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Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.

Participants received maxacalcitol at an initial dose of 5 µg (iPTH \< 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.

paricalcitol

maxacalcitol

paricalcitol placebo

maxacalcitol placebo

Kazuya Kobayashi, BA

This study is a comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in adult Japanese chronic kidney disease patients receiving hemodialysis with secondary hyperparathyroidism. The main objective of this study is to demonstrate the efficacy of paricalcitol injection in reducing levels of parathyroid hormone without clinically significant hypercalcemia, compared to maxacalcitol injection.

Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism

The target iPTH range was 60-180 pg/mL, based on the average of the last 3 weeks of treatment, and with no hypercalcemia during the treatment phase. Hypercalcemia was defined as at least 1 corrected calcium value \> 11.0 mg/dL or at least 2 corrected calcium values ≥ 10.5 mg/dL. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.

The percentage of participants with greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks of treatment and with no hypercalcemia during the treatment phase. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory. Hypercalcemia was defined as at least 1 corrected calcium value \> 11.0 mg/dL or at least 2 corrected calcium values ≥ 10.5 mg/dL.

The target iPTH range was 60-180 pg/mL, based on the average of the last 3 weeks of treatment. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.

The percentage of participants with a greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks of treatment. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.

iPTH control was defined as a ≥ 50% reduction from baseline. iPTH was measured before the first dialysis session of the week, each week during the treatment phase and analyzed by the central laboratory.

iPTH control was defined as being within the target range of 60 to 180 pg/mL. iPTH was measured before the first dialysis session of the week, once a week during the treatment phase and analyzed by the central laboratory.

AbbVie (prior sponsor, Abbott)

Paricalcitol

Total

Age Continuous

Sex: Female, Male

Asian

Other

Race/Ethnicity, Customized

Japan

Region of Enrollment

Duration of hemodialysis

Intact parathyroid hormone level

Global Medical Services

The per-protocol set (PPS) consists of all randomized patients who completed at least 8 weeks of treatment and met the conditions specified by the subject classification (i.e., no violation of inclusion/exclusion criteria) that occurred before the study blind was broken.

Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) and Without Hypercalcemia

The Full Analysis Set (FAS) consists of all randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline iPTH measurement.

Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline and With No Hypercalcemia

Percentage of Participants With Target Intact Parathyroid Hormone (iPTH)

Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline

Number of Visits at Which Participants Achieved iPTH Control With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline

Number of Visits at Which Participants Achieved iPTH Control in the Target Range of 60 to 180 pg/mL

Participants received maxacalcitol at an initial dose of 5 µg (intact parathyroid hormone \[iPTH\] \< 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.

Overall Study

2 mcg adjusted by +/- 1 mcg, up to a maximum of 7 mcg, administered 3 times per week through intravenous catheter immediately before completion of dialysis

5 or 10 mcg adjusted by +/- 2.5 mcg, up to a maximum of 20 mcg, administered 3 times per week through intravenous catheter immediately before completion of dialysis

Intravenous administration 3 times a week immediately before completion of dialysis

Moriaki Kubo

This study is a exploratory comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in chronic kidney disease participants receiving hemodialysis with secondary hyperparathyroidism.

Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism

Phase II, Open Study, Exploratory Examination of Efficacy and Safety of Paricalcitol Injection and Maxacalcitol Injection in Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism

Hypercalcemia was defined as at least 1 corrected calcium \> 11.5 mg/dL or at least 2 consecutive corrected calcium \>= 11.0 mg/dL.

Abbott

Yoshihiko Ueki

Age, Categorical

All subjects who received at least 1 dose of study drug and who had at least 1 iPTH measurement while on treatment.

The Percentage of Participants With a >=50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline Compared to the Average iPTH Obtained in the Last 3 Weeks.

The Percentage of Participants With iPTH Within Target Range of 60-180 pg/mL, Based on the Average iPTH Obtained in the Last 3 Weeks

Screening (up to 2 weeks before Baseline)

Baseline (Week 1)

Week 2

Week 3

Week 4

Week 5

Week 6

Week 7

Week 8

Week 9

Week 10

Week 11

Week 12

Week 13

Mean iPTH at Each Visit

Mean Change in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks

Percentage of Participants With a >= 50% Reduction in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks and Without Hypercalcemia During Treatment

Percentage of Participants With iPTH Within the Target Range of 60-180 pg/mL Based on the Average iPTH Obtained in the Last 3 Weeks of the Study and Without Hypercalcemia Anytime During Treatment

Number of Occurrences of iPTH Control, Defined as >=50% Reduction in iPTH From Baseline

Number of Occurrences of iPTH Control, Defined as Within the Target Range of 60-180 pg/mL of iPTH

Paricalcitol initial dosage 2 micrograms (µg) with incremental adjustment of 1 µg

Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg

Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg

Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg

Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg

Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 12 weeks.

Ryotaro Matsuzawa

The purpose of this study was to investigate the initial dose and dose adjustment range for paricalcitol injection in patients with chronic kidney disease on hemodialysis who have secondary hyperparathyroidism.

