Clinical trial NCT01071070: Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease
Secondary hyperparathyroidism
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-02-19
Enrollment: 216
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels
timeFrame: Baseline to 12 Weeks
Secondary outcomes:
measure: The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value Between 150 and 300 pg/mL
timeFrame: Baseline to 12 Weeks
measure: The Change From Baseline to the Final Observation in Intact Parathyroid Hormone Value
timeFrame: Baseline to 12 Weeks
measure: The Change From Baseline to the Final Observation in Calcium
timeFrame: Baseline to 12 Weeks
measure: The Change From Baseline to the Final Observation in Calcium-phosphorus Product
timeFrame: Baseline to 12 Weeks
measure: The Change From Baseline to the Final Observation in the Vital Sign of Systolic Blood Pressure
timeFrame: Baseline to 12 Weeks
measure: The Change From Baseline to the Final Observation in the Vital Sign of Diastolic Blood Pressure
timeFrame: Baseline to 12 Weeks
measure: The Change From Baseline to the Final Observation in the Vital Sign of Heart Rate
timeFrame: Baseline to 12 Weeks
measure: The Proportion of Subjects With 2 Consecutive Calcium Measurements Greater Than 11.0 mg/dL (2.75 mmol/L)
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Site Reference ID/Investigator# 23483
city: Beijing
country: China
facility: Site Reference ID/Investigator# 23485
city: Beijing
country: China
facility: Site Reference ID/Investigator# 23482
city: Dalian City
country: China
facility: Site Reference ID/Investigator# 23484
city: Guangzhou City
country: China
facility: Site Reference ID/Investigator# 23486
city: Nanjing
country: China
facility: Site Reference ID/Investigator# 23488
city: Qingdao
country: China
facility: Site Reference ID/Investigator# 37722
city: Shanghai
country: China
facility: Site Reference ID/Investigator# 23490
city: Shanghai
country: China
facility: Site Reference ID/Investigator# 25502
city: Shanghai
country: China
facility: Site Reference ID/Investigator# 23489
city: Shanghai
country: China
facility: Site Reference ID/Investigator# 23487
city: Wenzhou
country: China
facility: Site Reference ID/Investigator# 35822
Study officials:
affiliation: Abbott (China)
name: Yue Kang, MD
role: STUDY_DIRECTOR
References: