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

Phase 4

Terminated

• Conditions: Anemia
• Interventions: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

• Registration Number: NCT01066000
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-31
• Study First Submitted: 2010-02-09
• Study First Submitted QC: 2010-02-09
• Study First Posted: 2010-02-10
• Primary Completion: 2011-09-30
• Study Completion: 2011-09-30
• Results First Submitted: 2016-02-18
• Results First Submitted QC: 2016-04-11
• Results First Posted: 2016-05-13
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-02
• Last Update Posted: 2017-11-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mircera	methoxy polyethylene glycol-epoetin beta [Mircera]	-

Primary Outcome Measures

Name	Time	Method
Proportion of Participants Maintaining Average Haemoglobin During the Efficacy Evaluation Period Within the Target Range (10-12 g/dl)	Up to Week 24	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

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

Trial Locations

Locations (12)

Advent Hospital; Kidney and Hipertension; 🇮🇩 Bandung, Indonesia

Sanglah Hospital; Kidney and Hipertension; 🇮🇩 Denpasar, Indonesia

Rumah Sakit Pgi Cikini; Renal & Hypertension; 🇮🇩 Jakarta, Indonesia

Cipto Mangunkusumo Hospital; Renal and Hypertension division, Internal Medecine Department; 🇮🇩 Jakarta, Indonesia

Pelni Hospital; Kidney and Hipertension; 🇮🇩 Jakarta, Indonesia

Pondok Indah Hospital; Kidney and Hipertension; 🇮🇩 Jakarta, Indonesia

Pantai Indah Kapuk Hospital; Kidney and Hipertension; 🇮🇩 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, Indonesia