This multicenter, randomized, open-label trial consisted of 4 dose-adjustment regimens for paricalcitol injection (initial doses and dose adjustment ranges were 2 ± 1 µg, 2 ± 2 µg, 4 ± 1 µg, and 4 ± 2 µg) and 1 maxacalcitol regimen (initial dose and dose adjustment range was 5 µg ± 2.5 µg or 10 µg ± 2.5 µg) as a reference group. Subjects who met the inclusion criteria were randomized equally to 1 of the treatment groups with iPTH values at screening (\< 500 pg/mL or ≥ 500 pg/mL) as a dynamic allocation factor. Study drugs were administered 3 times weekly (every other day) from the venous end of the hemodialysis circuit just before completion of the dialysis session. The initial doses were continued for 2 weeks, followed by dose adjustments (increase, maintenance, decrease, suspension, or resumption) by 1 µg or 2 µg units for the paricalcitol groups and by 2.5 µg units for the maxacalcitol group based on iPTH, calcium (adjusted), and phosphorus values every 2 weeks.

Subjects in the paricalcitol groups were to be suspended from treatment if their iPTH value decreased to \< 60 pg/mL in accordance with the guidelines proposed by the Japanese Society of Dialysis Therapy for the treatment of secondary hyperparathyroidism in chronic dialysis patients (control goal value of 60-180 pg/mL for iPTH). The dose adjustment criteria based on iPTH values for the maxacalcitol group were set according to the prescribing information for maxacalcitol (suspended when iPTH decreased to ≤ 150 pg/mL).

Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Patients Receiving Hemodialysis

Late Phase 2 Study of Paricalcitol Injection: Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism (Examination of Initial Dose and Incremental Dose)

Hypercalcemia was defined as at least 1 adjusted calcium value \> 11.5 mg/dL or at least 2 consecutive adjusted calcium values ≥ 11.0 mg/dL

Hyperphosphatemia was defined as at least 2 consecutive phosphorus values ≥ 7.0 mg/dL

Abbott Japan Co.,Ltd

The investigator recorded any undesirable medical events (adverse events) during the study period based on medical interview of the subject, information from medical staff, or spontaneous reporting by the subject.

Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg

Paricalcitol 2 µg ± 1 µg

Paricalcitol 2 µg ± 2 µg

Paricalcitol 4 µg ± 1 µg

Paricalcitol 4 µg ± 2 µg

Maxacalcitol 5 or 10 µg ± 2.5 µg

Different PTH thresholds were applied for suspending study drug: paricalcitol groups \<60 pg/mL, maxacalcitol group ≤150 pg/mL. This study was not statistically powered to compare treatments.

The efficacy analysis was performed on the full analysis set (FAS). The FAS included all treated patients, except for 1 subject from the paricalcitol 4 ± 2 µg group who discontinued the study without measurement of iPTH after the first drug injection. Missing data were not imputed.

Percentage of Subjects With ≥ 50% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Serum Level

Safety analysis was performed on the Safety Set, which included all subjects who received at least 1 dose of study drug. Missing data were not imputed.

Percentage of Subjects With Hypercalcemia

Percentage of Subjects With Hyperphosphatemia

Mean Change From Baseline in Intact Parathyroid Hormone (iPTH) Level

Percentage of Subjects With Intact Parathyroid Hormone (iPTH) ≤ 180 Picograms/Milliliter (pg/mL)

The efficacy analysis was performed on the full analysis set (FAS). The FAS included all treated subjects, except for 1 subject from the paricalcitol 4 ± 2 µg group who discontinued the study without measurement of iPTH after the first drug injection. Missing data were not imputed.

Percentage of Subjects With 2 or More Decreases of ≥ 50% From Baseline in Intact Parathyroid Hormone (iPTH) Level

Includes subjects from the Full Analysis Set (FAS) who had 2 consecutive iPTH decreases of ≥ 50% from baseline. Missing data were not imputed.

Duration of 2 Consecutive Decreases of ≥ 50% From Baseline in Intact Parathyroid Hormone (iPTH) Values

Includes subjects from the Full Analysis Set (FAS) who had 2 consecutive iPTH values ≤ 180 pg/mL. Missing data were not imputed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism	NCT01341782	Secondary Hyper... Hemodialysis	paricalcitol maxacalcitol paricalcitol pl... maxacalcitol pl...	20 Years -	AbbVie
Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism	NCT00990704	Secondary Hyper... Hemodialysis	paricalcitol maxacalcitol	20 Years -	Abbott
Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism	NCT00990704	Secondary Hyper... Hemodialysis	paricalcitol maxacalcitol	20 Years -	Abbott
Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Patients Receiving Hemodialysis	NCT00667576	Chronic Kidney ... Secondary Hyper...	Maxacalcitol Paricalcitol	20 Years -	Abbott
Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism	NCT00990704	Secondary Hyper... Hemodialysis	paricalcitol maxacalcitol	20 Years -	Abbott

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