Chronic Kidney Disease, Hyperparathyroidism, Secondary
Conditions
Keywords
Dialysis, Sensipar, Mimpara, Hemodialysis, Peritoneal Dialysis, Renal, Parathyroid hormone, Pediatric
Brief summary
The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).
Detailed description
This is a multicenter, 26-week, single-arm, open-label, safety study. Participants were to remain on study for 26 weeks or until time of kidney transplantation, whichever came first. The study and enrollment was placed on partial clinical hold in February 2013 which resulted in changes to the protocol. The study was restarted in April 2014 following these changes. Participants who completed the 26-week study or were on study when the study was closed in June 2016 were eligible to participate in an open-label extension study (Study 20140159; NCT02341417).
Interventions
Cinacalcet was provided as 5 mg capsules that were opened, and the contents were either sprinkled on soft food or suspended into a sucrose syrup to create a liquid suspension for administration. All doses were administered with food or shortly after a meal at the same time daily.
DRUGStandard of Care
Standard of care may have included vitamin D sterols (25 OH vitamin D and/or 1-25 OH vitamin D and its analogs) at the discretion of the investigator.
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
28 Days to 2189 Days
Healthy volunteers
No
Inclusion criteria
* Subjects between the ages of 28 days to \< 6 years of age at enrollment (Czech Republic minimum age is ≥ 2 years of age at enrollment) * Screening plasma iPTH level \> 300 pg/mL (31.8 pmol/L) from the central laboratory, and not have received any cinacalcet therapy for at least 30 days prior to start of dosing * Screening corrected calcium from the central laboratory: * ≥ 9.4 mg/dL (2.35 mmol/L) if age 28 days to \< 2 years * ≥ 8.8 (2.2 mmol/L) if age ≥ 2 to \< 6 years * Serum phosphorus from the central laboratory: * ≥ 5.0 mg/dL (1.25 mmol/L) if age 28 days to \< 1 year * ≥ 4.5 mg/dL (1.13 mmol/L) if age ≥ 1 to \< 6 years * SHPT not due to vitamin D deficiency, per investigator assessment * Dry weight ≥ 7 kg at the time of screening Exclusion criterion: * History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmias or other conditions associated with prolonged QT interval * Corrected QT interval (QTc) \> 500 ms, using Bazett's formula * QTc ≥ 450 to ≤ 500 ms, using Bazett's formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist * Use of grapefruit juice, herbal medications, or potent CYP 3A4 inhibitors (e.g., erythromycin, clarithromycin, ketoconazole, itraconazole) * Use of concomitant medications that may prolong the QTc interval (e.g., ondansetron, albuterol)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Hypocalcemia | 26 weeks | Hypocalcemia was defined as corrected serum calcium levels \< 9.0 mg/dL (2.25 mmol/L) for participants aged 28 days to \< 2 years, and \< 8.4 mg/dL (2.1 mmol/L) for participants aged ≥ 2 years to \< 6 years at any time during the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Corrected Serum Calcium Levels < 8.8 mg/dL (2.2 mmol/L) During the Study | 26 weeks | — |
| Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Baseline and weeks 3, 7, 11, 15, 19, 22, and 24 | — |
| Percent Change From Baseline in Corrected Serum Calcium | Baseline and weeks 3, 7, 11, 15, 19, 22, and 24 | — |
| Percent Change From Baseline in Serum Phosphorous | Baseline and weeks 3, 7, 11, 15, 19, 22, and 24 | — |
| Percent Change From Baseline in Calcium Phosphorus Product (Ca x P) | Baseline and weeks 3, 7, 11, 15, 19, 22, and 24 | — |
| Percentage of Participants Who Achieved > 30% Reduction in iPTH From Baseline at Any Two Consecutive Measurements | 26 weeks | A participant was considered to have achieved \> 30% reduction in iPTH from baseline at any 2 consecutive measurements if percent change of any two consecutive post-baseline iPTH values were \< -30% regardless if there was a missing value in between. |
| Percentage of Participants Who Achieved ≥ 30% Reduction in iPTH From Baseline During the Study | 26 weeks | A participant was considered to have achieved ≥ 30% reduction in iPTH if the percent change of any post-baseline iPTH value was ≤ -30% from baseline. |
| Percentage of Participants Who Achieved iPTH Values Between 200 and 300 pg/mL at Any Two Consecutive Measurements | 26 weeks | A participant was considered to have achieved iPTH between 200 and 300 pg/mL (21.2 and 31.8 pmol/L) at any 2 consecutive measurements if any two consecutive post-baseline iPTH values were within the range regardless if there was a missing value in between. The analysis included all enrolled subjects with at least 1 post-baseline assessment. |
| Percentage of Participants Who Achieved iPTH Values < 300 pg/mL During the Study | 26 weeks | A participant was considered to have achieved iPTH \< 300 pg/mL (31.8 pmol/L) during the study if any post-baseline iPTH value was \< 300 pg/mL. |
| Dose- and Weight-Normalized Maximum Plasma Concentration (Cmax) of Cinacalcet | Week 12 | — |
| Dose- and Weight-Normalized Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Cinacalcet | Week 12 | — |
Countries
Belgium, Czechia, France, Germany, Hungary, Italy, Mexico, Netherlands, New Zealand, Poland, Russia, Slovakia, United States
Participant flow
Recruitment details
The study was conducted at 14 study centers in Czech Republic (1 site), France (1 site), Germany (1 site), Italy (1 site), Slovakia (1 site), Poland (3 sites), and the United States (6 sites). The first participant was enrolled on 22 June 2012, and the last participant completed the study on 03 June 2016.
Pre-assignment details
Because of changes to the study design that were implemented after the partial clinical hold, data are presented overall and for 2 cohorts: participants enrolled before the partial clinical hold (Cohort 1) and participants enrolled after the partial clinical hold (Cohort 2).
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg. | 8 |
| Cohort 2 Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower. | 10 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative Decision | 4 | 5 |
| Overall Study | Non-compliance | 0 | 1 |
| Overall Study | Protocol-specified Criteria | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Age, Continuous | 37.1 months STANDARD_DEVIATION 18.9 | 35.0 months STANDARD_DEVIATION 15.9 | 35.9 months STANDARD_DEVIATION 16.8 |
| Age, Customized 28 days to < 2 years | 2 participants | 1 participants | 3 participants |
| Age, Customized 2 years to < 6 years | 6 participants | 9 participants | 15 participants |
| Corrected Serum Calcium | 10.56 mg/dL STANDARD_DEVIATION 0.75 | 9.82 mg/dL STANDARD_DEVIATION 0.61 | 10.15 mg/dL STANDARD_DEVIATION 0.76 |
| Intact Parathyroid Hormone | 1414.34 pg/mL STANDARD_DEVIATION 699.9 | 1206.92 pg/mL STANDARD_DEVIATION 597.85 | 1299.11 pg/mL STANDARD_DEVIATION 634.18 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Black or African American | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 participants | 2 participants | 3 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 7 participants | 8 participants | 15 participants |
| Race/Ethnicity, Customized Other | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White | 6 participants | 9 participants | 15 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 7 | 9 / 10 | 14 / 17 |
| serious Total, serious adverse events | 4 / 7 | 5 / 10 | 9 / 17 |
Outcome results
Primary
Percentage of Participants With Hypocalcemia
Hypocalcemia was defined as corrected serum calcium levels \< 9.0 mg/dL (2.25 mmol/L) for participants aged 28 days to \< 2 years, and \< 8.4 mg/dL (2.1 mmol/L) for participants aged ≥ 2 years to \< 6 years at any time during the study.
