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
  Purpose
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.

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 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 33
Study Start Date: October 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mircera Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
initial doses of either 120 micrograms or 200 micrograms or 360 micrograms, once monthly

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01066000

Locations
Indonesia
Bandung, Indonesia, 40131
Denpasar, Indonesia, 80114
Jakarta, Indonesia, 12310
Jakarta, Indonesia, 10440
Jakarta, Indonesia, 11410
Jakarta, Indonesia, 14460
Jakarta, Indonesia, 10330
Medan, Indonesia, 20119
Medan, Indonesia, 20234
Semarang, Indonesia, 50136
Surabaya, Indonesia, 60286
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01066000     History of Changes
Other Study ID Numbers: ML21736 
Study First Received: February 9, 2010
Results First Received: February 18, 2016
Last Updated: April 11, 2016
Health Authority: Indonesia: Badan Pengawas Obat dan Makanan Republik Indonesia (BPOM RI)

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on May 25, 2016