TerminatedPhase 3

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

Stopped: The study was terminated due to the slow recruitment rate.

Sweden29 participantsStarted 2007-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

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

Timeframe: Week 17 up to Week 24

Trial details

NCT IDNCT00517881

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-11

Results submitted2016-04-21