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Secondary HyperparathyroidismPhase 3NCT01341782

Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism

A Phase 3 study testing paricalcitol and maxacalcitol in people with Secondary Hyperparathyroidism and Hemodialysis, run by AbbVie (prior sponsor, Abbott) at 45 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 comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in adult Japanese chronic kidney disease patients 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?
Yes, some participants may receive a placebo
How many people
255 participants
Where
45 sitesJapan
Study dates
May 2011to Apr 2012
Phase
Phase 3
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

  • Adult Chronic Kidney Disease (CKD) Stage 5 patients undergoing dialysis with stable dialysate calcium and phosphate binders
  • On three times weekly hemodialysis for at least 3 months prior with intact parathyroid hormone (iPTH) greater than or equal to 300 pg/mL, adjusted normalized serum total calcium (Ca) greater than or equal to 8.4 to less than 10.2 mg/dL, serum phosphorus (P) less than or equal to 6.5 mg/dL.

Who cannot join

  • Patients with a recent history of severe cardiovascular or hepatic disease, uncontrolled hypertension or uncontrolled diabetes
  • Patients who have received a parathyroidectomy or ethanol infusion within the prior year
  • Patients taking drugs that affect iPTH, calcium or bone metabolism
  • Patients who will need to take chronic doses (greater than or equal to 2 consecutive weeks) of cytochrome P450 inhibitors (e.g., clarithromycin, grapefruit products) or inducers (e.g., carbamazepine, rifampicin)
  • Female patients who are pregnant, possibly pregnant, wish to become pregnant, or participate in breastfeeding during the study period.

Trial locations and contacts

45 sites in 1 country.

45 sites in 1 country

Japan45 sites

  • Site Reference ID/Investigator# 53485

    Aichi

  • Site Reference ID/Investigator# 51571

    Chiba

  • Site Reference ID/Investigator# 52963

    Chiba

  • Site Reference ID/Investigator# 52966

    Chiba

  • Site Reference ID/Investigator# 51578

    Gifu

  • Site Reference ID/Investigator# 52965

    Gunma

  • Site Reference ID/Investigator# 53782

    Hadano

  • Site Reference ID/Investigator# 57483

    Himeji

  • Site Reference ID/Investigator# 57487

    Hokkaido

  • Site Reference ID/Investigator# 53484

    Hyōgo

  • Site Reference ID/Investigator# 54385

    Ibaraki

  • Site Reference ID/Investigator# 51581

    Kagawa

  • Site Reference ID/Investigator# 59164

    Kagoshima

  • Site Reference ID/Investigator# 51574

    Kanagawa

  • Site Reference ID/Investigator# 51575

    Kanagawa

  • Site Reference ID/Investigator# 52751

    Kodaira

  • Site Reference ID/Investigator# 62025

    Koga

  • Site Reference ID/Investigator# 54384

    Matsumoto

  • Site Reference ID/Investigator# 52745

    Midori

  • Site Reference ID/Investigator# 51569

    Mito

  • Site Reference ID/Investigator# 52964

    Nagano

  • Site Reference ID/Investigator# 53483

    Nagano

  • Site Reference ID/Investigator# 51582

    Nagasaki

  • Site Reference ID/Investigator# 54388

    Nagoya

  • Site Reference ID/Investigator# 51576

    Niigata

  • Site Reference ID/Investigator# 51577

    Niigata

  • Site Reference ID/Investigator# 51580

    Osaka

  • Site Reference ID/Investigator# 52747

    Osaka

  • Site Reference ID/Investigator# 52748

    Osaka

  • Site Reference ID/Investigator# 52750

    Osaka

  • Site Reference ID/Investigator# 51570

    Saitama

  • Site Reference ID/Investigator# 54387

    Sakai

  • Site Reference ID/Investigator# 52746

    Sapporo

  • Site Reference ID/Investigator# 51579

    Shizuoka

  • Site Reference ID/Investigator# 62024

    Takasaki

  • Site Reference ID/Investigator# 51572

    Tokyo

  • Site Reference ID/Investigator# 52752

    Tokyo

  • Site Reference ID/Investigator# 53482

    Tokyo

  • Site Reference ID/Investigator# 59162

    Tokyo

  • Site Reference ID/Investigator# 59966

    Tokyo

  • Site Reference ID/Investigator# 53783

    Tomakomai-shi

  • Site Reference ID/Investigator# 54383

    Toyama

  • Site Reference ID/Investigator# 52749

    Wakayama

  • Site Reference ID/Investigator# 52962

    Yachiyoshi

  • Site Reference ID/Investigator# 59163

    Yokohama

Other trials in Japan

About this study

This study is a comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in adult Japanese chronic kidney disease patients receiving hemodialysis with secondary hyperparathyroidism. The main objective of this study is to demonstrate the efficacy of paricalcitol injection in reducing levels of parathyroid hormone without clinically significant hypercalcemia, compared to maxacalcitol injection.

Being tested
paricalcitol, maxacalcitol, paricalcitol placebo, maxacalcitol placebo
Keywords
Secondary hyperparathyroidism, Paricalcitol, Hemodialysis, 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

  • maxacalcitolDrug

    Also called oxarol

  • paricalcitol placeboDrug

  • maxacalcitol placeboDrug

Study groups in NCT01341782
Study groupRoleWhat they receive
ParicalcitolExperimentalParticipants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
Receives: Drug: paricalcitol; Drug: maxacalcitol placebo
MaxacalcitolActive comparatorParticipants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
Receives: Drug: maxacalcitol; Drug: paricalcitol placebo

What is being measured

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

  1. Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) and Without Hypercalcemia

    The target iPTH range was 60-180 pg/mL, based on the average of the last 3 weeks of treatment, and with no hypercalcemia during the treatment phase. Hypercalcemia was defined as at least 1 corrected calcium value > 11.0 mg/dL or at least 2 corrected calcium values ≥ 10.5 mg/dL. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.

    Measured: iPTH measured during the last three weeks of treatment (Weeks 11, 12, and 13). Calcium measured throughout the study (Weeks 1-13).

Secondary outcomes (5)

  1. Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline and With No Hypercalcemia

    The percentage of participants with greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks of treatment and with no hypercalcemia during the treatment phase. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory. Hypercalcemia was defined as at least 1 corrected calcium value > 11.0 mg/dL or at least 2 corrected calcium values ≥ 10.5 mg/dL.

    Measured: Baseline to the last three weeks of treatment (Weeks 11, 12, and 13) for iPTH. Calcium measured throughout the study (Weeks 1-13).

  2. Percentage of Participants With Target Intact Parathyroid Hormone (iPTH)

    The target iPTH range was 60-180 pg/mL, based on the average of the last 3 weeks of treatment. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.

    Measured: The last three weeks of treatment (Weeks 11, 12, and 13)

  3. Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline

    The percentage of participants with a greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks of treatment. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.

    Measured: Baseline to the last three weeks of treatment (Weeks 11, 12, and 13)

  4. Number of Visits at Which Participants Achieved iPTH Control With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline

    iPTH control was defined as a ≥ 50% reduction from baseline. iPTH was measured before the first dialysis session of the week, each week during the treatment phase and analyzed by the central laboratory.

    Measured: Weeks 2 to 13

  5. Number of Visits at Which Participants Achieved iPTH Control in the Target Range of 60 to 180 pg/mL

    iPTH control was defined as being within the target range of 60 to 180 pg/mL. iPTH was measured before the first dialysis session of the week, once a week during the treatment phase and analyzed by the central laboratory.

    Measured: Weeks 2 to 13

Timeline

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

  1. First posted26 Apr 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionApr 2012
  4. Study completionApr 2012

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
255 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01341782
Sponsor's protocol ID
M11-517
Status last verified
Apr 2013
First submitted
25 Apr 2011
Last updated
6 Jun 2013
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing paricalcitol and maxacalcitol in people with Secondary Hyperparathyroidism and Hemodialysis, run by AbbVie (prior sponsor, Abbott) at 45 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 2 inclusion and 5 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 6 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 6 Jun 2013). 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?

Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) and Without Hypercalcemia (time frame: iPTH measured during the last three weeks of treatment (Weeks 11, 12, and 13). Calcium measured throughout the study (Weeks 1-13).). 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 NCT01341782.

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 6 Jun 2013.

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