Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease - Full Text View

Purpose

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

Condition	Intervention	Phase
Chronic Kidney Disease	Drug: paricalcitol	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Chronic Kidney Disease

Drug Information available for: Parathyroid Hormone Paricalcitol

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels [ Time Frame: Baseline to 12 Weeks ] [ Designated as safety issue: No ]
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:

The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value Between 150 and 300 pg/mL [ Time Frame: Baseline to 12 Weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline to 12 Weeks ] [ Designated as safety issue: Yes ]
The Change From Baseline to the Final Observation in Calcium [ Time Frame: Baseline to 12 Weeks ] [ Designated as safety issue: Yes ]
The Change From Baseline to the Final Observation in Calcium-phosphorus Product [ Time Frame: Baseline to 12 Weeks ] [ Designated as safety issue: Yes ]
The Change From Baseline to the Final Observation in the Vital Sign of Systolic Blood Pressure [ Time Frame: Baseline to 12 Weeks ] [ Designated as safety issue: Yes ]
The Change From Baseline to the Final Observation in the Vital Sign of Diastolic Blood Pressure [ Time Frame: Baseline to 12 Weeks ] [ Designated as safety issue: Yes ]
The Change From Baseline to the Final Observation in the Vital Sign of Heart Rate [ Time Frame: Baseline to 12 Weeks ] [ Designated as safety issue: Yes ]
The Proportion of Subjects With 2 Consecutive Calcium Measurements Greater Than 11.0 mg/dL (2.75 mmol/L) [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: Yes ]
The number of subjects with (Yes) or without (No) two consecutive calcium measurements greater than 11.0 mg/dL (2.75 mmol/L)

Enrollment:	216
Study Start Date:	November 2009
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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: ABT-358 paricalcitol Zemplar
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: ABT-358 paricalcitol Zemplar

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

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Subject has a history of an allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds.
Subject received a partial parathyroidectomy within one year prior to the Screening Phase.
Subject with New York Heart Association (NYHA) Class III or IV.
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.
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.
Subject has a history of drug or alcohol abuse within 6 months prior to the Screening Phase.
Subject is known to be human immunodeficiency virus (HIV) positive.
Subject has evidence of poor compliance with diet, medication or hemodialysis that may interfere, in the Investigator's opinion, with adherence to the protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01071070

Locations

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

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Yue Kang, MD

Abbott (China)

More Information

No publications provided

Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT01071070 History of Changes
Other Study ID Numbers:	M06-823
Study First Received:	November 25, 2009
Results First Received:	November 7, 2011
Last Updated:	December 20, 2011
Health Authority:	China: Food and Drug Administration

Keywords provided by Abbott:

Chronic Kidney Disease
Secondary hyperparathyroidism

Additional relevant MeSH terms:

Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Hormones
Ergocalciferols

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on June 17, 2013