Efficacy, Safety and Tolerability Study of Subcutaneous C.E.R.A. in Pre-Dialysis Participants With Chronic Renal Anemia

A Single Arm Open Label Study to Assess the Efficacy, Safety and Tolerability of Once Monthly Administration of Subcutaneous C.E.R.A. for the Maintenance of Haemoglobin Levels in Pre-dialysis Patients With Chronic Renal Anaemia

This single arm study will assess the efficacy, safety and tolerability of subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) for maintenance of hemoglobin levels in pre-dialysis participants with chronic renal anemia. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa will receive monthly subcutaneous injections of C.E.R.A. with the starting dose of 120, 200 or 360 micrograms (mcg) derived from the dose of darbepoetin alfa or epoetin alfa in the week preceding study start.

Study Overview

• Status: Terminated
• Conditions: Anemia
• Intervention / Treatment: Drug: Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 3

Contacts and Locations

Study Locations

• Sweden
  • Danderyd, Sweden, 18288
  • Eksjo, Sweden, 57581
  • Eskilstuna, Sweden, 63188
  • Gaevle, Sweden, 80187
  • Goeteborg, Sweden, 41345
  • Gothenburg, Sweden, S-402 76
  • Huddinge, Sweden, 14186
  • Jonkoping, Sweden, 55185
  • Kristianstad, Sweden, 29185
  • Skellefteå, Sweden, S-931 86
  • Stockholm, Sweden, 17176
  • Umea, Sweden, 90185
  • Värnamo, Sweden, 33185
  • Västervik, Sweden, 59381

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:

• Chronic renal anemia
• Hemoglobin concentration between 10.5 gram per deciliter (g/dL) and 12.5 g/dL
• Adequate iron status (serum ferritin greater than [>] 100 nanogram per milliliter and Transferrin Saturation >20 percent [%] or hypochromic red cells less than [<] 10%)
• Continuous subcutaneous maintenance darbepoetin alfa therapy with same dosing interval during previous 2 months

Exclusion Criteria:

• Transfusion of red blood cells during previous 2 months
• Poorly controlled hypertension requiring hospitalization or interruption of darbepoetin alfa treatment in previous 6 months
• Acute or chronic bleeding
• Active malignant disease (except non-melanoma skin cancer)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: C.E.R.A.	Drug: Methoxy polyethylene glycol-epoetin beta (C.E.R.A.); Subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments will be performed during the study depending on the participant's blood hemoglobin levels.; Other Names: Mircera

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Their Reference Hemoglobin and Within the Target Range	Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.5 to 12.5 g/dL during the efficacy evaluation period (EEP) was reported. The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the stability verification period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 to Week 24) was estimated as a time adjusted average.	Week 17 up to Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hemoglobin Concentration Between Reference (SVP) and EEP	The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the SVP at Weeks -4, -3, -2, -1 and 0. The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week 0) and the value during EEP (Week 17 up to Week 24) was assessed.	Week 17 up to Week 24
Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP	Percentage of participants maintaining hemoglobin concentration within the target range of 10.5 to 12.5 g/dL during EEP (Week 17 to Week 24) was reported.	Week 17 up to Week 24
Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP	Mean time spent by participants with hemoglobin concentration within the target range of 10.5 to 12.5 g/dL during the EEP (Week 17 to Week 24) was reported.	Week 17 up to Week 24
Percentage of Participants Requiring Any Dose Adjustment	Percentage of participants requiring any adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.	Week 1 up to Week 16 and Week 17 up to Week 24
Percentage of Participants With Red Blood Cell Transfusion During the Study	Percentage of participant who required red blood cell transfusion during the study was reported.	Week 0 up to Week 24
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious as well as non-serious AEs.	Week 0 up to Week 24

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (ACTUAL): November 1, 2009
• Study Completion (ACTUAL): November 1, 2009

Study Registration Dates

• First Submitted: August 16, 2007
• First Submitted That Met QC Criteria: August 16, 2007
• First Posted (ESTIMATE): August 17, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): May 27, 2016
• Last Update Submitted That Met QC Criteria: April 21, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: ML20944; 2006-006523-40 (EUDRACT_NUMBER)