Clinical trial NCT00882713: A Study of Once Monthly Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia
Official title: A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once- Monthly Administration of Subcutaneous CERA for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-04-16
Enrollment: 202
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 dialysis patients with chronic renal anemia. Patients will receive subcutaneous Mircera at a starting dose of 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of epoetin or darbepoetin alfa previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. Treatment duration is 56 weeks, and the target sample size is 200 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic renal anemia;
* regular long-term hemodialysis or peritoneal dialysis, with same mode of dialysis for \>=3 months;
* continuous iv maintenance epoetin alfa therapy with same dosing interval during previous 2 months.

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 Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period
timeFrame: EEP (Week 17 to Week 24)
Secondary outcomes:
measure: Mean Change in Hemoglobin Concentration Between Reference (Stability Verification Period) and the Efficacy Evaluation Period
timeFrame: SVP (Weeks -3, -2, -1) and EEP (Week 17 to Week 24)
measure: Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.5-12.5 g/dL Throughout the EEP
timeFrame: EEP (Week 17 to Week 24)
measure: Mean Time Spent By Participants With Hemoglobin Range of 10.5-12.5 g/dL During the EEP
timeFrame: EEP (Week 17 to Week 24)
measure: Number of Participants With Any Adverse Events or Serious Adverse Events
timeFrame: Up to Week 52
measure: Percentage of Participants Requiring Any Dose Adjustment During DTP and EEP
timeFrame: DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24)
measure: Incidences of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase
timeFrame: Up to Week 52
measure: Mean Hemoglobin Levels Over Time
timeFrame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
measure: Mean Hematocrit Levels Over Time
timeFrame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
measure: Mean Albumin Levels Over Time
timeFrame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
measure: Mean White Blood Cells and Thrombocytes Over Time
timeFrame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
measure: Mean Phosphate and Potassium Levels Over Time
timeFrame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
measure: Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
timeFrame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
measure: Mean C-Reactive Protein Levels Over Time
timeFrame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
measure: Mean Ferritin Levels Over Time
timeFrame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
measure: Mean Transferrin Saturation Levels Over Time
timeFrame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
measure: Mean Change From Baseline in Pulse Rate Over Time
timeFrame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
measure: Mean Change From Baseline in Blood Pressure Over Time
timeFrame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
measure: Mean Change From Baseline in Weight Over Time
timeFrame: Week 16 and Week 48
Other outcomes:
Locations:
city: Agadir
country: Morocco
city: Casablanca
country: Morocco
city: Casablanca
country: Morocco
city: Casablanca
country: Morocco
city: FÉS
country: Morocco
city: Khouribga
country: Morocco
city: Marrakech
country: Morocco
city: Méknés
country: Morocco
city: Rabat
country: Morocco
city: Rabat
country: Morocco
city: Salé
country: Morocco
city: Tanger
country: Morocco
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10.