Clinical trial NCT00560404: A Study of Subcutaneous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
Official title: A Randomized, Open Label Study to Compare the Effect of Once Monthly Administration of Subcutaneous Mircera Versus Epoetin Alfa on Maintenance of Hemoglobin Levels, Safety and Tolerability 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: 2007-11-19
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 2 arm study will compare the efficacy and safety of monthly administration of subcutaneous Mircera versus epoetin alfa for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with epoetin alfa will be randomized to receive either monthly injections of Mircera with a starting dose (120, 200 or 360 micrograms) derived from the dose of epoetin alfa they were receiving in the week preceding study start, or to continue on epoetin alfa treatment. 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;
* regular hemodialysis with the same schedule of dialysis for \>=12 weeks;
* maintenance therapy with subcutaneous epoetin alfa at the same administration interval for 4 weeks.

Exclusion Criteria:

* transfusion of red blood cells during previous 2 months;
* poorly controlled hypertension requiring interruption of epoetin alfa in previous 6 months;
* acute or chronic bleeding;
* active malignant disease (except non-melanoma skin cancer).

Primary outcomes:
measure: Percentage of Participants Maintaining Their Mean Hemoglobin Concentration Within Plus or Minus 1 Gram/Deciliter of Their Reference Hemoglobin and Between the Target Range During Efficacy Evaluation Period
timeFrame: EEP (Week 29 to Week 36)
Secondary outcomes:
measure: Mean Change From Baseline in Hemoglobin Concentration Between Baseline and at the Efficacy Evaluation Period
timeFrame: Baseline (Weeks -4 to 0) and at EEP (Weeks 29 to 36)
measure: Percentage of Participants Maintaining Individual Hemoglobin Concentration Within the Range of 10.5 - 12.5 Gram/Decilitre Throughout the Efficacy Evaluation Period
timeFrame: EEP (Weeks 29 to 36)
measure: Mean Time Spent in Hemoglobin Range of 10.5 - 12.5 Gram/Decilitre During the Efficacy Evaluation Period
timeFrame: EEP (Week 29 to Week 36)
measure: Number of Participants Who Required Dose Adjustments During the Dose Titration Period
timeFrame: DTP (Weeks 0 to 28)
measure: Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period
timeFrame: EEP (Weeks 29 to 36)
measure: Number of Participants Received Red Blood Cells Transfusions
timeFrame: Up to Week 28
measure: Mean Values of Hemoglobin Concentration at Baseline and Week 36
timeFrame: Baseline and Week 36
measure: Mean Values of Hematocrit at Baseline and Week 36
timeFrame: Baseline and Week 36
measure: Mean Values of Mean Corpuscular Volume at Baseline and Week 36
timeFrame: Baseline and Week 36
measure: Mean Values of Leukocytes and Platelets Count at Baseline and Week 36
timeFrame: Baseline and Week 36
measure: Mean Values of Creatinine, Potassium, Phosphate, Parathyroid Hormone , Iron and Total Iron Binding Capacity Parameters at Baseline and Week 36
timeFrame: Baseline and Week 36
measure: Mean Values of Albumin and Transferrin Concentration at Baseline and Week 36
timeFrame: Baseline and Week 36
measure: Mean Values of Ferritin Concentration at Baseline and Week 36
timeFrame: Baseline and Week 36
measure: Mean Values of Transferrin Saturation at Baseline and Week 36
timeFrame: Baseline and Week 36
measure: Mean Values of Aspartate Transaminase and Alkaline Phosphatase at Baseline and Week 36
timeFrame: Baseline and Week 36
measure: Number of Participants With Adverse Events and Serious Adverse Events
timeFrame: Up to Week 40
measure: Number of Participants With Abnormal Changes in ECG From Baseline to Week 40
timeFrame: From Baseline to Week 40
measure: Number of Participants With Abnormal Changes in Vital Signs From Baseline to Week 40
timeFrame: From Baseline to Week 40
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
city: Brasilia
country: Brazil
city: Campinas
country: Brazil
city: Campo Grande
country: Brazil
city: Cariacica
country: Brazil
city: Curitiba
country: Brazil
city: Curitiba
country: Brazil
city: Fortaleza
country: Brazil
city: Jaboatão Dos Guararapes
country: Brazil
city: Joinville
country: Brazil
city: Juiz de Fora
country: Brazil
city: Londrina
country: Brazil
city: Natal
country: Brazil
city: Porto Alegre
country: Brazil
city: Porto Alegre
country: Brazil
city: Ribeirão Preto
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Salvador
country: Brazil
city: Sao Jose Do Rio Preto
country: Brazil
city: Sao Luis
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Sorocaba
country: Brazil
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.