Time frame: 26 weeks
Population: The analysis included participants who received at least 1 dose of cinacalcet and had at least 1 measured serum calcium value while on cinacalcet (calcium analysis set).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Percentage of Participants With Hypocalcemia | 0.0 percentage of participants |
| Cohort 2 | Percentage of Participants With Hypocalcemia | 0.0 percentage of participants |
| Total | Percentage of Participants With Hypocalcemia | 0.0 percentage of participants |
Secondary
Dose- and Weight-Normalized Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Cinacalcet
Time frame: Week 12
Population: The Pharmacokinetic/ Pharmacodynamic (PK/PD) analysis set includes all participants who received at least one dose of study drug and had at least one evaluable PK parameter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 | Dose- and Weight-Normalized Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Cinacalcet | 160 hr*ng/mL/(mgkg) | Standard Deviation 195 |
| Cohort 2 | Dose- and Weight-Normalized Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Cinacalcet | 176.8 hr*ng/mL/(mgkg) | Standard Deviation 177 |
Secondary
Dose- and Weight-Normalized Maximum Plasma Concentration (Cmax) of Cinacalcet
Time frame: Week 12
Population: The Pharmacokinetic/ Pharmacodynamic (PK/PD) analysis set includes all participants who received at least one dose of study drug and had at least one evaluable PK parameter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 | Dose- and Weight-Normalized Maximum Plasma Concentration (Cmax) of Cinacalcet | 15.1 ng/mL/(mgkg) | Standard Deviation 16.6 |
| Cohort 2 | Dose- and Weight-Normalized Maximum Plasma Concentration (Cmax) of Cinacalcet | 17.8 ng/mL/(mgkg) | Standard Deviation 10 |
Secondary
Percentage of Participants Who Achieved > 30% Reduction in iPTH From Baseline at Any Two Consecutive Measurements
A participant was considered to have achieved \> 30% reduction in iPTH from baseline at any 2 consecutive measurements if percent change of any two consecutive post-baseline iPTH values were \< -30% regardless if there was a missing value in between.
Time frame: 26 weeks
Population: The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Percentage of Participants Who Achieved > 30% Reduction in iPTH From Baseline at Any Two Consecutive Measurements | 57.1 percentage of participants |
| Cohort 2 | Percentage of Participants Who Achieved > 30% Reduction in iPTH From Baseline at Any Two Consecutive Measurements | 40.0 percentage of participants |
| Total | Percentage of Participants Who Achieved > 30% Reduction in iPTH From Baseline at Any Two Consecutive Measurements | 47.1 percentage of participants |
Secondary
Percentage of Participants Who Achieved ≥ 30% Reduction in iPTH From Baseline During the Study
A participant was considered to have achieved ≥ 30% reduction in iPTH if the percent change of any post-baseline iPTH value was ≤ -30% from baseline.
Time frame: 26 weeks
Population: The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Percentage of Participants Who Achieved ≥ 30% Reduction in iPTH From Baseline During the Study | 100.0 percentage of participants |
| Cohort 2 | Percentage of Participants Who Achieved ≥ 30% Reduction in iPTH From Baseline During the Study | 50.0 percentage of participants |
| Total | Percentage of Participants Who Achieved ≥ 30% Reduction in iPTH From Baseline During the Study | 70.6 percentage of participants |
Secondary
Percentage of Participants Who Achieved iPTH Values < 300 pg/mL During the Study
A participant was considered to have achieved iPTH \< 300 pg/mL (31.8 pmol/L) during the study if any post-baseline iPTH value was \< 300 pg/mL.
