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Completed

NCT Number: NCT00990704

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

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.

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Key information

Conditions

Secondary Hyperparathyroidism Endocrine System Diseases Hemodialysis Hyperparathyroidism Hyperparathyroidism, Secondary Parathyroid Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site Ref # / Investigator 53794, Anjo, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paricalcitol

Drug

Intravenous administration 3 times a week immediately before completion of dialysis

Other names: ABT-358, Zemplar

maxacalcitol

Drug

Intravenous administration 3 times a week immediately before completion of dialysis

Primary outcomes

  1. The Percentage of Participants With a >=50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline Compared to the Average iPTH Obtained in the Last 3 Weeks.

    Time frame: Baseline and the last 3 weeks (Weeks 11, 12, and 13)

Secondary outcomes

  1. The Percentage of Participants With iPTH Within Target Range of 60-180 pg/mL, Based on the Average iPTH Obtained in the Last 3 Weeks

    Time frame: During the last 3 weeks (Weeks 11, 12, and 13)

  2. Mean iPTH at Each Visit

    Time frame: Screening (up to 2 weeks before Baseline) to Week 13

  3. Mean Change in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks

    Time frame: Baseline and the last 3 weeks (Weeks 11, 12, and 13)

  4. Percentage of Participants With a >= 50% Reduction in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks and Without Hypercalcemia During Treatment

    Time frame: Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia

    Hypercalcemia was defined as at least 1 corrected calcium > 11.5 mg/dL or at least 2 consecutive corrected calcium >= 11.0 mg/dL.

  5. Percentage of Participants With iPTH Within the Target Range of 60-180 pg/mL Based on the Average iPTH Obtained in the Last 3 Weeks of the Study and Without Hypercalcemia Anytime During Treatment

    Time frame: Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia

    Hypercalcemia was defined as at least 1 corrected calcium > 11.5 mg/dL or at least 2 consecutive corrected calcium >= 11.0 mg/dL.

  6. Number of Occurrences of iPTH Control, Defined as >=50% Reduction in iPTH From Baseline

    Time frame: Over the 12-week treatment period

  7. Number of Occurrences of iPTH Control, Defined as Within the Target Range of 60-180 pg/mL of iPTH

    Time frame: Over the 12-week treatment period

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

Phase II, Open Study, Exploratory Examination of Efficacy and Safety of Paricalcitol Injection and Maxacalcitol Injection in Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 7, 2009
Registry last updated
Jul 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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