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

Hemodialysis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01341782
• Other study ID #: M11-517
• Status: Completed
• Phase: Phase 3
• First received: April 25, 2011
• Last updated: April 17, 2013
• Start date: May 2011
• Est. completion date: April 2012

Study information

• Verified date: April 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodialysis
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Neoplasm Metastasis
• Renal Insufficiency, Chronic
• Secondary Hyperparathyroidism

Intervention

Drug:
• paricalcitol

• maxacalcitol

• paricalcitol placebo

• maxacalcitol placebo

Locations

Country	Name	City	State
Japan	Site Reference ID/Investigator# 53485	Aichi
Japan	Site Reference ID/Investigator# 51571	Chiba
Japan	Site Reference ID/Investigator# 52963	Chiba
Japan	Site Reference ID/Investigator# 52966	Chiba
Japan	Site Reference ID/Investigator# 51578	Gifu
Japan	Site Reference ID/Investigator# 52965	Gunma
Japan	Site Reference ID/Investigator# 53782	Hadano-City
Japan	Site Reference ID/Investigator# 57483	Himeji-City
Japan	Site Reference ID/Investigator# 57487	Hokkaido
Japan	Site Reference ID/Investigator# 53484	Hyogo
Japan	Site Reference ID/Investigator# 54385	Ibaraki
Japan	Site Reference ID/Investigator# 51581	Kagawa
Japan	Site Reference ID/Investigator# 59164	Kagoshima
Japan	Site Reference ID/Investigator# 51574	Kanagawa
Japan	Site Reference ID/Investigator# 51575	Kanagawa
Japan	Site Reference ID/Investigator# 52751	Kodaira
Japan	Site Reference ID/Investigator# 62025	Koga
Japan	Site Reference ID/Investigator# 54384	Matsumoto
Japan	Site Reference ID/Investigator# 52745	Midori
Japan	Site Reference ID/Investigator# 51569	Mito
Japan	Site Reference ID/Investigator# 52964	Nagano
Japan	Site Reference ID/Investigator# 53483	Nagano
Japan	Site Reference ID/Investigator# 51582	Nagasaki
Japan	Site Reference ID/Investigator# 54388	Nagoya
Japan	Site Reference ID/Investigator# 51576	Niigata
Japan	Site Reference ID/Investigator# 51577	Niigata
Japan	Site Reference ID/Investigator# 51580	Osaka
Japan	Site Reference ID/Investigator# 52747	Osaka
Japan	Site Reference ID/Investigator# 52748	Osaka
Japan	Site Reference ID/Investigator# 52750	Osaka
Japan	Site Reference ID/Investigator# 51570	Saitama
Japan	Site Reference ID/Investigator# 54387	Sakai
Japan	Site Reference ID/Investigator# 52746	Sapporo
Japan	Site Reference ID/Investigator# 51579	Shizuoka
Japan	Site Reference ID/Investigator# 62024	Takasaki
Japan	Site Reference ID/Investigator# 51572	Tokyo
Japan	Site Reference ID/Investigator# 52752	Tokyo
Japan	Site Reference ID/Investigator# 53482	Tokyo
Japan	Site Reference ID/Investigator# 59162	Tokyo
Japan	Site Reference ID/Investigator# 59966	Tokyo
Japan	Site Reference ID/Investigator# 53783	Tomakomai-shi
Japan	Site Reference ID/Investigator# 54383	Toyama
Japan	Site Reference ID/Investigator# 52749	Wakayama
Japan	Site Reference ID/Investigator# 52962	Yachiyoshi
Japan	Site Reference ID/Investigator# 59163	Yokohama-Shi

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) and Without Hypercalcemia	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.	iPTH measured during the last three weeks of treatment (Weeks 11, 12, and 13). Calcium measured throughout the study (Weeks 1-13).	Yes
Secondary	Percentage of Participants With = 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline and With No Hypercalcemia	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.	Baseline to the last three weeks of treatment (Weeks 11, 12, and 13) for iPTH. Calcium measured throughout the study (Weeks 1-13).	Yes
Secondary	Percentage of Participants With Target Intact Parathyroid Hormone (iPTH)	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 last three weeks of treatment (Weeks 11, 12, and 13)	No
Secondary	Percentage of Participants With = 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline	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.	Baseline to the last three weeks of treatment (Weeks 11, 12, and 13)	No
Secondary	Number of Visits at Which Participants Achieved iPTH Control With = 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline	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.	Weeks 2 to 13	No
Secondary	Number of Visits at Which Participants Achieved iPTH Control in the Target Range of 60 to 180 pg/mL	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.	Weeks 2 to 13	No

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