Clinical trial NCT00661505: A Study of Intravenous Mircera in Hemodialysis 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 C.E.R.A. for the Maintenance of Haemoglobin Levels in Haemodialysis Patients With Chronic Renal Anaemia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-04-18
Enrollment: 132
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 intravenous Mircera for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Patients will receive 4-weekly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms. 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 stable iv or sc maintenance epoetin therapy during previous 4 weeks;
* regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.

Exclusion Criteria:

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

Primary outcomes:
measure: Percentage of Participants Who Maintained Their Mean Hemoglobin Concentration Within +/- 1.0 Gram/Deciliter of Their Reference Hemoglobin Concentration and Between 10.0 and 12.0 Gram/Deciliter During the Efficacy Evaluation Period
timeFrame: EEP (Week 16 to Week 24)
Secondary outcomes:
measure: Mean Change in Hemoglobin Concentration Between the Stability Verification Period and the Efficacy Evaluation Period
timeFrame: SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24)
measure: Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period
timeFrame: EEP (Week 16 to Week 24)
measure: Median Time Spent in the Hemoglobin Range 10.0-12.0 Gram/Deciliter During the Efficacy Evaluation Period
timeFrame: EEP (Week 16 to Week 24)
measure: Mean C.E.R.A. Dose Required to Maintain Hemoglobin Level Within the Range 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period
timeFrame: EEP (Week 16 to Week 20)
measure: Percentage of Participants Requiring Any Dose Adjustments in C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period
timeFrame: DTP (Week 1 to Week 16), EEP (Week 16 to Week 24)
measure: Mean Monthly Dose of C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period
timeFrame: DTP (Week 1 to Week 16), EEP (Week 16 to Week 24)
measure: Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume at Week 16 and Week 24
timeFrame: BL (Week -4 to Week 0), Week 16, and Week 24
measure: Mean Change From Baseline in Hematocrit at Week 16 and Week 24
timeFrame: BL (Week -4 to Week 0), Week 16, and Week 24
measure: Mean Change From Baseline in Hemoglobin at Week 16 and Week 24
timeFrame: BL (Week -4 to Week 0), Week 16, and Week 24
measure: Mean Change From Baseline in Leucocytes and Platelet at Week 16 and Week 24
timeFrame: BL (Week -4 to Week 0), Week 16, and Week 24
measure: Mean Change From Baseline in Ferritin at Week 16 and Week 24
timeFrame: BL (Week -4 to Week 0), Week 16, and Week 24
measure: Mean Change From Baseline in Iron, Total Iron Binding Capacity, and Creatinine at Week 16 and Week 24
timeFrame: BL (Week -4 to Week 0), Week 16, and Week 24
measure: Mean Change From Baseline in Transferrin and Albumin at Week 16 and Week 24
timeFrame: BL (Week -4 to Week 0), Week 16, and Week 24
measure: Mean Change From Baseline in Transferrin Saturation at Week 16 and Week 24
timeFrame: BL (Week -4 to Week 0), Week 16, and Week 24
measure: Mean Change From Baseline in C-Reactive Protein at Week 16 and Week 24
timeFrame: BL (Week -4 to Week 0), Week 16, and Week 24
measure: Mean Change From Baseline in Phosphate and Potassium at Week 16 and Week 24
timeFrame: BL (Week -4 to Week 0), Week 16, and Week 24
measure: Mean Change From Baseline in Weight at Week 16 and Week 24
timeFrame: BL (Week -4 to Week 0), Week 16, and Week 24
measure: Mean Change in From Baseline in Blood Pressure at Week 16 and Week 24
timeFrame: Baseline (Week -4 to Week 0), Week 16, and Week 24
measure: Number of Participants Taking Concomitant Medications
timeFrame: Up to Week 28
measure: Number of Participants With Any Adverse Events and Serious Adverse Events
timeFrame: Up to Week 28
measure: Number of Participants With Reports of Anti-erythropoietin Antibodies
timeFrame: Up to Week 24
measure: Number of Participants Who Received Red Blood Cell Transfusions During the Dose Titration Period and Efficacy Evaluation Period
timeFrame: Week 1 to Week 24
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University Medical Faculty; Internal Medicine
city: Ankara
country: Turkey
facility: Ankara Research and Training Hospital; The Clinic of Nephrology
city: Ankara
country: Turkey
facility: Ankara University School of Medicine; Nephrology
city: Ankara
country: Turkey
facility: Faith University School of Medicine; Nephrology
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty; Department of Internal Medicine
city: Ankara
country: Turkey
facility: Baskent University Hospital; Transplantation
city: Ankara
country: Turkey
facility: Gazi University School of Medicine; Nephrology
city: Aydin
country: Turkey
facility: Adnan Menderes Uni School of Medicine; Physical Therapy & Rehabilitation
city: Diyarbakir
country: Turkey
facility: Dicle Uni Medical Faculty; Internal Medicine
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty; Internal Medicine; Nephrology
city: Elazig
country: Turkey
facility: Firat Uni School Of Medicine; Nephrology
city: Erzurum
country: Turkey
facility: Ataturk University Medical Faculty; Department of Internal Medicine
city: Istanbul
country: Turkey
facility: Sisli Etfal Research and Training Hospital; The Clinic of Nephrology
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Medical Faculty; Department of Internal Medicine
city: Istanbul
country: Turkey
facility: Marmara Uni School of Medicine; Nephrology
city: Izmir
country: Turkey
facility: Izmir Ataturk Research and Training Hospital; The Clinic of Nephrology
city: Izmir
country: Turkey
facility: Dokuz Eylul University School of Medicine; Nephrology
city: Kayseri
country: Turkey
facility: Erciyes University School of Medicine; Nephrology
city: Malatya
country: Turkey
facility: Inonu Uni School of Medicine
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty
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.