Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism

Abbott

Status and phase: Completed; Phase 2

Conditions: Hemodialysis; Secondary Hyperparathyroidism

Treatments: Drug: paricalcitol; Drug: maxacalcitol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00990704

M11-609

Details and patient eligibility

About

This study is a exploratory comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in chronic kidney disease participants receiving hemodialysis with secondary hyperparathyroidism.

Enrollment: 47 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic kidney disease (CKD) patients with iPTH >=300 pg/mL, adjusted calcium >=8.4 to <10.2 mg/dL, and phosphorus <=6.5 mg/dL
• Patients receiving dialysis 3 times weekly for at least 3 months before informed consent was obtained and scheduled to receive the same hemodialysis during the study period
• Patients using dialysate with constant concentration of calcium for 4 weeks before informed consent was obtained and receiving phosphate binder with constant dose regimen for 2 weeks before informed consent was obtained

Exclusion criteria

• Patients taking drugs that affect iPTH, calcium, or bone metabolism

• Patients with a history of allergic reaction or significant sensitivity to vitamin D

• Patients who received parathyroidectomy or ethanol infusion within 1 year before informed consent was obtained

• Patients with malignancy or with clinically significant hepatic disease (liver function tests more than 3 times the upper limit of normal) or with refractory hepatic disease

• Patients with cardiovascular disease designated as New York Heart Association Class III or IV or with any of the following cardiovascular or cerebrovascular diseases within 6 months before informed consent was obtained:

  • Acute coronary syndrome (myocardial infarction or unstable angina) or acute cerebral vascular disease (cerebral infarction or cerebral hemorrhage)
  • Coronary arterial revascularization (such as coronary artery bypass grafting, percutaneous transluminal coronary angioplasty)
  • Cerebral arterial revascularization (such as cerebral aneurysm clipping, cerebral aneurysm embolization, carotid artery endarterectomy)
  • Arteriosclerosis obliterans with rest pain (Fontaine classification III or more severe)

• Patients with severe hypertension (defined as mean resting blood pressure taken with the patient in a supine position before dialysis and at 6 dialyses sessions before informed consent was obtained: systolic >= 180 mmHg and diastolic >= 110 mmHg)

• Patients with uncontrolled diabetes mellitus (defined as mean glycosylated hemoglobin >=8% for 3 months before informed consent was obtained)

• Patients with a history of drug or alcohol abuse within 6 months before informed consent was obtained

• Patients who require chronic use of cytochrome P450 (CYP3A) inhibitors or inducers

• Patients who are taking products that contain aluminum 2 weeks before informed consent was obtained

• Patients who have taken paricalcitol in the past

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

Paricalcitol

Experimental group

Description:

2 mcg adjusted by +/- 1 mcg, up to a maximum of 7 mcg, administered 3 times per week through intravenous catheter immediately before completion of dialysis

Treatment:

Drug: paricalcitol

Maxacalcitol

Active Comparator group

Description:

5 or 10 mcg adjusted by +/- 2.5 mcg, up to a maximum of 20 mcg, administered 3 times per week through intravenous catheter immediately before completion of dialysis

Treatment:

Drug: maxacalcitol