A Study of Two-Weekly Intravenous Mircera for the Treatment of Dialysis Patients With Chronic Renal Anemia Not Receiving ESA Therapy.

A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Two Weekly Administration of Intravenous Methoxy Polyethylene Glycol-epoetin Beta (MIRCERA) for the Treatment of Chronic Renal Anemia in Dialysis Patients Not Currently Treated With Erythropoietin-stimulating Agent (ESA).

This single arm study will evaluate the hemoglobin (Hb) increasing effect, safety and tolerability of two-weekly intravenous administration of Mircera in dialysis patients with chronic renal anemia not currently treated with ESAs. Patients will receive intravenous Mircera 0.6 micrograms/kg every 2 weeks for 16 weeks with follow up 2 weeks after the last treatment visit. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 189
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Ahmedabad, India, 380007
  • Bangalore, India, 560034
  • Chennai, India, 603103
  • Coimbatore, India, 641004
  • Gujarat, India, 387 001
  • Hyderabad, India, 500001
  • Kerala, India, 682017
  • Kolkata, India, 700099
  • Ludhiana, India
  • Mumbai, India
  • Mumbai, India, 400026
  • New Delhi, India, 110 060
  • New Delhi, India, 110017
  • New Delhi, India, 110026
  • Vellore, India, 632 004
  • Vishakpatnam, India, 530002

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:

• male or female patients, >=18 years of age;
• chronic renal anemia (Hb concentration 8.0g/dL - 10.0g/dL);
• no prior erythropoietin stimulating agent (ESA) therapy.

Exclusion Criteria:

• blood transfusion within the previous 4 weeks;
• poorly controlled hypertension;
• significant acute or chronic bleeding;
• active malignant disease;
• congestive heart failure (NYHA Class IV).

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]; iv 0.6 micrograms/kg every 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period	The difference between the mean Hemoglobin (Hb) value at the last visit (Week 16) of the treatment period (TP) and at Baseline (Week 0) is presented. TP was from Baseline to Week 16.	Baseline (Week 0) and Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter	Achievement of blood Hb levels within target range of 10.0-12.0 g/dL was considered as achievement of response. The mean time required to achieve the Hb target range is presented in weeks.	Up to Week 16
Mean Time Spent in the Hemoglobin Range of 10.0-12.0 Gram/Deciliter From Week 12 to Week 16	The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The mean time spent (in weeks) by the participants in the target range (10-12 g/dL) during the last 4 weeks of the TP is presented.	Week 12 to Week 16
Percentage of Participants With Average Hemoglobin Concentration Between 10.0-12.0 Gram/Deciliter From Week 12 to Week 16	The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The percentage of participants achieving Hb levels within target range of 10.0-12.0 g/dL during the last 4 weeks of the TP is presented.	Week 12 to Week 16
Number of Participants With Adverse Events, Serious Adverse Events and Deaths	An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. An SAE is any AE that can result in death or is life-threatening or required participant hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above	Up to Week 18
Number of Participants With Abnormal Electrocardiogram	Twelve-lead electrocardiogram (ECG) was recorded for the participants. The number of participants with abnormal ECG is presented.	Up to Week 16
Number of Participants With Reports of Blood Transfusions	Indications for blood transfusions were acute blood loss (bleeding), lack of treatment response or treatment failure, or other reasons.	Up to Week 16
Number of Participants With Reports of Anti-Epoetin Antibodies	Participants were assessed for the presence of Anti-Epoetin antibodies for MIRCERA.	Up to Week 16
Mean White Blood Cell Count Over Time	The mean values of white blood cells are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.	Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Value of Mean Corpuscular Volume Over Time	Mean corpuscular volume (MCV) is a measure of the average volume of red blood corpuscles (RBCs) and is calculated by dividing hematocrit value by the concentration of RBCs. Mean values of MCV are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. Reference range of mean corpuscular volume is 80-96 femtoliter (fL) per red blood cell.	Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Hypochromic Red Blood Cells Over Time	Mean values of hypochromic RBCs are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.	Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Platelet Count Over Time	Mean values of platelet count are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.	Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Iron Over Time	Mean values of serum iron are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.	Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Ferritin Over Time	Mean values of serum ferritin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.	Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Transferrin Over Time	Mean values of serum transferrin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.	Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Total Iron-binding Capacity Over Time	Mean values of total iron-binding capacity are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.	Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Transferrin Saturation Over Time	Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is calculated as serum iron/ total iron-binding capacity x 100. Mean values of transferrin saturation at Baseline (Week 0), Week 4, Week 10, and Week 16 are presented.	Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Albumin Over Time	Mean values of serum albumin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.	Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Globulin Over Time	Mean values of serum globulin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.	Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Creatinine Over Time	Mean values of serum creatinine are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.	Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Blood Urea Nitrogen Over Time	Mean values of blood urea nitrogen (BUN) are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.	Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Potassium Over Time	Mean values of serum potassium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.	Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Sodium Over Time	Mean values of serum sodium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.	Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Phosphate Over Time	Mean values of serum phosphate are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.	Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Bilirubin Over Time	Mean values of serum bilirubin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.	Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Aspartate Transaminase Over Time	Mean values of aspartate transaminase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.	Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Alanine Aminotransferase Over Time	Mean values of alanine aminotransferase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.	Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Alkaline Phosphatase Over Time	Mean values of serum alkaline phosphatase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.	Baseline (Week 0), Week 4, Week 10, and Week 16

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (ACTUAL): October 1, 2009
• Study Completion (ACTUAL): October 1, 2009

Study Registration Dates

• First Submitted: August 18, 2008
• First Submitted That Met QC Criteria: August 18, 2008
• First Posted (ESTIMATE): August 19, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): June 2, 2016
• Last Update Submitted That Met QC Criteria: April 26, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: ML21822