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.

Study Overview

• Status: Terminated
• Conditions: Anemia
• Intervention / Treatment: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 4

Contacts and Locations

Study Locations

• Indonesia
  • Bandung, Indonesia, 40131
    • Advent Hospital; Kidney and Hipertension
  • Denpasar, Indonesia, 80114
    • Sanglah Hospital; Kidney and Hipertension
  • Jakarta, Indonesia, 10330
    • Rumah Sakit Pgi Cikini; Renal & Hypertension
  • Jakarta, Indonesia, 10440
    • Cipto Mangunkusumo Hospital; Renal and Hypertension division, Internal Medecine Department
  • Jakarta, Indonesia, 11410
    • Pelni Hospital; Kidney and Hipertension
  • Jakarta, Indonesia, 12310
    • Pondok Indah Hospital; Kidney and Hipertension
  • Jakarta, Indonesia, 14460
    • Pantai Indah Kapuk Hospital; Kidney and Hipertension
  • Medan, Indonesia, 20119
    • Klinik Spesialis Ginjal dan hipertensi Rasyida; Renal and Hypertension
  • Medan, Indonesia, 20234
    • Pirngadi; Renal and Hypertension
  • Semarang, Indonesia, 50136
    • Telogorejo Hospital; Renal and Hypertension
  • Surabaya, Indonesia, 60286
    • Dokter Soetomo Hospital
  • Surabaya, Indonesia, 60286
    • PHC Hospital; Renal and Hypertension

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mircera	Drug: methoxy polyethylene glycol-epoetin beta [Mircera]; initial doses of either 120 micrograms or 200 micrograms or 360 micrograms, once monthly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Maintaining Average Haemoglobin During the Efficacy Evaluation Period Within the Target Range (10-12 g/dl)	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.	Up to Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events and Serious Adverse Events	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.	Up to Week 28
Mean Change in Haemoglobin Concentration From Screening Period and Efficacy Evaluation Period	The mean haemoglobin (Hb) concentration (g/dL) change from the baseline (Week 0) till efficacy evaluation period (EEP) was assessed and reported.	Up to Week 24
Proportion of Participants Maintaining Haemoglobin Concentration Within the Haemoglobin Range 10-12g/dL Throughout the Efficacy Evaluation Period	The proportion of participants maintaining haemoglobin concentration within the haemoglobin range 10-12g/dL throughout the efficacy evaluation period (EEP) was assessed and reported.	Up to Week 24
Mean Time Spent by Participants in the Haemoglobin Range of 10 - 12 g/dL During the Efficacy Evaluation Period	Mean time spent in the haemoglobin range 10 - 12 g/dL during the efficacy evaluation period (EEP) was assessed and reported.	Up to Week 24
Mean Number of Months Per Participant Requiring Dose Adjustment During the Dose Titration and Evaluation Periods	Mean number of months per participant requiring dose adjustment during the dose titration and evaluation periods was assessed and reported.	Up to Week 24
Mean Monthly Dose of Methoxy Polyethylene Glycol-epoetin Beta During the Dose Titration and Evaluation Periods	Mean monthly dose of methoxy polyethylene glycol-epoetin beta during the dose titration and evaluation periods was assessed and reported.	Baseline, Week 4, Week 8, Week 12, Week 16, and Week 20
Number of Participants With Marked Laboratory Abnormalities	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).	Up to Week 28

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 31, 2009
• Primary Completion (ACTUAL): September 30, 2011
• Study Completion (ACTUAL): September 30, 2011

Study Registration Dates

• First Submitted: February 9, 2010
• First Submitted That Met QC Criteria: February 9, 2010
• First Posted (ESTIMATE): February 10, 2010

Study Record Updates

• Last Update Posted (ACTUAL): November 13, 2017
• Last Update Submitted That Met QC Criteria: November 2, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: ML21736