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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01066000
• Other study ID #: ML21736
• Status: Terminated
• Phase: Phase 4
• First received: February 9, 2010
• Last updated: November 2, 2017
• Start date: October 31, 2009
• Est. completion date: September 30, 2011

Study information

• Verified date: November 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: September 30, 2011
• Est. primary completion date: September 30, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• methoxy polyethylene glycol-epoetin beta [Mircera]
initial doses of either 120 micrograms or 200 micrograms or 360 micrograms, once monthly

Locations

Country	Name	City	State
Indonesia	Advent Hospital; Kidney and Hipertension	Bandung
Indonesia	Sanglah Hospital; Kidney and Hipertension	Denpasar
Indonesia	Cipto Mangunkusumo Hospital; Renal and Hypertension division, Internal Medecine Department	Jakarta
Indonesia	Pantai Indah Kapuk Hospital; Kidney and Hipertension	Jakarta
Indonesia	Pelni Hospital; Kidney and Hipertension	Jakarta
Indonesia	Pondok Indah Hospital; Kidney and Hipertension	Jakarta
Indonesia	Rumah Sakit Pgi Cikini; Renal & Hypertension	Jakarta
Indonesia	Klinik Spesialis Ginjal dan hipertensi Rasyida; Renal and Hypertension	Medan
Indonesia	Pirngadi; Renal and Hypertension	Medan
Indonesia	Telogorejo Hospital; Renal and Hypertension	Semarang
Indonesia	Dokter Soetomo Hospital	Surabaya
Indonesia	PHC Hospital; Renal and Hypertension	Surabaya

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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