Phase 3 N=216 Randomized Single-blind Treatment

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

Chronic Kidney Disease

Bottom Line

View on ClinicalTrials.gov: NCT01071070 ↗

Enrolled (actual)

216

Serious AEs

1.4%

Results posted

Jan 2012

Primary outcome: Primary: The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels — 93; 57; 12; 45 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: paricalcitol (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Abbott
Primary completion: Nov 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels	93; 57; 12; 45	—
SECONDARY The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value Between 150 and 300 pg/mL	19; 21; 89; 87	—
SECONDARY The Change From Baseline to the Final Observation in Intact Parathyroid Hormone Value	-342.57; -191.53	—
SECONDARY The Change From Baseline to the Final Observation in Calcium	0.64; 0.59	—
SECONDARY The Change From Baseline to the Final Observation in Calcium-phosphorus Product	7.53; 8.15	—
SECONDARY The Change From Baseline to the Final Observation in the Vital Sign of Systolic Blood Pressure	-1.47; -1.75	—
SECONDARY The Change From Baseline to the Final Observation in the Vital Sign of Diastolic Blood Pressure	-1.47; -0.32	—
SECONDARY The Change From Baseline to the Final Observation in the Vital Sign of Heart Rate	0.51; -0.89	—
SECONDARY The Proportion of Subjects With 2 Consecutive Calcium Measurements Greater Than 11.0 mg/dL (2.75 mmol/L)	1; 0; 107; 108	—

Summary

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

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01071070). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.