 10 g/dL.
Long-term maintenance of haemoglobin levels [ Time Frame: Throughout study, weeks 1 and 2 and every 2 weeks thereafter ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01066000 on ClinicalTrials.gov Archive Site
  • Number of Participants With Adverse Events and Serious Adverse Events [ Time Frame: Up to Week 28 ] [ Designated as safety issue: No ]
    An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. The AEs were assessed from baseline to every visit throughout the treatment, post study drug discontinuation, and follow up period.
  • Mean Change in Haemoglobin Concentration From Screening Period and Efficacy Evaluation Period [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    The mean haemoglobin (Hb) concentration (g/dL) change from the baseline (Week 0) till efficacy evaluation period (EEP) was assessed and reported.
  • Proportion of Participants Maintaining Haemoglobin Concentration Within the Haemoglobin Range 10-12g/dL Throughout the Efficacy Evaluation Period [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    The proportion of participants maintaining haemoglobin concentration within the haemoglobin range 10-12g/dL throughout the efficacy evaluation period (EEP) was assessed and reported.
  • Mean Time Spent by Participants in the Haemoglobin Range of 10 - 12 g/dL During the Efficacy Evaluation Period [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    Mean time spent in the haemoglobin range 10 - 12 g/dL during the efficacy evaluation period (EEP) was assessed and reported.
  • Mean Number of Months Per Participant Requiring Dose Adjustment During the Dose Titration and Evaluation Periods [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    Mean number of months per participant requiring dose adjustment during the dose titration and evaluation periods was assessed and reported.
  • Mean Monthly Dose of Methoxy Polyethylene Glycol-epoetin Beta During the Dose Titration and Evaluation Periods [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16, and Week 20 ] [ Designated as safety issue: No ]
    Mean monthly dose of methoxy polyethylene glycol-epoetin beta during the dose titration and evaluation periods was assessed and reported.
  • Number of Participants With Marked Laboratory Abnormalities [ Time Frame: Up to Week 28 ] [ Designated as safety issue: No ]
    A marked laboratory abnormality is defined as above and/or below the normal range of a laboratory parameter which was considered to be potentially clinically relevant. The number of participants with marked laboratory abnormality are presented. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the following reference range: Haemoglobin (Hb) (11.7-17.3 g/dL), Haematocrit (Hct) (35-47%), White blood cells (WBC) (3.6-11.0 10^3/µL), Red blood cells (RBC) (3.8- 5.9 10^6/µL), MCV (80-100 fL) Platelets (150-440 10^3/µL), Iron (37-158 µg/dL), Ferritin (10-365 ng/mL), Transferrin (170-340 mg/dL), TIBC (250-450 µg/dL), TSAT (15-50%), Albumin (3.4-4.8 g/dL), hs-CRP (<= 10.000 mg/dL), Potassium (3.5-5.1 mmol/L), and Phosphorus (2.7-4.5 mg/dL).
Safety and Tolerability: AEs, laboratory parameters [ Time Frame: Laboratory parameters: throughout study, weeks 1 and 2 and every 2 weeks thereafter ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study for Monthly Methoxy Polyethylene Glycol-Epoetin Beta Treatment in Patients With Chronic Renal Anaemia
A Single Arm Open Label Interventional Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous Methoxy-polyethylene Glycol-epoetin Beta for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia
This open-label single-arm study will evaluate the efficacy, safety and tolerability of methoxy polyethylene glycol epoetin beta on long-term maintenance of haemoglobin levels in patients with chronic renal anaemia. Patients will receive methoxy polyethylene glycol-epoetin beta intravenously once monthly at initial doses of either 120 micrograms or 200 micrograms or 360 micrograms in the titration phase of 16 weeks with a potential dose adjustment in the evaluation phase of 8 weeks. The anticipated time on study treatment is 24 weeks. The target sample size is 50-100 patients.
Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Anemia
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
initial doses of either 120 micrograms or 200 micrograms or 360 micrograms, once monthly
Experimental: Mircera
Intervention: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
33
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults >/=18 years of age
  • Chronic renal anaemia
  • Haemoglobin concentration between 10 and 12 g/dL at screening
  • Adequate iron status
  • Continuous intravenous maintenance short-acting therapy with same dosing interval for 8 weeks prior to screening
  • Regular long-term haemodialysis therapy for at least 12 weeks prior to screening

Exclusion Criteria:

  • Change in haemoglobin concentration >/=2 g/dL during screening
  • Transfusion of red blood cells less than 8 weeks prior to screening
  • Poorly controlled hypertension
  • Relevant acute or chronic bleeding requiring treatment less than 8 weeks prior to screening
  • Active malignant disease
  • Haemolysis
  • Haemoglobinopathies
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Indonesia
 
NCT01066000
ML21736
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP