Clinical trial NCT00517413: LATINO Study: A Study of Mircera for the Maintenance Treatment of 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 Intravenous and/or Subcutaneous C.E.R.A for the Maintenance of Hemoglobin 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: 2007-08-17
Enrollment: 163
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 and safety of Mircera when administered once monthly, subcutaneously or intravenously, for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with epoetin alfa will receive 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. 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;
* hemodialysis or peritoneal dialysis, with same mode of dialysis for \>=3 months before and throughout screening period;
* stable maintenance epoetin alfa therapy for past 2 months.

Exclusion Criteria:

* transfusion of red blood cells during previous 2 months;
* poorly controlled hypertension requiring interruption of epoetin alfa in past 6 months;
* acute or chronic bleeding during previous 2 months.

Primary outcomes:
measure: Percentage of Participants Maintaining Their Mean Hb Concentration Within ±1.0 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter
timeFrame: EEP (Week 16 to 24)
Secondary outcomes:
measure: Mean Change in the Hb Concentration Between the Stability Verification Period and the EEP
timeFrame: SVP (Week -4 to -1), EEP (Week 16 to 24)
measure: Percentage of Participants Maintaining Hb Concentration Within The Target Range 10.5 and 12.5 g/dL Throughout the EEP
timeFrame: EEP (Week 16 to 24)
measure: Mean Time Spent by the Participants in the Hb Target Range 10.5-12.5 g/dL During EEP
timeFrame: EEP (Week 16 to 24)
measure: Mean C.E.R.A Dose To Maintain Hb Level Within the Range 10.5-12.5 g/dL Throughout the EEP
timeFrame: EEP (Week 16 to 24)
measure: Percentage of Participants Requiring Dose Adjustments of C.E.R.A During the DTP and EEP
timeFrame: Baseline (Week 0) to Week 24
measure: Mean Monthly Dose of C.E.R.A During the DTP and EEP
timeFrame: Baseline (Week 0) to Week 24
measure: Incidence of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase
timeFrame: Baseline (Week 0) to Week 44
measure: Number of Participants With Adverse Events and Serious Adverse Events
timeFrame: Up to Week 52
measure: Mean Haemoglobin Levels Over Time
timeFrame: Baseline (Week 0), Week 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
measure: Mean Hematocrit Levels Over Time
timeFrame: Baseline (Week 0), Week 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
measure: Mean White Blood Cells and Thrombocyte Levels Over Time
timeFrame: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48
measure: Mean Phosphate and Potassium Levels Over Time
timeFrame: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48
measure: Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
timeFrame: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48
measure: Mean Transferrin Saturation Levels Over Time
timeFrame: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48
measure: Mean Albumin and Transferrin Levels Over Time
timeFrame: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48
measure: Mean C-Reactive Protein Levels Over Time
timeFrame: Baseline (Week 0), 8, 16, 24, 32, 40, and 48
measure: Mean Ferritin Levels Over Time
timeFrame: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Córdoba
country: Argentina
city: Santa Fe
country: Argentina
city: Aracajú
country: Brazil
city: Curitiba
country: Brazil
city: Fortaleza
country: Brazil
city: Sao Paulo
country: Brazil
city: Santiago
country: Chile
city: Bogota
country: Colombia
city: Bogotá
country: Colombia
city: Quito
country: Ecuador
city: Cuernavaca
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Monterrey
country: Mexico
city: Callao
country: Peru
city: Callao
country: Peru
city: Lima
country: Peru
city: Montevideo
country: Uruguay
city: Montevideo
country: Uruguay
city: Caracas
country: Venezuela
city: Caracas
country: Venezuela
city: Maracaibo
country: Venezuela
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.