Anemia
Conditions
Brief summary
This single arm, open label, multicenter study will evaluate the safety and change in hemoglobin levels of Mircera (C.E.R.A.; methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia who are not on dialysis. Patients will receive as a recommended starting dose 1.2 micrograms of Mircera subcutaneously every 4 weeks. The starting dose is dependent on the patient's weight. Dose adjustment may be required due to inadequate or excessive treatment response. The anticipated time on study treatment is 28 weeks.
Interventions
DRUGmethoxy polyethylene glycol-epoetin beta [Mircera]
Recommended starting dose 1.2 micrograms/kg subcutaneously every 4 weeks (depending on patient's weight). Dose adjustment may be required in the event of inadequate or excessive treatment response.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, age \>/=18 years * Diagnosis of chronic renal anemia * Not on dialysis * Hemoglobin concentration \<10 g/dl * No erythropoiesis stimulating agent (ESA) therapy during the 3 months before study start * Estimated glomerular filtration rate (EGFR) \<60 ml/min and \>/=20 ml/min * Adequate iron status
Exclusion criteria
* Transfusion of red blood cells during the previous 2 months * Poorly controlled hypertension * Significant acute or chronic bleeding, e.g. gastrointestinal bleeding * Active malignant disease (except non-melanoma skin cancer) * Hemolysis * Hemoglobinopathies, e.g. sickle-cell disease, thalassemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Hb Concentration at Week 20 | Baseline (Week 0), Week 20 | 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 \[Weeks 20 to 28\]). |
| Change From Baseline in Mean Hb Concentration at Week 24 | Baseline (Week 0), Week 24 | 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 \[Weeks 20 to 28\]). |
| Change From Baseline in Mean Hb Concentration at Week 28 | Baseline (Week 0), Week 28 | 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 \[Weeks 20 to 28\]). |
Countries
Egypt
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Methoxy Polyethylene Glycol-Epoetin Beta 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. | 70 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lost to Follow-up | 21 |
| Overall Study | Other | 1 |
| Overall Study | Protocol Violation | 16 |
Baseline characteristics
| Characteristic | Methoxy Polyethylene Glycol-Epoetin Beta |
|---|---|
| Age, Continuous | 45.80 Years STANDARD_DEVIATION 16.68 |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 70 |
| serious Total, serious adverse events | 7 / 70 |
Outcome results
Primary
Change From Baseline in Mean Hb Concentration at Week 20
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 \[Weeks 20 to 28\]).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methoxy Polyethylene Glycol-Epoetin Beta | Change From Baseline in Mean Hb Concentration at Week 20 | Baseline (n=53) | 8.820 Grams per deciliter (gm/dL) | Standard Deviation 0.736 |
| Methoxy Polyethylene Glycol-Epoetin Beta | 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 |
Comparison: Change from baseline in mean Hb levels at Week 20 was analyzed using paired t-test.p-value: <0.0001Paired t-test
Primary
Change From Baseline in Mean Hb Concentration at Week 24
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 \[Weeks 20 to 28\]).
Time frame: Baseline (Week 0), Week 24
Population: PP Population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methoxy Polyethylene Glycol-Epoetin Beta | Change From Baseline in Mean Hb Concentration at Week 24 | 1.470 gm/dL | Standard Deviation 1.236 |
Comparison: Change from baseline in mean Hb levels at Week 24 was analyzed using paired t-test.p-value: <0.0001Paired t-test
Primary
Change From Baseline in Mean Hb Concentration at Week 28
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 \[Weeks 20 to 28\]).
Time frame: Baseline (Week 0), Week 28
Population: PP Population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methoxy Polyethylene Glycol-Epoetin Beta | Change From Baseline in Mean Hb Concentration at Week 28 | 1.680 gm/dL | Standard Deviation 1.115 |
Comparison: Change from baseline in mean Hb levels at Week 28 was analyzed using paired t-test.p-value: <0.0001Paired t-test