A Study of Subcutaneous C.E.R.A. for the Treatment of Anemia in Pre-Dialysis Patients.

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

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.

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Drug: methoxy polyethylene glycol-epoetin beta [C.E.R.A.]

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Ekaterinburg, Russian Federation, 620102
  • Irkutsk, Russian Federation, 664079
  • Khanty-Mansiysk, Russian Federation, 628011
  • Moscow, Russian Federation, 123182
  • Moscow, Russian Federation, 125101
  • Moscow, Russian Federation, 129110
  • Moscow, Russian Federation, 117036
  • Nizhny Novgorod, Russian Federation, 603126
  • Nizhny Novgorod, Russian Federation, 603001
  • Omsk, Russian Federation, 644112
  • Orenburg, Russian Federation, 460018
  • Rostov-na-donu, Russian Federation, 344029
  • Saratov, Russian Federation, 410053
  • St Petersburg, Russian Federation, 195067
  • St Petersburg, Russian Federation, 197089
  • St Petersburg, Russian Federation, 197110
  • St Petersburg, Russian Federation, 194354
  • Tjumen, Russian Federation, 625023
  • UFA, Russian Federation, 450005

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: C.E.R.A; Participants received methoxy polyethylene glycol-epoetin beta (Continuous Erythropoietin Receptor Activator [C.E.R.A]) subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 microgram per kilogram (mcg/kg) of C.E.R.A. Once the Hemoglobin (Hb) concentration was attained within the target range of 11.0 and 13.0 gram per deciliter (g/dL), the dose was adjusted to maintain the Hb concentration within the target range.

Drug: methoxy polyethylene glycol-epoetin beta [C.E.R.A.]; Recommended starting dose 1.2 micrograms/kg sc monthly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period	The mean change in Hb concentration between Baseline and Efficacy Evaluation Period (EEP) was calculated by subtracting the baseline Hb concentration from the EEP Hb concentration. Each participant included in this analysis had at least 3 recorded Hb values during EEP, and these Hb values were combined using a time-adjusted average. The EEP was from Week 29 to Week 36.	Baseline (Week 0) and from Week 29 to Week 36

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Maintaining Average Hb Concentration Within the Target Range of 11.0-13.0 g/dL Throughout the EEP	Percentage of participants maintaining individual Hb concentration within the range of 11.0-13.0 g/dL was reported during EEP. The EEP was from Week 29 to Week 36.	From Week 29 to Week 36
Mean Time Spent in Target Hb Range of 11.0 -13.0 g/dL During the Efficacy Evaluation Period	The number of days spent by participants with Hb in range of 11.30 -13.0 g/dL was calculated during the EEP and presented. The EEP comprised was from Week 29 to Week 36.	From Week 29 to Week 36
The Number of Participants Who Required Dose Adjustments During the Dose Titration Period	The number of participants who required dose adjustments of C.E.R.A was reported during the Dose Titration Period (DTP). The DTP was from Week 0 to Week 28.	From Week 0 to Week 28 (DTP)
Time to Achievement of Response During the Efficacy Evaluation Period	The time to achievement of response was defined as the time when the participants achieved Hb concentration within the target range of 11.0 to 13.0 g/dL during the EEP. The EEP was from Week 29 to Week 36.	From Week 29 to Week 36
Number of Participants With Red Blood Cells Transfusions.	The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study was reported.	Up to Week 52
Mean Values of Laboratory Parameter : Hb Concentration	The mean Hb concentration for each individual participant throughout the study was estimated. Summary data of mean values of Hb concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.	Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
Mean Values of Laboratory Parameter : Hematocrit	Hematocrit is a blood test that measures the percentage of the volume of whole blood that is made up of red blood cells (RBC). This measurement depends on the number of red blood cells and the size of red blood cells. The mean values of hematocrit for each individual participant were estimated throughout the study. Summary data of mean values of hematocrit at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.	Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration	The mean values of potassium and phosphate levels in serum for each individual participant were estimated throughout the study. Summary data of mean values of potassium and phosphate level in serum at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.	Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity	The mean values of iron and total iron binding capacity (TIBC) for each individual participant were estimated throughout the study. Summary data of mean values of iron and TIBC at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.	Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
Mean Values of Laboratory Parameter : Serum Creatinine	The mean values of serum creatinine for each individual participant throughout the study were estimated. Summary data of mean values of serum creatinine at Week 0 (Baseline) and Week 32 are presented.	Baseline (Week 0), and Week 32
Mean Values of Laboratory Parameter: C Reactive Protein	The mean values of C reactive protein (CRP) for each individual participant throughout the study were estimated. Summary data of mean values of CRP at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.	Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration	The mean values of albumin and transferrin concentration for each individual participant throughout the study were estimated. Summary data of mean values of albumin and transferrin concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.	Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
Mean Values of Laboratory Parameter: Ferritin Concentration	The mean values of ferritin concentration for each individual participant throughout the study were estimated. Summary data of mean values of ferritin concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.	Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count	The mean values of white blood cell (WBC) and thrombocyte count for each individual participant were estimated throughout the study. Summary data of mean values of WBC and thrombocyte count at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.	Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
Mean Values of Laboratory Parameters: Transferrin Saturation	The mean values for transferrin saturation (TSAT) for each individual participant were estimated throughout the study. Summary data of mean values of TSAT at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.	Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
The Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period	The number of participants who required dose adjustments of C.E.R.A was reported during the EEP. EEP was from Week 29 to Week 36.	From Week 29 to Week 36 (EEP)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: December 18, 2007
• First Submitted That Met QC Criteria: December 18, 2007
• First Posted (Estimate): December 19, 2007

Study Record Updates

• Last Update Posted (Estimate): November 30, 2016
• Last Update Submitted That Met QC Criteria: October 7, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: ML20978