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Secondary HyperparathyroidismPhase 2NCT00990704

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

A Phase 2 study testing paricalcitol and maxacalcitol in people with Secondary Hyperparathyroidism and Hemodialysis, run by Abbott at 14 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Secondary Hyperparathyroidism, Hemodialysis
What is being tested?
paricalcitol and maxacalcitol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
14 sitesJapan
Study dates
Oct 2009to May 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 15Show fewer
  • 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 locations and contacts

14 sites in 1 country.

14 sites in 1 country

Japan14 sites

  • Site Ref # / Investigator 53794

    Anjo

  • Site Ref # / Investigator 53787

    Chiba

  • Site Ref # / Investigator 53786

    Kumagaya

  • Site Ref # / Investigator 53792

    Matsumoto

  • Site Ref # / Investigator 53784

    Mito

  • Site Ref # / Investigator 53796

    Nagasaki

  • Site Ref # / Investigator 53795

    Osaka

  • Site Ref # / Investigator 21561

    Sapporo

  • Site Ref # / Investigator 53789

    Tokyo

  • Site Ref # / Investigator 53790

    Tokyo

  • Site Ref # / Investigator 53793

    Toyohashi

  • Site Ref # / Investigator 53785

    Tsuchiura

  • Site Ref # / Investigator 53788

    Yachiyo

  • Site Ref # / Investigator 53791

    Yokosuka

Other trials in Japan

About this study

Official 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

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.

Being tested
paricalcitol, maxacalcitol
Keywords
Secondary hyperparathyroidism, Hemodialysis, paricalcitol, maxacalcitol
Medical subject headings
Hyperparathyroidism, Secondary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • paricalcitolDrug

    Also called ABT-358, Zemplar

    Intravenous administration 3 times a week immediately before completion of dialysis

  • maxacalcitolDrug

    Intravenous administration 3 times a week immediately before completion of dialysis

Study groups in NCT00990704
Study groupRoleWhat they receive
ParicalcitolExperimental2 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
Receives: Drug: paricalcitol
MaxacalcitolActive comparator5 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
Receives: Drug: maxacalcitol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (7)

  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

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

  2. Mean iPTH at Each Visit

    Measured: 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

    Measured: 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

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

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

  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

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

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

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

    Measured: 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

    Measured: Over the 12-week treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionMay 2010
  4. Study completionMay 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00990704
Sponsor's protocol ID
M11-609
Status last verified
Jun 2011
First submitted
5 Oct 2009
Last updated
11 Jul 2011
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing paricalcitol and maxacalcitol in people with Secondary Hyperparathyroidism and Hemodialysis, run by Abbott at 14 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00990704.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2011.

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