Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Neoplasms

Symptoms and General Pathology

Gland and Hormone Related Diseases

Rare Diseases

Kidney Diseases

Neoplasm Metastasis

Hyperparathyroidism

Hyperparathyroidism, Secondary

Renal Insufficiency, Chronic

Renal Insufficiency

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Chronic Disease

Disease Attributes

Neoplastic Processes

Parathyroid Diseases

Endocrine System Diseases

Chronic Graft Versus Host Disease

All Drugs and Chemicals

Bone Density Conservation Agents

Calcium

Calcium, Dietary

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 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.

Intravenous (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis.

Paricalcitol

Moriaki KUBO

The purpose of this study is to evaluate the long-term safety of paricalcitol injection. Subjects will administer clinical supplies 3 times a week, 40 weeks at dialysis session in dose-titration manner, following 12 weeks of treatment in the dose-response study, M10-309 (NCT00667576).

The first 12-week period in this study was a dose-response study reported as Study M10-309 (NCT00667576). Only subjects who completed 12 weeks in NCT00667576 were enrolled into this study (M10-312). Baseline in this study was the same as Baseline in NCT00667576. The duration of treatment in Study M10-312 was 40 weeks (for a total of 52 weeks, including NCT00667576).

Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Patients With Hemodialysis (HD)

Phase II Study of Paricalcitol Injection Extension Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism

The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium \> 11.5 mg/dL or at least 2 consecutive adjusted calcium \>= 11.0 mg/dL during Study M10-312 (Weeks 13 through 53)

The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium \> 11.5 mg/dL or at least 2 consecutive adjusted calcium \>= 11.0 mg/dL during the 52 weeks of the study.

The percentage of participants with an event of hyperphosphatemia, defined as at least 2 consecutive phosphorus \>= 7.0 mg/dL during the 52 weeks of the study.

Abbott Japan Co.,Ltd

Abbott

Yoshihiko Ueki

Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.

Paricalcitol 2 µg ± 1 µg

Paricalcitol 2 µg ± 2 µg

Paricalcitol 4 µg ± 1 µg

Paricalcitol 4 µg ± 2 µg

Total

Age, Categorical

Age Continuous

Sex: Female, Male

Japan

Region of Enrollment

The dose titration scheme was revised because of the incidence of hypercalcemia in the early weeks of the study.

Global Medical Services

All subjects who received at least 1 dose of paricalcitol in this study.

The Percentage of Participants With of Hypercalcemia

The Percentage of Participants With Hyperphosphatemia

All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.

The Mean Change in Intact Parathyroid Hormone (iPTH)

Subjects with iPTH <= 180 pg/mL

Subjects with decrease in iPTH >= 50%

The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit

The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50%

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

Week 15

Week 17

Week 19

Week 21

Week 23

Week 25

Week 27

Week 29

Week 31

Week 33

Week 35

Week 37

Week 39

Week 41

Week 43

Week 45

Week 47

Week 49

Week 51

Week 53

Change in Mean iPTH

Duration of 2 Consecutive Decreases in iPTH >= 50%

Duration of 2 Consecutive iPTH Values <= 180 pg/mL

The Percentage of Participants With Hypercalcemia

All subjects who received at least 1 dose of paricalcitol in this study and who had abnormal alkaline phosphatase at Baseline.

The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit

All subjects who received at least 1 dose of paricalcitol in this study and who had abnormal BSAP at Baseline.

The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit

Overall Study

Spots Global Cancer Trial Database for Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Patients With Hemodialysis (HD)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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