Clinical trial NCT01341782: Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism
Official title: Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Secondary Hyperparathyroidism
Hemodialysis
Keywords: Secondary hyperparathyroidism
Paricalcitol
Hemodialysis
Maxacalcitol
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2011-04-26
Enrollment: 255
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Adult Chronic Kidney Disease (CKD) Stage 5 patients undergoing dialysis with stable dialysate calcium and phosphate binders
* On three times weekly hemodialysis for at least 3 months prior with intact parathyroid hormone (iPTH) greater than or equal to 300 pg/mL, adjusted normalized serum total calcium (Ca) greater than or equal to 8.4 to less than 10.2 mg/dL, serum phosphorus (P) less than or equal to 6.5 mg/dL.

Exclusion Criteria:

* Patients with a recent history of severe cardiovascular or hepatic disease, uncontrolled hypertension or uncontrolled diabetes
* Patients who have received a parathyroidectomy or ethanol infusion within the prior year
* Patients taking drugs that affect iPTH, calcium or bone metabolism
* Patients who will need to take chronic doses (greater than or equal to 2 consecutive weeks) of cytochrome P450 inhibitors (e.g., clarithromycin, grapefruit products) or inducers (e.g., carbamazepine, rifampicin)
* Female patients who are pregnant, possibly pregnant, wish to become pregnant, or participate in breastfeeding during the study period.

Primary outcomes:
measure: Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) and Without Hypercalcemia
timeFrame: iPTH measured during the last three weeks of treatment (Weeks 11, 12, and 13). Calcium measured throughout the study (Weeks 1-13).
Secondary outcomes:
measure: Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline and With No Hypercalcemia
timeFrame: Baseline to the last three weeks of treatment (Weeks 11, 12, and 13) for iPTH. Calcium measured throughout the study (Weeks 1-13).
measure: Percentage of Participants With Target Intact Parathyroid Hormone (iPTH)
timeFrame: The last three weeks of treatment (Weeks 11, 12, and 13)
measure: Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline
timeFrame: Baseline to the last three weeks of treatment (Weeks 11, 12, and 13)
measure: Number of Visits at Which Participants Achieved iPTH Control With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline
timeFrame: Weeks 2 to 13
measure: Number of Visits at Which Participants Achieved iPTH Control in the Target Range of 60 to 180 pg/mL
timeFrame: Weeks 2 to 13
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Site Reference ID/Investigator# 53485
city: Chiba
country: Japan
facility: Site Reference ID/Investigator# 51571
city: Chiba
country: Japan
facility: Site Reference ID/Investigator# 52963
city: Chiba
country: Japan
facility: Site Reference ID/Investigator# 52966
city: Gifu
country: Japan
facility: Site Reference ID/Investigator# 51578
city: Gunma
country: Japan
facility: Site Reference ID/Investigator# 52965
city: Hadano-City
country: Japan
facility: Site Reference ID/Investigator# 53782
city: Himeji-City
country: Japan
facility: Site Reference ID/Investigator# 57483
city: Hokkaido
country: Japan
facility: Site Reference ID/Investigator# 57487
city: Hyogo
country: Japan
facility: Site Reference ID/Investigator# 53484
city: Ibaraki
country: Japan
facility: Site Reference ID/Investigator# 54385
city: Kagawa
country: Japan
facility: Site Reference ID/Investigator# 51581
city: Kagoshima
country: Japan
facility: Site Reference ID/Investigator# 59164
city: Kanagawa
country: Japan
facility: Site Reference ID/Investigator# 51574
city: Kanagawa
country: Japan
facility: Site Reference ID/Investigator# 51575
city: Kodaira
country: Japan
facility: Site Reference ID/Investigator# 52751
city: Koga
country: Japan
facility: Site Reference ID/Investigator# 62025
city: Matsumoto
country: Japan
facility: Site Reference ID/Investigator# 54384
city: Midori
country: Japan
facility: Site Reference ID/Investigator# 52745
city: Mito
country: Japan
facility: Site Reference ID/Investigator# 51569
city: Nagano
country: Japan
facility: Site Reference ID/Investigator# 52964
city: Nagano
country: Japan
facility: Site Reference ID/Investigator# 53483
city: Nagasaki
country: Japan
facility: Site Reference ID/Investigator# 51582
city: Nagoya
country: Japan
facility: Site Reference ID/Investigator# 54388
city: Niigata
country: Japan
facility: Site Reference ID/Investigator# 51576
city: Niigata
country: Japan
facility: Site Reference ID/Investigator# 51577
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 51580
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 52747
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 52748
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 52750
city: Saitama
country: Japan
facility: Site Reference ID/Investigator# 51570
city: Sakai
country: Japan
facility: Site Reference ID/Investigator# 54387
city: Sapporo
country: Japan
facility: Site Reference ID/Investigator# 52746
city: Shizuoka
country: Japan
facility: Site Reference ID/Investigator# 51579
city: Takasaki
country: Japan
facility: Site Reference ID/Investigator# 62024
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 51572
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 52752
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 53482
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 59162
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 59966
city: Tomakomai-shi
country: Japan
facility: Site Reference ID/Investigator# 53783
city: Toyama
country: Japan
facility: Site Reference ID/Investigator# 54383
city: Wakayama
country: Japan
facility: Site Reference ID/Investigator# 52749
city: Yachiyoshi
country: Japan
facility: Site Reference ID/Investigator# 52962
city: Yokohama-Shi
country: Japan
facility: Site Reference ID/Investigator# 59163
Study officials:
affiliation: AbbVie
name: Kazuya Kobayashi, BA
role: STUDY_DIRECTOR
References: