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

Antineoplastic Agents

Dermatologic Agents

Calcium

Calcium, Dietary

Maxacalcitol

Protective Agents

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.

Paricalcitol

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

Abbott

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

Total

Age, Categorical

Age Continuous

Sex: Female, Male

Japan

Region of Enrollment

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.

Global Medical Services

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.

Spots Global Cancer Trial Database for chronic kidney disease on hemodialysis