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

Phase 3

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: paricalcitol

• Registration Number: NCT01071070
• Lead Sponsor: Abbott

Brief Summary

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

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 Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-25
• Study First Submitted QC: 2010-02-17
• Study First Posted: 2010-02-19
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Results First Submitted: 2011-11-07
• Status Verified: 2011-12
• Results First Submitted QC: 2011-12-20
• Last Update Submitted: 2011-12-20
• Results First Posted: 2012-01-26
• Last Update Posted: 2012-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 1	paricalcitol	Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
Group 2	paricalcitol	Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)

Primary Outcome Measures

Name	Time	Method
The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels	Baseline to 12 Weeks	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

Secondary Outcome Measures

Name	Time	Method
The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value Between 150 and 300 pg/mL	Baseline to 12 Weeks	The number of subjects with (Yes) or without (No) final intact parathyroid hormone (iPTH) values between 150 and 300 pg/mL
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)	Baseline to 12 weeks	The number of subjects with (Yes) or without (No) two consecutive calcium measurements greater than 11.0 mg/dL (2.75 mmol/L)

Trial Locations

Locations (12)

Site Reference ID/Investigator# 35822; 🇨🇳 Wenzhou, China

Site Reference ID/Investigator# 37722; 🇨🇳 Qingdao, China

Site Reference ID/Investigator# 23485; 🇨🇳 Beijing, China

Site Reference ID/Investigator# 23484; 🇨🇳 Dalian City, China

Site Reference ID/Investigator# 23482; 🇨🇳 Beijing, China

Site Reference ID/Investigator# 23483; 🇨🇳 Beijing, China

Site Reference ID/Investigator# 23486; 🇨🇳 Guangzhou City, China

Site Reference ID/Investigator# 23490; 🇨🇳 Shanghai, China

Site Reference ID/Investigator# 25502; 🇨🇳 Shanghai, China

Site Reference ID/Investigator# 23489; 🇨🇳 Shanghai, China

Site Reference ID/Investigator# 23487; 🇨🇳 Shanghai, China

Site Reference ID/Investigator# 23488; 🇨🇳 Nanjing, China