Time frame: 26 weeks
Population: The analysis included all enrolled subjects with at least 1 post-baseline assessment (full analysis set).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Percentage of Participants Who Achieved iPTH Values < 300 pg/mL During the Study | 57.1 percentage of participants |
| Cohort 2 | Percentage of Participants Who Achieved iPTH Values < 300 pg/mL During the Study | 50.0 percentage of participants |
| Total | Percentage of Participants Who Achieved iPTH Values < 300 pg/mL During the Study | 52.9 percentage of participants |
Secondary
Percentage of Participants Who Achieved iPTH Values Between 200 and 300 pg/mL at Any Two Consecutive Measurements
A participant was considered to have achieved iPTH between 200 and 300 pg/mL (21.2 and 31.8 pmol/L) at any 2 consecutive measurements if any two consecutive post-baseline iPTH values were within the range regardless if there was a missing value in between. The analysis included all enrolled subjects with at least 1 post-baseline assessment.
Time frame: 26 weeks
Population: The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Percentage of Participants Who Achieved iPTH Values Between 200 and 300 pg/mL at Any Two Consecutive Measurements | 0.0 percentage of participants |
| Cohort 2 | Percentage of Participants Who Achieved iPTH Values Between 200 and 300 pg/mL at Any Two Consecutive Measurements | 10.0 percentage of participants |
| Total | Percentage of Participants Who Achieved iPTH Values Between 200 and 300 pg/mL at Any Two Consecutive Measurements | 5.9 percentage of participants |
Secondary
Percentage of Participants With Corrected Serum Calcium Levels < 8.8 mg/dL (2.2 mmol/L) During the Study
Time frame: 26 weeks
Population: The analysis included participants who received at least 1 dose of cinacalcet and had at least 1 measured serum calcium value while on cinacalcet (calcium analysis set).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Percentage of Participants With Corrected Serum Calcium Levels < 8.8 mg/dL (2.2 mmol/L) During the Study | 14.3 percentage of participants |
| Cohort 2 | Percentage of Participants With Corrected Serum Calcium Levels < 8.8 mg/dL (2.2 mmol/L) During the Study | 10.0 percentage of participants |
| Total | Percentage of Participants With Corrected Serum Calcium Levels < 8.8 mg/dL (2.2 mmol/L) During the Study | 11.8 percentage of participants |
Secondary
Percent Change From Baseline in Calcium Phosphorus Product (Ca x P)
Time frame: Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Population: The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set) and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Percent Change From Baseline in Calcium Phosphorus Product (Ca x P) | Week 7 (n = 4, 8, 12) | -11.56 percent change | Standard Deviation 26.35 |
| Cohort 1 | Percent Change From Baseline in Calcium Phosphorus Product (Ca x P) | Week 19 (n = 1, 2, 3) | 12.34 percent change | — |
| Cohort 1 | Percent Change From Baseline in Calcium Phosphorus Product (Ca x P) | Week 15 (n = 2, 7, 9) | 7.58 percent change | Standard Deviation 38.39 |
| Cohort 1 | Percent Change From Baseline in Calcium Phosphorus Product (Ca x P) | Week 3 (n = 7, 10, 17) | -1.89 percent change | Standard Deviation 39 |
| Cohort 1 | Percent Change From Baseline in Calcium Phosphorus Product (Ca x P) | Week 24 (n = 0, 1, 1) | NA percent change | — |
| Cohort 1 | Percent Change From Baseline in Calcium Phosphorus Product (Ca x P) | Week 22 (n = 0, 1, 1) | NA percent change | — |
| Cohort 1 | Percent Change From Baseline in Calcium Phosphorus Product (Ca x P) | Week 11 (n = 4, 8, 12) | 9.48 percent change | Standard Deviation 17.84 |
| Cohort 2 | Percent Change From Baseline in Calcium Phosphorus Product (Ca x P) | Week 15 (n = 2, 7, 9) | -14.24 percent change | Standard Deviation 28.24 |
| Cohort 2 | Percent Change From Baseline in Calcium Phosphorus Product (Ca x P) | Week 3 (n = 7, 10, 17) | -2.72 percent change | Standard Deviation 38.08 |
| Cohort 2 | Percent Change From Baseline in Calcium Phosphorus Product (Ca x P) | Week 7 (n = 4, 8, 12) | -6.83 percent change | Standard Deviation 29.97 |
| Cohort 2 | Percent Change From Baseline in Calcium Phosphorus Product (Ca x P) | Week 11 (n = 4, 8, 12) | 5.74 percent change | Standard Deviation 38.78 |
| Cohort 2 | Percent Change From Baseline in Calcium Phosphorus Product (Ca x P) | Week 19 (n = 1, 2, 3) | 6.41 percent change | Standard Deviation 9.06 |
| Cohort 2 | Percent Change From Baseline in Calcium Phosphorus Product (Ca x P) | Week 22 (n = 0, 1, 1) | 3.37 percent change | — |
| Cohort 2 | Percent Change From Baseline in Calcium Phosphorus Product (Ca x P) | Week 24 (n = 0, 1, 1) | 10.96 percent change | — |
| Total | Percent Change From Baseline in Calcium Phosphorus Product (Ca x P) | Week 19 (n = 1, 2, 3) | 8.39 percent change | Standard Deviation 7.27 |
| Total | Percent Change From Baseline in Calcium Phosphorus Product (Ca x P) | Week 7 (n = 4, 8, 12) | -8.40 percent change | Standard Deviation 27.68 |
| Total | Percent Change From Baseline in Calcium Phosphorus Product (Ca x P) | Week 24 (n = 0, 1, 1) | 10.96 percent change | — |
| Total | Percent Change From Baseline in Calcium Phosphorus Product (Ca x P) | Week 22 (n = 0, 1, 1) | 3.37 percent change | — |
| Total | Percent Change From Baseline in Calcium Phosphorus Product (Ca x P) | Week 15 (n = 2, 7, 9) | -9.39 percent change | Standard Deviation 29.58 |
| Total | Percent Change From Baseline in Calcium Phosphorus Product (Ca x P) | Week 11 (n = 4, 8, 12) | 6.99 percent change | Standard Deviation 32.36 |
| Total | Percent Change From Baseline in Calcium Phosphorus Product (Ca x P) | Week 3 (n = 7, 10, 17) | -2.37 percent change | Standard Deviation 37.23 |
Secondary
Percent Change From Baseline in Corrected Serum Calcium
Time frame: Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Population: The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set) and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Percent Change From Baseline in Corrected Serum Calcium | Week 7 (n = 4, 8, 12) | -3.58 percent change | Standard Deviation 12.23 |
| Cohort 1 | Percent Change From Baseline in Corrected Serum Calcium | Week 19 (n = 1, 3, 4) | 1.94 percent change | — |
| Cohort 1 | Percent Change From Baseline in Corrected Serum Calcium | Week 15 (n = 2, 7, 9) | -6.86 percent change | Standard Deviation 12.44 |
| Cohort 1 | Percent Change From Baseline in Corrected Serum Calcium | Week 3 (n = 7, 10, 17) | -0.50 percent change | Standard Deviation 4.47 |
| Cohort 1 | Percent Change From Baseline in Corrected Serum Calcium | Week 24 (n = 0, 1, 1) | NA percent change | — |
| Cohort 1 | Percent Change From Baseline in Corrected Serum Calcium | Week 22 (n = 0, 1, 1) | NA percent change | — |
| Cohort 1 | Percent Change From Baseline in Corrected Serum Calcium | Week 11 (n = 4, 8, 12) | -3.23 percent change | Standard Deviation 10.51 |
| Cohort 2 | Percent Change From Baseline in Corrected Serum Calcium | Week 15 (n = 2, 7, 9) | 2.99 percent change | Standard Deviation 5.09 |
| Cohort 2 | Percent Change From Baseline in Corrected Serum Calcium | Week 3 (n = 7, 10, 17) | 3.43 percent change | Standard Deviation 6.38 |
| Cohort 2 | Percent Change From Baseline in Corrected Serum Calcium | Week 7 (n = 4, 8, 12) | 3.60 percent change | Standard Deviation 9.31 |
