Clinical trial NCT01066000: A Study for Monthly Methoxy Polyethylene Glycol-Epoetin Beta Treatment in Patients With Chronic Renal Anaemia
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-02-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Proportion of Participants Maintaining Average Haemoglobin During the Efficacy Evaluation Period Within the Target Range (10-12 g/dl)
timeFrame: Up to Week 24
Secondary outcomes:
measure: Number of Participants With Adverse Events and Serious Adverse Events
timeFrame: Up to Week 28
measure: Mean Change in Haemoglobin Concentration From Screening Period and Efficacy Evaluation Period
timeFrame: Up to Week 24
measure: Proportion of Participants Maintaining Haemoglobin Concentration Within the Haemoglobin Range 10-12g/dL Throughout the Efficacy Evaluation Period
timeFrame: Up to Week 24
measure: Mean Time Spent by Participants in the Haemoglobin Range of 10 - 12 g/dL During the Efficacy Evaluation Period
timeFrame: Up to Week 24
measure: Mean Number of Months Per Participant Requiring Dose Adjustment During the Dose Titration and Evaluation Periods
timeFrame: Up to Week 24
measure: Mean Monthly Dose of Methoxy Polyethylene Glycol-epoetin Beta During the Dose Titration and Evaluation Periods
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16, and Week 20
measure: Number of Participants With Marked Laboratory Abnormalities
timeFrame: Up to Week 28
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Advent Hospital; Kidney and Hipertension
city: Denpasar
country: Indonesia
facility: Sanglah Hospital; Kidney and Hipertension
city: Jakarta
country: Indonesia
facility: Rumah Sakit Pgi Cikini; Renal & Hypertension
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Hospital; Renal and Hypertension division, Internal Medecine Department
city: Jakarta
country: Indonesia
facility: Pelni Hospital; Kidney and Hipertension
city: Jakarta
country: Indonesia
facility: Pondok Indah Hospital; Kidney and Hipertension
city: Jakarta
country: Indonesia
facility: Pantai Indah Kapuk Hospital; Kidney and Hipertension
city: Medan
country: Indonesia
facility: Klinik Spesialis Ginjal dan hipertensi Rasyida; Renal and Hypertension
city: Medan
country: Indonesia
facility: Pirngadi; Renal and Hypertension
city: Semarang
country: Indonesia
facility: Telogorejo Hospital; Renal and Hypertension
city: Surabaya
country: Indonesia
facility: Dokter Soetomo Hospital
city: Surabaya
country: Indonesia
facility: PHC Hospital; Renal and Hypertension
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: