Clinical trial NCT00576303: A Study of Intravenous Mircera in Dialysis Patients With Chronic Renal Disease and Anemia.
Official title: A Single-arm, Open Label Multicenter Study to Assess the Efficacy, Safety and Tolerability of Once Monthly Administration of 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: 2007-12-19
Enrollment: 200
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 monthly intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal disease, currently receiving epoetin alfa or beta. Patients will receive monthly intravenous injections of Mircera at a starting dose of 120, 200 or 360 micrograms/month, depending on the dose of epoetin alfa or beta 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;
* continuous maintenance epoetin alfa or beta therapy with the same dosing interval during the previous 2 months.

Exclusion Criteria:

* transfusion of red blood cells during previous 2 months;
* poorly controlled hypertension requiring interruption of epoetin alfa or beta treatment in past 6 months;
* significant acute or chronic bleeding such as overt gastrointestinal bleeding;
* hemolysis;
* folic acid and vitamin B12 deficiency.

Primary outcomes:
measure: Percentage of Participants Maintaining Average Hemoglobin Concentration Within +\- 1 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter During EEP
timeFrame: EEP (Week 16 to Week 24)
Secondary outcomes:
measure: Mean Change in Hb Concentration From Baseline to the EEP
timeFrame: Baseline (Week -4 to Week -1), EEP (Week 16 to Week 24)
measure: Percentage of Participants Maintaining Average Hb Concentration Within Target Range of 10.5-12.5 g/dL Throughout the EEP
timeFrame: EEP (Week 16 to Week 24)
measure: Mean Number of Days Spent Within Hb Range of 10.5-12.5 g/dL During the EEP
timeFrame: EEP (Week 16 to Week 24)
measure: Number of Participants Requiring Any Dose Adjustment During the DTP, EEP, and LTSP
timeFrame: DTP (Week 1 to Week 16), EEP (Week 16 to Week 24) and LTSP (Week 24 to Week 44)
measure: Number of Participants With Red Blood Cell Transfusion
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Ekaterinburg
country: Russian Federation
city: Kemerovo
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Omsk
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St-Petersburg
country: Russian Federation
city: Volzhsky
country: Russian Federation
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.