A Study for Monthly Methoxy Polyethylene Glycol-Epoetin Beta Treatment in Patients With Chronic Renal Anaemia
|ClinicalTrials.gov Identifier: NCT01066000|
Recruitment Status : Terminated
First Posted : February 10, 2010
Results First Posted : May 13, 2016
Last Update Posted : November 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Anemia||Drug: methoxy polyethylene glycol-epoetin beta [Mircera]||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||October 31, 2009|
|Actual Primary Completion Date :||September 30, 2011|
|Actual Study Completion Date :||September 30, 2011|
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
initial doses of either 120 micrograms or 200 micrograms or 360 micrograms, once monthly
- 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 ]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.
- Number of Participants With Adverse Events and Serious Adverse Events [ Time Frame: 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.
- Mean Change in Haemoglobin Concentration From Screening Period and Efficacy Evaluation Period [ Time Frame: 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.
- Proportion of Participants Maintaining Haemoglobin Concentration Within the Haemoglobin Range 10-12g/dL Throughout the Efficacy Evaluation Period [ Time Frame: 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 Time Spent by Participants in the Haemoglobin Range of 10 - 12 g/dL During the Efficacy Evaluation Period [ Time Frame: 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 Number of Months Per Participant Requiring Dose Adjustment During the Dose Titration and Evaluation Periods [ Time Frame: Up to Week 24 ]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 ]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 ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01066000
|Advent Hospital; Kidney and Hipertension|
|Bandung, Indonesia, 40131|
|Sanglah Hospital; Kidney and Hipertension|
|Denpasar, Indonesia, 80114|
|Rumah Sakit Pgi Cikini; Renal & Hypertension|
|Jakarta, Indonesia, 10330|
|Cipto Mangunkusumo Hospital; Renal and Hypertension division, Internal Medecine Department|
|Jakarta, Indonesia, 10440|
|Pelni Hospital; Kidney and Hipertension|
|Jakarta, Indonesia, 11410|
|Pondok Indah Hospital; Kidney and Hipertension|
|Jakarta, Indonesia, 12310|
|Pantai Indah Kapuk Hospital; Kidney and Hipertension|
|Jakarta, Indonesia, 14460|
|Klinik Spesialis Ginjal dan hipertensi Rasyida; Renal and Hypertension|
|Medan, Indonesia, 20119|
|Pirngadi; Renal and Hypertension|
|Medan, Indonesia, 20234|
|Telogorejo Hospital; Renal and Hypertension|
|Semarang, Indonesia, 50136|
|Dokter Soetomo Hospital|
|Surabaya, Indonesia, 60286|
|PHC Hospital; Renal and Hypertension|
|Surabaya, Indonesia, 60286|
|Study Director:||Clinical Trials||Hoffmann-La Roche|