Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

A Phase 3b, Randomized, Active-Controlled, Single-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Paricalcitol Injection in Reducing Serum Intact Parathyroid Hormone Levels in Chronic Kidney Disease Stage 5 Subjects Receiving Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01071070
• Other study ID #: M06-823
• Status: Completed
• Phase: Phase 3
• First received: November 25, 2009
• Last updated: December 20, 2011
• Start date: November 2009
• Est. completion date: November 2010

Study information

• Verified date: December 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease

Description:

Evaluate the safety and efficacy of paricalcitol injection with two different dosing regimens (currently approved dosing regimen used in the US package insert versus dosing based on a formula of iPTH/80 that was approved and used in the EU package insert) in Chronic Kidney Disease (CKD) Stage 5 subjects with secondary hyperparathyroidism receiving hemodialysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Subject is a Chinese male or female greater than or equal to 20 years old.

2. Subject is diagnosed with Chronic Kidney Disease Stage 5 and must be on maintenance hemodialysis three times a week for at least 2 months prior to the Screening Visit and expected to remain on hemodialysis for the duration of the study.

3. For entry into the Treatment Phase, the subject must have:

• Intact parathyroid hormone greater than or equal to 300 pg/mL

• Serum calcium less than 10.2 mg/dL (2.55 mmol/L)

• Calcium-phosphorus product less than 65 mg^2/dL^2

Exclusion Criteria:

1. Subject has a history of an allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds.

2. Subject received a partial parathyroidectomy within one year prior to the Screening Phase.

3. Subject with New York Heart Association (NYHA) Class III or IV.

4. Subject has taken aluminum-containing phosphate binders for greater than 3 weeks in the last 3 months prior to the Screening Phase, or requires such medications for greater than 3 weeks in the study.

5. Subject has a current malignancy (with the exception of basal or squamous cell carcinoma of the skin), or clinically significant liver disease, in the opinion of the Investigator.

6. Subject has a history of drug or alcohol abuse within 6 months prior to the Screening Phase.

7. Subject is known to be human immunodeficiency virus (HIV) positive.

8. Subject has evidence of poor compliance with diet, medication or hemodialysis that may interfere, in the Investigator's opinion, with adherence to the protocol.

Study Design

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• paricalcitol
Initiation dosing based on 2 approved package inserts , followed by a dose adjusted by limited chemistry test value. See Arm Description for additional details.

Locations

Country	Name	City	State
China	Site Reference ID/Investigator# 23482	Beijing
China	Site Reference ID/Investigator# 23483	Beijing
China	Site Reference ID/Investigator# 23485	Beijing
China	Site Reference ID/Investigator# 23484	Dalian City
China	Site Reference ID/Investigator# 23486	Guangzhou City
China	Site Reference ID/Investigator# 23488	Nanjing
China	Site Reference ID/Investigator# 37722	Qingdao
China	Site Reference ID/Investigator# 23487	Shanghai
China	Site Reference ID/Investigator# 23489	Shanghai
China	Site Reference ID/Investigator# 23490	Shanghai
China	Site Reference ID/Investigator# 25502	Shanghai
China	Site Reference ID/Investigator# 35822	Wenzhou

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels	The number of participants who achieved (Yes) or did not achieve (No) two consecutive decreases of greater than or equal to 30% from baseline in intact parathyroid hormone (iPTH) values	Baseline to 12 Weeks	No
Secondary	The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value Between 150 and 300 pg/mL	The number of subjects with (Yes) or without (No) final intact parathyroid hormone (iPTH) values between 150 and 300 pg/mL	Baseline to 12 Weeks	No
Secondary	The Change From Baseline to the Final Observation in Intact Parathyroid Hormone Value		Baseline to 12 Weeks	Yes
Secondary	The Change From Baseline to the Final Observation in Calcium		Baseline to 12 Weeks	Yes
Secondary	The Change From Baseline to the Final Observation in Calcium-phosphorus Product		Baseline to 12 Weeks	Yes
Secondary	The Change From Baseline to the Final Observation in the Vital Sign of Systolic Blood Pressure		Baseline to 12 Weeks	Yes
Secondary	The Change From Baseline to the Final Observation in the Vital Sign of Diastolic Blood Pressure		Baseline to 12 Weeks	Yes
Secondary	The Change From Baseline to the Final Observation in the Vital Sign of Heart Rate		Baseline to 12 Weeks	Yes
Secondary	The Proportion of Subjects With 2 Consecutive Calcium Measurements Greater Than 11.0 mg/dL (2.75 mmol/L)	The number of subjects with (Yes) or without (No) two consecutive calcium measurements greater than 11.0 mg/dL (2.75 mmol/L)	Baseline to 12 weeks	Yes