Clinical trial NCT00922116: A Study of Once Monthly Subcutaneous Mircera in Patients With Chronic Renal Anemia Not on Dialysis
Official title: A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous Mircera® for the Maintenance of Haemoglobin Levels in Patients With Chronic Renal Anaemia Who Are Not on Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-06-17
Enrollment: 191
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 single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in patients with chronic renal anemia not on dialysis.Patients will receive sc Mircera at a starting dose of 100, 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of ESA previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic renal anemia;
* continuous maintenance ESA therapy with the same dosing interval during the previous month, and no change in totally weekly dose.

Exclusion Criteria:

* transfusion of red blood cells during previous 2 months;
* poorly controlled hypertension;
* significant acute or chronic bleeding;
* active malignant disease (except non-melanoma skin cancer).

Primary outcomes:
measure: Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP)
timeFrame: EEP (Weeks 17 to 24)
Secondary outcomes:
measure: Change in Hemoglobin Concentration Between SVP and the EEP
timeFrame: SVP (Baseline), and EEP (Weeks 17 to 24)
measure: Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 10.0 to 12.0 g/dL Throughout the EEP
timeFrame: EEP (Weeks 17 to 24)
measure: Percentage of Participants Who Required Dose Adjustments During Dose Titration Period (DTP) and EEP
timeFrame: Weeks 1 to 24
measure: Time Spent in Hemoglobin Range of 10.0 to 12.0 g/dL During DTP and EEP
timeFrame: Weeks 1 to 24
measure: Average Dose of Mircera Per Month
timeFrame: Weeks 0-4, 4-8, 8-12, 12-16, 16-20, and 20-24
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital; Nephrology
city: Daegu
country: Korea, Republic of
facility: Kyungpook National Uni Hospital; Internal Medicine
city: Daejeon
country: Korea, Republic of
facility: Chungnam National Uni Hospital; Nephrology
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Kyonggi-do
country: Korea, Republic of
facility: NHIC Ilsan Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National Uni Hospital; Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital; Division of Nephrology
city: Seoul
country: Korea, Republic of
facility: East-West Neo Medical Center; Division Of Nephology
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Centre; Department of Hematology & Oncology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: