Anemia, Secondary Hyperparathyroidism
Conditions
Keywords
Anemia, Intact Parathyroid Hormone (iPTH), Secondary Hyperparathyroidism (SHPT)
Brief summary
The purpose of this study is to show that the use of cinacalcet in patients with End Stage Renal Disease can help achieve NKF K/DOQI targets for both serum calcium and calcium phosphorous product.
Interventions
DRUGCinacalcet
Cinacalcet tablets
Sponsors
Amgen
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
* Patients with ESRD requiring maintenance dialysis (haemodialysis, haemodiafiltration, haemofiltration, or peritoneal dialysis) for at least 1 month * Being treated with Aranesp for anaemia management and have stabilised haemoglobin (Hb) levels. Hb stabilisation is defined as two consecutive Hb measurements during the screening period (that must include the most recent assessment) above 110 g/L. * Males or females \> 18 years of age at the time of informed consent * Patients participating in this study must agree to use, in the opinion of the principal investigator, highly effective contraceptive measures throughout the study. Females must have a negative serum pregnancy test within 21 days before day 1 if they are of child-bearing potential * The mean of 2 Intact parathyroid hormone (iPTH) determinations within 21 days before study day 1 and drawn at least 2 days apart must be \> 31.8 pmol/L (300 pg/mL) and \< 84.8 pmol/L (800 pg/mL) * The mean of 2 serum calcium determinations (corrected for albumin) drawn on the same day as the PTH determinations must be \> 2.1 mmol/L (8.4 mg/dL) * Signed the Independent Ethics Committee (IEC) approved Informed Consent document, before ANY study specific procedures are initiated
Exclusion criteria
* Have received vitamin D therapy for less than 21 days before day 1 or required a change in prescribed vitamin D brand or dose within 21 days before day 1. If patients are not prescribed vitamin D therapy, they must remain free of vitamin D therapy for the 21 days before day 1 * Have an unstable medical condition, defined as having been hospitalised, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator * Hypersensitivity to Sensipar or any of its components * Are currently breastfeeding * Have had a parathyroidectomy in the 3 months before day 1 * Experienced a myocardial infarction within 3 months prior to day 1 * Have had a red blood cell transfusion within 3 months prior to day 1 * Are currently enrolled in, or have not yet completed at least 30 days before day 1 other invasive investigational device or investigational drug trials, or are receiving other investigational agents (experimental dialysis machines are acceptable) * Have a gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets * Have a disorder that would interfere with understanding and giving informed consent, or compliance with protocol requirements * Have previously enrolled in this study or participated in other trials of Sensipar
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Mean Intact Parathyroid Hormone Value Between 150 and 300 pg/mL and a Calcium - Phosphorus Product Value < 55 mg^2/dL^2 | Weeks 17 to 23 | The National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF K/DOQI) recommends that treatment interventions to control parathyroid hormone should not result in significant elevation of calcium - phosphorus product (Ca x P; a derived value calculated from serum calcium and phosphorus levels). The primary objective of the study was to assess the simultaneous achievement of NKF K/DOQI targets of intact parathyroid hormone (iPTH) greater than or equal to 15.9 pmol/L and less than or equal to 31.8 pmol/L (150 - 300 pg/mL) and a Ca x P value \< 4.44 mmol\^2/L\^2 (55 mg\^2/dL\^2) during the effectiveness assessment phase. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved a Mean iPTH Value Between 150 and 300 pg/mL | Weeks 17 to 23 | Number of participants who achieved a mean intact Parathyroid Hormone (iPTH) value greater than or equal to 15.9 and less than or equal to 31.8 pmol/L (150 - 300 pg/mL) during the effectiveness assessment phase. |
| Number of Participants Who Achieved a Mean Ca x P Value < 4.44 mmol^2/L^2 (55 mg^2/dL^2) | Weeks 17 to 23 | The number of participants who achieved a mean serum calcium x phosphorus (Ca x P) value \< 4.44 mmol\^2/L\^2 (55 mg\^2/dL\^2) during the effectiveness assessment phase. The calcium - phosphorus product is a derived value calculated from serum calcium and phosphorus levels. |
| Number of Participants Who Achieved a Mean Calcium Value ≥ 2.1 and ≤ 2.37 mmol/L | Weeks 17 to 23 | The number of participants who achieved a mean corrected serum calcium (Ca) value ≥ 2.1 and ≤ 2.37 mmol/L (8.4 to 9.5 mg/dL) during the effectiveness assessment phase. |
| Number of Participants Who Achieved a Mean Phosphorus Value ≥ 1.13 and ≤ 1.78 mmol/L | Weeks 17 to 23 | The number of participants who achieved a mean serum phosphorus value ≥ 1.13 and ≤ 1.78 mmol/L (3.5 to 5.5 mg/dL) during the effectiveness assessment phase. |
| Number of Participants Who Achieved a Mean CRP < 0.6 mg/dL | Weeks 17 to 23 | The number of participants who achieved a mean C-reactive protein (CRP) level of \< 0.6 mg/dL during the effectiveness assessment phase. |
Participant flow
Recruitment details
Participants were enrolled from 27 October 2006 through 31 December 2008
Participants by arm
| Arm | Count |
|---|---|
| Cinacalcet Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks. | 71 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Protocol-specified criteria | 5 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Cinacalcet |
|---|---|
| Age Continuous | 62.3 Years STANDARD_DEVIATION 12.9 |
| Race/Ethnicity, Customized Aborigine | 3 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 5 Participants |
| Race/Ethnicity, Customized Other | 3 Participants |
| Race/Ethnicity, Customized White or Caucasian | 53 Participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 42 / 71 |
| serious Total, serious adverse events | 27 / 71 |
Outcome results
Primary
Number of Participants With a Mean Intact Parathyroid Hormone Value Between 150 and 300 pg/mL and a Calcium - Phosphorus Product Value < 55 mg^2/dL^2
The National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF K/DOQI) recommends that treatment interventions to control parathyroid hormone should not result in significant elevation of calcium - phosphorus product (Ca x P; a derived value calculated from serum calcium and phosphorus levels). The primary objective of the study was to assess the simultaneous achievement of NKF K/DOQI targets of intact parathyroid hormone (iPTH) greater than or equal to 15.9 pmol/L and less than or equal to 31.8 pmol/L (150 - 300 pg/mL) and a Ca x P value \< 4.44 mmol\^2/L\^2 (55 mg\^2/dL\^2) during the effectiveness assessment phase.
Time frame: Weeks 17 to 23
Population: All participants who received cinacalcet
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cinacalcet | Number of Participants With a Mean Intact Parathyroid Hormone Value Between 150 and 300 pg/mL and a Calcium - Phosphorus Product Value < 55 mg^2/dL^2 | 30 Participants |
95% CI: [30.8, 53.7]
Secondary
Number of Participants Who Achieved a Mean Calcium Value ≥ 2.1 and ≤ 2.37 mmol/L
The number of participants who achieved a mean corrected serum calcium (Ca) value ≥ 2.1 and ≤ 2.37 mmol/L (8.4 to 9.5 mg/dL) during the effectiveness assessment phase.
Time frame: Weeks 17 to 23
Population: All participants who received cinacalcet
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cinacalcet | Number of Participants Who Achieved a Mean Calcium Value ≥ 2.1 and ≤ 2.37 mmol/L | 39 Participants |
95% CI: [43.4, 66.5]
Secondary
Number of Participants Who Achieved a Mean Ca x P Value < 4.44 mmol^2/L^2 (55 mg^2/dL^2)
The number of participants who achieved a mean serum calcium x phosphorus (Ca x P) value \< 4.44 mmol\^2/L\^2 (55 mg\^2/dL\^2) during the effectiveness assessment phase. The calcium - phosphorus product is a derived value calculated from serum calcium and phosphorus levels.
Time frame: Weeks 17 to 23
Population: All participants who received cinacalcet
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cinacalcet | Number of Participants Who Achieved a Mean Ca x P Value < 4.44 mmol^2/L^2 (55 mg^2/dL^2) | 56 Participants |
95% CI: [69.4, 88.4]
Secondary
Number of Participants Who Achieved a Mean CRP < 0.6 mg/dL
The number of participants who achieved a mean C-reactive protein (CRP) level of \< 0.6 mg/dL during the effectiveness assessment phase.
Time frame: Weeks 17 to 23
Population: All participants who received cinacalcet
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cinacalcet | Number of Participants Who Achieved a Mean CRP < 0.6 mg/dL | 33 Participants |
95% CI: [34.9, 58.1]
Secondary
Number of Participants Who Achieved a Mean iPTH Value Between 150 and 300 pg/mL
Number of participants who achieved a mean intact Parathyroid Hormone (iPTH) value greater than or equal to 15.9 and less than or equal to 31.8 pmol/L (150 - 300 pg/mL) during the effectiveness assessment phase.
Time frame: Weeks 17 to 23
Population: All participants who received cinacalcet
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cinacalcet | Number of Participants Who Achieved a Mean iPTH Value Between 150 and 300 pg/mL | 37 Participants |
95% CI: [40.5, 63.7]
Secondary
Number of Participants Who Achieved a Mean Phosphorus Value ≥ 1.13 and ≤ 1.78 mmol/L
The number of participants who achieved a mean serum phosphorus value ≥ 1.13 and ≤ 1.78 mmol/L (3.5 to 5.5 mg/dL) during the effectiveness assessment phase.
Time frame: Weeks 17 to 23
Population: All participants who received cinacalcet
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cinacalcet | Number of Participants Who Achieved a Mean Phosphorus Value ≥ 1.13 and ≤ 1.78 mmol/L | 38 Participants |
95% CI: [41.9, 65.1]