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

Phase 3

Terminated

• Conditions: Anemia
• Interventions: Drug: Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)

• Registration Number: NCT00517881
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-08-16
• Study First Submitted QC: 2007-08-16
• Study First Posted: 2007-08-17
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2016-04
• Results First Submitted: 2016-04-21
• Results First Submitted QC: 2016-04-21
• Last Update Submitted: 2016-04-21
• Results First Posted: 2016-05-27
• Last Update Posted: 2016-05-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
C.E.R.A.	Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)	-

Primary Outcome Measures

Name	Time	Method
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	Week 17 up to Week 24	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.

Secondary Outcome Measures

Name	Time	Method
Change in Hemoglobin Concentration Between Reference (SVP) and EEP	Week 17 up to Week 24	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.
Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP	Week 17 up to Week 24	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.
Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP	Week 17 up to Week 24	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.
Percentage of Participants Requiring Any Dose Adjustment	Week 1 up to Week 16 and Week 17 up to Week 24	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.
Percentage of Participants With Red Blood Cell Transfusion During the Study	Week 0 up to Week 24	Percentage of participant who required red blood cell transfusion during the study was reported.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Week 0 up to Week 24	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.