| Cohort 2 | Percent Change From Baseline in Corrected Serum Calcium | Week 11 (n = 4, 8, 12) | 1.46 percent change | Standard Deviation 5.24 |
| Cohort 2 | Percent Change From Baseline in Corrected Serum Calcium | Week 19 (n = 1, 3, 4) | -0.49 percent change | Standard Deviation 6.62 |
| Cohort 2 | Percent Change From Baseline in Corrected Serum Calcium | Week 22 (n = 0, 1, 1) | 5.88 percent change | — |
| Cohort 2 | Percent Change From Baseline in Corrected Serum Calcium | Week 24 (n = 0, 1, 1) | 2.94 percent change | — |
| Total | Percent Change From Baseline in Corrected Serum Calcium | Week 19 (n = 1, 3, 4) | 0.12 percent change | Standard Deviation 5.54 |
| Total | Percent Change From Baseline in Corrected Serum Calcium | Week 7 (n = 4, 8, 12) | 1.21 percent change | Standard Deviation 10.41 |
| Total | Percent Change From Baseline in Corrected Serum Calcium | Week 24 (n = 0, 1, 1) | 2.94 percent change | — |
| Total | Percent Change From Baseline in Corrected Serum Calcium | Week 22 (n = 0, 1, 1) | 5.88 percent change | — |
| Total | Percent Change From Baseline in Corrected Serum Calcium | Week 15 (n = 2, 7, 9) | 0.80 percent change | Standard Deviation 7.59 |
| Total | Percent Change From Baseline in Corrected Serum Calcium | Week 11 (n = 4, 8, 12) | -0.10 percent change | Standard Deviation 7.28 |
| Total | Percent Change From Baseline in Corrected Serum Calcium | Week 3 (n = 7, 10, 17) | 1.81 percent change | Standard Deviation 5.86 |
Secondary
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Time frame: Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Population: The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set) and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Week 7 (n = 4, 9, 13) | 3.87 percent change | Standard Deviation 110.94 |
| Cohort 1 | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Week 19 (n = 1, 3, 4) | -79.02 percent change | — |
| Cohort 1 | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Week 15 (n = 2, 7, 9) | -65.31 percent change | Standard Deviation 6.83 |
| Cohort 1 | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Week 3 (n = 7, 9, 16) | -22.96 percent change | Standard Deviation 64.67 |
| Cohort 1 | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Week 24 (n = 0, 1, 1) | NA percent change | — |
| Cohort 1 | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Week 22 (n = 0, 1, 1) | NA percent change | — |
| Cohort 1 | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Week 11 (n = 4, 8, 12) | -51.70 percent change | Standard Deviation 27.18 |
| Cohort 2 | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Week 15 (n = 2, 7, 9) | -51.69 percent change | Standard Deviation 39.91 |
| Cohort 2 | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Week 3 (n = 7, 9, 16) | -3.37 percent change | Standard Deviation 54.82 |
| Cohort 2 | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Week 7 (n = 4, 9, 13) | -3.13 percent change | Standard Deviation 52.94 |
| Cohort 2 | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Week 11 (n = 4, 8, 12) | -7.15 percent change | Standard Deviation 75.3 |
| Cohort 2 | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Week 19 (n = 1, 3, 4) | -57.35 percent change | Standard Deviation 32.86 |
| Cohort 2 | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Week 22 (n = 0, 1, 1) | -78.04 percent change | — |
| Cohort 2 | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Week 24 (n = 0, 1, 1) | -67.42 percent change | — |
| Total | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Week 19 (n = 1, 3, 4) | -62.76 percent change | Standard Deviation 28.93 |
