Trial Outcomes & Findings for A Study of Mircera (C.E.R.A.) in Patients With Pre-Dialysis Chronic Renal Anemia (NCT NCT01342640)

NCT ID: NCT01342640

Last Updated: 2017-07-12

Results Overview

Per Protocol (PP) Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin less than or equal to \[≤\] 100 nanogram per milliliter \[ng/mL\] or mean transferrin saturation \[TSAT\] ≤20% or mean hypochromic red blood cells \[RBCs\] greater than or equal to \[≥\] 10% during efficacy evaluation period \[Weeks 20 to 28\]).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 70 participants
• Primary outcome timeframe: Baseline (Week 0), Week 20
• Results posted on: 2017-07-12

Participant Flow

Participant milestones

Measure	Methoxy Polyethylene Glycol-Epoetin Beta Participants received methoxy polyethylene glycol-epoetin beta (Mircera, Continuous Erythropoietin Receptor Activator \[C.E.R.A\]) at a starting dose of 1.2 micrograms per kilogram (mcg/kg) administered via subcutaneous (SC) injection every 4 weeks for 28 weeks. Doses were adjusted according to individual's hemoglobin (Hb) level.
Overall Study STARTED	70
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	41

Reasons for withdrawal

Measure	Methoxy Polyethylene Glycol-Epoetin Beta Participants received methoxy polyethylene glycol-epoetin beta (Mircera, Continuous Erythropoietin Receptor Activator \[C.E.R.A\]) at a starting dose of 1.2 micrograms per kilogram (mcg/kg) administered via subcutaneous (SC) injection every 4 weeks for 28 weeks. Doses were adjusted according to individual's hemoglobin (Hb) level.
Overall Study Adverse Event	3
Overall Study Protocol Violation	16
Overall Study Lost to Follow-up	21
Overall Study Other	1

Baseline Characteristics

A Study of Mircera (C.E.R.A.) in Patients With Pre-Dialysis Chronic Renal Anemia

Baseline characteristics by cohort

Measure	Methoxy Polyethylene Glycol-Epoetin Beta n=70 Participants Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual's Hb level.
Age, Continuous	45.80 Years STANDARD_DEVIATION 16.68 • n=93 Participants
Sex: Female, Male Female	45 Participants n=93 Participants
Sex: Female, Male Male	25 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 20

Population: PP Population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome and n signifies those participants who were evaluable for specified time-point.

Per Protocol (PP) Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin less than or equal to [≤] 100 nanogram per milliliter [ng/mL] or mean transferrin saturation [TSAT] ≤20% or mean hypochromic red blood cells [RBCs] greater than or equal to [≥] 10% during efficacy evaluation period [Weeks 20 to 28]).

Outcome measures

Measure	Methoxy Polyethylene Glycol-Epoetin Beta n=53 Participants Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual's Hb level.
Change From Baseline in Mean Hb Concentration at Week 20 Baseline (n=53)	8.820 Grams per deciliter (gm/dL) Standard Deviation 0.736
Change From Baseline in Mean Hb Concentration at Week 20 Change at Week 20 (n=35)	1.440 Grams per deciliter (gm/dL) Standard Deviation 1.144

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 24

Population: PP Population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome.

PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period [Weeks 20 to 28]).

Outcome measures

Measure	Methoxy Polyethylene Glycol-Epoetin Beta n=32 Participants Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual's Hb level.
Change From Baseline in Mean Hb Concentration at Week 24	1.470 gm/dL Standard Deviation 1.236

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 28

Population: PP Population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome

PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period [Weeks 20 to 28]).

Outcome measures

Measure	Methoxy Polyethylene Glycol-Epoetin Beta n=28 Participants Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual's Hb level.
Change From Baseline in Mean Hb Concentration at Week 28	1.680 gm/dL Standard Deviation 1.115

Adverse Events

Methoxy Polyethylene Glycol-Epoetin Beta

Serious events: 7 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Methoxy Polyethylene Glycol-Epoetin Beta n=70 participants at risk Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual's Hb level.
Renal and urinary disorders Renal failure chronic	1.4% 1/70 • From screening up to 32 Weeks
Vascular disorders Peripheral ischemia	1.4% 1/70 • From screening up to 32 Weeks
Renal and urinary disorders Renal failure	1.4% 1/70 • From screening up to 32 Weeks
Infections and infestations Pneumonia cytomegaloviral	1.4% 1/70 • From screening up to 32 Weeks
Investigations Hemoglobin decreased	1.4% 1/70 • From screening up to 32 Weeks
Injury, poisoning and procedural complications Complications of transplanted kidney	1.4% 1/70 • From screening up to 32 Weeks
Metabolism and nutrition disorders Hypocalcemia	1.4% 1/70 • From screening up to 32 Weeks
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.4% 1/70 • From screening up to 32 Weeks

Other adverse events

Measure	Methoxy Polyethylene Glycol-Epoetin Beta n=70 participants at risk Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual's Hb level.
Infections and infestations Urinary tract infection	10.0% 7/70 • From screening up to 32 Weeks

Additional Information

Medical Communications

Hoffmann-LaRoche

Phone: 800-821-8590

Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER