Secondary Hyperparathyroidism
Conditions
Keywords
Clinical Trial, Phase 2, Renal Dialysis, Secondary Hyperparathyroidism, Chronic kidney disease-mineral and bone disorder, Parathyroid hormone
Brief summary
The purpose of this study is to evaluate the long term safety and efficacy of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in patients receiving hemodialysis who had completed 12 weeks of treatment with etelcalcetide in parent study 20120331 (KAI-4169-005; NCT01414114).
Interventions
DRUGEtelcalcetide
Administered as an intravenous bolus three times a week at the end of each hemodialysis session at dosages up to a maximum of 15 mg.
Sponsors
KAI Pharmaceuticals
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
* Subject provides written informed consent. * Subject completed the 12 week treatment phase in the parent study study 20120331 ( KAI-4169-005; NCT01414114).
Exclusion criteria
* Subject pregnant or nursing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events | From the first dose of study drug in the parent study (20120331) through 30 days after the last dose in the extension study; actual median duration of treatment was 439 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Parathyroid Hormone | Baseline (of the parent study 20120331) and Weeks 13, 26 and 52 | Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of etelcalcetide in the parent study (20120331). The week numbering for this study continued from the parent study 20120331 hence the first measurement for all parameters in the extension study started at week 13. |
| Percent Change From Baseline in Serum Corrected Calcium | Baseline and Weeks 13, 26 and 52 | Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of study drug in the parent study (20120331). The week numbering for this study continued from the parent study 20120331; the first measurement for all parameters in the extension study started at week 13. |
| Percent Change From Baseline in Serum Phosphorus | Baseline and Weeks 13, 26 and 52 | Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of study drug in the parent study (20120331). The week numbering for this study continued from the parent study 20120331; the first measurement for all parameters in the extension study started at week 13. |
Participant flow
Recruitment details
This open-label extension study was conducted at 5 centers in the United States. Eligible participants must have completed 12 weeks of treatment in parent study 20120331 (KAI-4169-005; NCT01414114).
Pre-assignment details
This study consisted of 40 weeks of treatment in extension period 1 followed by 2 years of additional treatment in extension period 2. The Sponsor ended the study early. Participants had the opportunity to rollover into another open-label extension study 20130213 (NCT02102204).
Participants by arm
| Arm | Count |
|---|---|
| Etelcalcetide Participants received a bolus intravenous (IV) injection of etelcalcetide 3 times a week (TIW) at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Extension Period 1 | Adverse Event | 2 |
| Extension Period 1 | Death | 2 |
| Extension Period 1 | Lost to Follow-up | 1 |
| Extension Period 1 | Parathyroidectomy | 1 |
| Extension Period 1 | Physician Decision | 2 |
| Extension Period 1 | Renal Transplant | 1 |
| Extension Period 1 | Withdrawal by Subject | 1 |
| Extension Period 2 | Adverse Event | 1 |
| Extension Period 2 | Death | 1 |
| Extension Period 2 | Renal Transplant | 1 |
| Extension Period 2 | Sponsor Decision | 13 |
| Extension Period 2 | Treatment Not Resumed Within 8 Weeks | 1 |
Baseline characteristics
| Characteristic | Etelcalcetide |
|---|---|
| Age, Continuous | 55.4 years STANDARD_DEVIATION 14.2 |
| Ethnicity Hispanic/Latino | 6 Participants |
| Ethnicity Not Hispanic/Latino | 24 Participants |
| Parathyroid Hormone | 862.1 pg/mL STANDARD_DEVIATION 672 |
| Race Black (or African American) | 18 Participants |
| Race White | 12 Participants |
| Serum Corrected Calcium | 10.21 mg/dL STANDARD_DEVIATION 0.53 |
| Serum Phosphorus | 5.77 mg/dL STANDARD_DEVIATION 1.5 |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 27 / 30 |
| serious Total, serious adverse events | 18 / 30 |
Outcome results
Primary
Number of Participants With Adverse Events
Time frame: From the first dose of study drug in the parent study (20120331) through 30 days after the last dose in the extension study; actual median duration of treatment was 439 days.
Population: Participants who received at least one dose of etelcalcetide in the extension study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etelcalcetide | Number of Participants With Adverse Events | Any adverse event (AE) | 30 participants |
| Etelcalcetide | Number of Participants With Adverse Events | Serious adverse events | 18 participants |
| Etelcalcetide | Number of Participants With Adverse Events | Treatment-related adverse events | 13 participants |
| Etelcalcetide | Number of Participants With Adverse Events | Treatment-related serious adverse events | 1 participants |
| Etelcalcetide | Number of Participants With Adverse Events | AEs leading to discontinuation of treatment | 3 participants |
| Etelcalcetide | Number of Participants With Adverse Events | Fatal adverse events | 4 participants |
Secondary
Percent Change From Baseline in Parathyroid Hormone
Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of etelcalcetide in the parent study (20120331). The week numbering for this study continued from the parent study 20120331 hence the first measurement for all parameters in the extension study started at week 13.
Time frame: Baseline (of the parent study 20120331) and Weeks 13, 26 and 52
Population: The full analysis set (all participants who received at least 1 dose during the extension study) with data collected on or before the last non-missing dose of etelcalcetide (defined as on-treatment approach).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etelcalcetide | Percent Change From Baseline in Parathyroid Hormone | Week 13 | -57.8 percent change | Standard Error 4 |
| Etelcalcetide | Percent Change From Baseline in Parathyroid Hormone | Week 26 | -61.0 percent change | Standard Error 5.2 |
| Etelcalcetide | Percent Change From Baseline in Parathyroid Hormone | Week 52 | -51.7 percent change | Standard Error 6.8 |
Secondary
Percent Change From Baseline in Serum Corrected Calcium
Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of study drug in the parent study (20120331). The week numbering for this study continued from the parent study 20120331; the first measurement for all parameters in the extension study started at week 13.
Time frame: Baseline and Weeks 13, 26 and 52
Population: The full analysis set (all participants who received at least 1 dose during the extension study) with data collected on or before the last non-missing dose of etelcalcetide (defined as on-treatment approach).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etelcalcetide | Percent Change From Baseline in Serum Corrected Calcium | Week 13 | -16.16 percent change | Standard Error 1.26 |
| Etelcalcetide | Percent Change From Baseline in Serum Corrected Calcium | Week 26 | -13.09 percent change | Standard Error 1.02 |
| Etelcalcetide | Percent Change From Baseline in Serum Corrected Calcium | Week 52 | -11.69 percent change | Standard Error 1.38 |
Secondary
Percent Change From Baseline in Serum Phosphorus
Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of study drug in the parent study (20120331). The week numbering for this study continued from the parent study 20120331; the first measurement for all parameters in the extension study started at week 13.
Time frame: Baseline and Weeks 13, 26 and 52
Population: The full analysis set (all participants who received at least 1 dose during the extension study) with data collected on or before the last non-missing dose of etelcalcetide (defined as on-treatment approach).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etelcalcetide | Percent Change From Baseline in Serum Phosphorus | Week 13 | -10.39 percent change | Standard Error 3.85 |
| Etelcalcetide | Percent Change From Baseline in Serum Phosphorus | Week 26 | 4.13 percent change | Standard Error 5.5 |
| Etelcalcetide | Percent Change From Baseline in Serum Phosphorus | Week 52 | 2.46 percent change | Standard Error 4.39 |