| Total | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Week 7 (n = 4, 9, 13) | -0.98 percent change | Standard Deviation 70.4 |
| Total | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Week 24 (n = 0, 1, 1) | -67.42 percent change | — |
| Total | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Week 22 (n = 0, 1, 1) | -78.04 percent change | — |
| Total | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Week 15 (n = 2, 7, 9) | -54.71 percent change | Standard Deviation 35.16 |
| Total | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Week 11 (n = 4, 8, 12) | -22.00 percent change | Standard Deviation 65.51 |
| Total | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Week 3 (n = 7, 9, 16) | -11.94 percent change | Standard Deviation 58.11 |
Secondary
Percent Change From Baseline in Serum Phosphorous
Time frame: Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Population: The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set) and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Percent Change From Baseline in Serum Phosphorous | Week 7 (n = 4, 8, 12) | -8.68 percent change | Standard Deviation 20.88 |
| Cohort 1 | Percent Change From Baseline in Serum Phosphorous | Week 19 (n = 1, 2, 3) | 10.87 percent change | — |
| Cohort 1 | Percent Change From Baseline in Serum Phosphorous | Week 15 (n = 2, 7, 9) | 13.99 percent change | Standard Deviation 26.33 |
| Cohort 1 | Percent Change From Baseline in Serum Phosphorous | Week 3 (n = 7, 10, 17) | -10.75 percent change | Standard Deviation 32.49 |
| Cohort 1 | Percent Change From Baseline in Serum Phosphorous | Week 24 (n = 0, 1, 1) | NA percent change | — |
| Cohort 1 | Percent Change From Baseline in Serum Phosphorous | Week 22 (n = 0, 1, 1) | NA percent change | — |
| Cohort 1 | Percent Change From Baseline in Serum Phosphorous | Week 11 (n = 4, 8, 12) | 14.39 percent change | Standard Deviation 22.18 |
| Cohort 2 | Percent Change From Baseline in Serum Phosphorous | Week 15 (n = 2, 7, 9) | -16.07 percent change | Standard Deviation 28.14 |
| Cohort 2 | Percent Change From Baseline in Serum Phosphorous | Week 3 (n = 7, 10, 17) | -5.11 percent change | Standard Deviation 39.32 |
| Cohort 2 | Percent Change From Baseline in Serum Phosphorous | Week 7 (n = 4, 8, 12) | -9.60 percent change | Standard Deviation 29.79 |
| Cohort 2 | Percent Change From Baseline in Serum Phosphorous | Week 11 (n = 4, 8, 12) | 4.54 percent change | Standard Deviation 39.08 |
| Cohort 2 | Percent Change From Baseline in Serum Phosphorous | Week 19 (n = 1, 2, 3) | 3.45 percent change | Standard Deviation 4.88 |
| Cohort 2 | Percent Change From Baseline in Serum Phosphorous | Week 22 (n = 0, 1, 1) | -1.72 percent change | — |
| Cohort 2 | Percent Change From Baseline in Serum Phosphorous | Week 24 (n = 0, 1, 1) | 8.62 percent change | — |
| Total | Percent Change From Baseline in Serum Phosphorous | Week 19 (n = 1, 2, 3) | 5.92 percent change | Standard Deviation 5.5 |
| Total | Percent Change From Baseline in Serum Phosphorous | Week 7 (n = 4, 8, 12) | -9.29 percent change | Standard Deviation 26.15 |
| Total | Percent Change From Baseline in Serum Phosphorous | Week 24 (n = 0, 1, 1) | 8.62 percent change | — |
| Total | Percent Change From Baseline in Serum Phosphorous | Week 22 (n = 0, 1, 1) | -1.72 percent change | — |
| Total | Percent Change From Baseline in Serum Phosphorous | Week 15 (n = 2, 7, 9) | -9.39 percent change | Standard Deviation 29.26 |
| Total | Percent Change From Baseline in Serum Phosphorous | Week 11 (n = 4, 8, 12) | 7.82 percent change | Standard Deviation 33.61 |
| Total | Percent Change From Baseline in Serum Phosphorous | Week 3 (n = 7, 10, 17) | -7.43 percent change | Standard Deviation 35.69 |