Anemia, Chronic Kidney Disease
Conditions
Keywords
Quality of Life, Chronic Kidney Disease, Anemia
Brief summary
Treatment of anemia associated with chronic kidney disease (CKD) during 36 weeks with safety follow up phase of 52 weeks
Detailed description
This is a multicentre, randomised, single-blind, placebo-controlled, two-arm parallel group study assessing the effect of anaemia correction and Hb maintenance with darbepoetin alfa in elderly CKD patients for 36 weeks.
Interventions
DRUGDarbepoetin alfa
Starting dose was calculated at 0.75 micrograms per kilogram (μg/kg) body weight at randomization, rounded to nearest prefilled syringe dose unit. Dose was titrated incrementally. Monthly dose was initially double the every 2 week dose at time of conversion.
DRUGPlacebo
Prefilled syringe placebo, to match active arm
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Stage 3-5 CKD not on dialysis * Patients ≥ 70 years of age * Haemoglobin \< 110g/L at screening * Transferrin saturation ≥ 15% at screening
Exclusion criteria
* Clinical history of type 2 diabetes mellitus * Anticipating or scheduled to go on renal replacement therapy in the next year, including renal transplant * Uncontrolled hypertension on two separate measurements during screening * Use of any erythropoietic protein within 12 weeks of screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Form 36 Health Survey Questionnaire (SF-36) Vitality Subscale Score at Week 24 | Week 24 | The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hemoglobin (Hb) ≥ 110 g/L | Evaluation Period (Weeks 22-36) | Number of participants achieving a Hemoglobin (Hb) value ≥ 110 g/L during the evaluation period. |
| Mean Hemoglobin During the Evaluation Period | Evaluation Period (Weeks 22-36) | — |
| Euroqol 5 Dimension (EQ-5D) Utility Score at Week 24 | Week 24 | The EQ-5D is a patient-completed, multidimensional measure of health related quality of life. The instrument is applicable to a wide range of health conditions and treatments and results in a single index score. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension comprises three levels (no problems, some/moderate problems, extreme problems). A unique EQ-5D health state is defined by combining one level from each of the five dimensions. EQ-5D index values range from -0.59 to 1.00. Higher EQ-5D Index scores represent better health status. |
Participant flow
Recruitment details
Participants were enrolled from 21 September 2006 through 6 November 2007
Participants by arm
| Arm | Count |
|---|---|
| Darbepoetin Alfa Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months. | 28 |
| Placebo Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months. | 23 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Physician Decision | 8 | 8 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Darbepoetin Alfa | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 79.2 Years STANDARD_DEVIATION 4.9 | 81.0 Years STANDARD_DEVIATION 5.1 | 80.0 Years STANDARD_DEVIATION 5 |
| Race/Ethnicity, Customized Asian | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White or Caucasian | 26 Participants | 22 Participants | 48 Participants |
| Sex: Female, Male Female | 13 Participants | 9 Participants | 22 Participants |
| Sex: Female, Male Male | 15 Participants | 14 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 21 / 28 | 18 / 23 |
| serious Total, serious adverse events | 7 / 28 | 5 / 23 |
Outcome results
Primary
Short Form 36 Health Survey Questionnaire (SF-36) Vitality Subscale Score at Week 24
The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).
Time frame: Week 24
Population: Subset of Full Analysis Set, composed of all randomized participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Darbepoetin Alfa | Short Form 36 Health Survey Questionnaire (SF-36) Vitality Subscale Score at Week 24 | 51.4 Units on a scale | Standard Error 1.6 |
| Placebo | Short Form 36 Health Survey Questionnaire (SF-36) Vitality Subscale Score at Week 24 | 46.7 Units on a scale | Standard Error 2.8 |
Secondary
Euroqol 5 Dimension (EQ-5D) Utility Score at Week 24
The EQ-5D is a patient-completed, multidimensional measure of health related quality of life. The instrument is applicable to a wide range of health conditions and treatments and results in a single index score. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension comprises three levels (no problems, some/moderate problems, extreme problems). A unique EQ-5D health state is defined by combining one level from each of the five dimensions. EQ-5D index values range from -0.59 to 1.00. Higher EQ-5D Index scores represent better health status.
Time frame: Week 24
Population: Subset of Full Analysis Set, composed of all randomized participants with available data
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Darbepoetin Alfa | Euroqol 5 Dimension (EQ-5D) Utility Score at Week 24 | 0.763 Units on a scale |
| Placebo | Euroqol 5 Dimension (EQ-5D) Utility Score at Week 24 | 0.712 Units on a scale |
Secondary
Mean Hemoglobin During the Evaluation Period
Time frame: Evaluation Period (Weeks 22-36)
Population: Subset of Full Analysis Set, composed of all randomized participants with available data
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Darbepoetin Alfa | Mean Hemoglobin During the Evaluation Period | 125.85 g/L |
| Placebo | Mean Hemoglobin During the Evaluation Period | 104.50 g/L |
Secondary
Number of Participants With Hemoglobin (Hb) ≥ 110 g/L
Number of participants achieving a Hemoglobin (Hb) value ≥ 110 g/L during the evaluation period.
Time frame: Evaluation Period (Weeks 22-36)
Population: Subset of Full Analysis Set, composed of all randomized participants with available data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Darbepoetin Alfa | Number of Participants With Hemoglobin (Hb) ≥ 110 g/L | 19 Participants |
| Placebo | Number of Participants With Hemoglobin (Hb) ≥ 110 g/L | 7 Participants |
95% CI: [0.173, 0.643]
95% CI: [0.751, 0.999]