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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: paricalcitol

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100034
    • Site Reference ID/Investigator# 23483
  • Beijing, China, 100044
    • Site Reference ID/Investigator# 23485
  • Beijing, China, 100730
    • Site Reference ID/Investigator# 23482
  • Dalian City, China, 116011
    • Site Reference ID/Investigator# 23484
  • Guangzhou City, China, 510080
    • Site Reference ID/Investigator# 23486
  • Nanjing, China, 210029
    • Site Reference ID/Investigator# 23488
  • Qingdao, China, 266003
    • Site Reference ID/Investigator# 37722
  • Shanghai, China, 200001
    • Site Reference ID/Investigator# 23490
  • Shanghai, China, 200001
    • Site Reference ID/Investigator# 25502
  • Shanghai, China, 200025
    • Site Reference ID/Investigator# 23489
  • Shanghai, China, 200092
    • Site Reference ID/Investigator# 23487
  • Wenzhou, China, 325000
    • Site Reference ID/Investigator# 35822

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).	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.; Other Names: Zemplar; ABT-358
Active Comparator: Group 2; Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)	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.; Other Names: Zemplar; ABT-358

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
The Change From Baseline to the Final Observation in Intact Parathyroid Hormone Value		Baseline to 12 Weeks
The Change From Baseline to the Final Observation in Calcium		Baseline to 12 Weeks
The Change From Baseline to the Final Observation in Calcium-phosphorus Product		Baseline to 12 Weeks
The Change From Baseline to the Final Observation in the Vital Sign of Systolic Blood Pressure		Baseline to 12 Weeks
The Change From Baseline to the Final Observation in the Vital Sign of Diastolic Blood Pressure		Baseline to 12 Weeks
The Change From Baseline to the Final Observation in the Vital Sign of Heart Rate		Baseline to 12 Weeks
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

Collaborators and Investigators

• Sponsor: Abbott
• Investigators: Study Director: Yue Kang, MD, Abbott (China)

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: November 25, 2009
• First Submitted That Met QC Criteria: February 17, 2010
• First Posted (Estimate): February 19, 2010

Study Record Updates

• Last Update Posted (Estimate): January 26, 2012
• Last Update Submitted That Met QC Criteria: December 20, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; Secondary hyperparathyroidism
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: M06-823