Clinical trial NCT00576628: A Study of Subcutaneous C.E.R.A. for the Treatment of Anemia in Pre-Dialysis Patients.
Official title: A Single Arm Open Label Multicentre Study to Assess the Efficacy, Safety and Tolerability of Monthly Administration of Subcutaneous C.E.R.A. for the Treatment of Chronic Renal Anaemia in Pre-dialysis Patients, Not Currently Treated With ESA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-12-19
Enrollment: 133
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 subcutaneous C.E.R.A. for correction of anemia and maintenance of hemoglobin levels in patients with chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible patients will receive C.E.R.A. by monthly subcutaneous injections, dependent on body weight (with a recommended starting dose of 1.2 micrograms/kg). 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, with no need for dialysis expected in next 3 months;
* adequate iron status.

Exclusion Criteria:

* previous epoetin therapy within 12 weeks prior to treatment;
* transfusion of red blood cells during 2 months prior to screening;
* significant acute or chronic bleeding such as overt gastrointestinal bleeding;
* hemolysis;
* folic acid and vitamin B 12 deficiency.

Primary outcomes:
measure: Mean Change in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period
timeFrame: Baseline (Week 0) and from Week 29 to Week 36
Secondary outcomes:
measure: Percentage of Participants Maintaining Average Hb Concentration Within the Target Range of 11.0-13.0 g/dL Throughout the EEP
timeFrame: From Week 29 to Week 36
measure: Mean Time Spent in Target Hb Range of 11.0 -13.0 g/dL During the Efficacy Evaluation Period
timeFrame: From Week 29 to Week 36
measure: The Number of Participants Who Required Dose Adjustments During the Dose Titration Period
timeFrame: From Week 0 to Week 28 (DTP)
measure: Time to Achievement of Response During the Efficacy Evaluation Period
timeFrame: From Week 29 to Week 36
measure: Number of Participants With Red Blood Cells Transfusions.
timeFrame: Up to Week 52
measure: Mean Values of Laboratory Parameter : Hb Concentration
timeFrame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
measure: Mean Values of Laboratory Parameter : Hematocrit
timeFrame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
measure: Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration
timeFrame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
measure: Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity
timeFrame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
measure: Mean Values of Laboratory Parameter : Serum Creatinine
timeFrame: Baseline (Week 0), and Week 32
measure: Mean Values of Laboratory Parameter: C Reactive Protein
timeFrame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
measure: Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration
timeFrame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
measure: Mean Values of Laboratory Parameter: Ferritin Concentration
timeFrame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
measure: Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count
timeFrame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
measure: Mean Values of Laboratory Parameters: Transferrin Saturation
timeFrame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
measure: The Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period
timeFrame: From Week 29 to Week 36 (EEP)
Other outcomes:
Locations:
city: Ekaterinburg
country: Russian Federation
city: Irkutsk
country: Russian Federation
city: Khanty-Mansiysk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Omsk
country: Russian Federation
city: Orenburg
country: Russian Federation
city: Rostov-na-donu
country: Russian Federation
city: Saratov
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: Tjumen
country: Russian Federation
city: UFA
country: Russian Federation
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: