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

NCT01071070 | Completed Phase 3 Results

• 1 other identifier: M06-823
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney Disease; Secondary hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value 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

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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

Group 2

ACTIVE COMPARATOR

Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)

Drug: paricalcitol

Interventions

paricalcitol DRUG

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

Also known as: ABT-358, Zemplar

Group 1; Group 2

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (12)

Site Reference ID/Investigator# 23483

Beijing, 100034, China

Location

Site Reference ID/Investigator# 23485

Beijing, 100044, China

Location

Site Reference ID/Investigator# 23482

Beijing, 100730, China

Location

Site Reference ID/Investigator# 23484

Dalian, 116011, China

Location

Site Reference ID/Investigator# 23486

Guangzhou, 510080, China

Location

Site Reference ID/Investigator# 23488

Nanjing, 210029, China

Location

Site Reference ID/Investigator# 37722

Qingdao, 266003, China

Location

Site Reference ID/Investigator# 23490

Shanghai, 200001, China

Location

Site Reference ID/Investigator# 25502

Shanghai, 200001, China

Location

Site Reference ID/Investigator# 23489

Shanghai, 200025, China

Location

Site Reference ID/Investigator# 23487

Shanghai, 200092, China

Location

Site Reference ID/Investigator# 35822

Wenzhou, 325000, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperparathyroidism, Secondary

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

800-633-9110

Study Officials

• Yue Kang, MD

  Abbott (China)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2009
• First Posted: February 19, 2010
• Study Start: November 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: January 26, 2012
• Results First Posted: January 26, 2012

Record last verified: 2011-12

Locations

CN (12)