Secondary HyperparathyroidismPhase 2NCT00701805

Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Patients With Hemodialysis (HD)

A Phase 2 study testing Paricalcitol in people with Secondary Hyperparathyroidism and Hemodialysis, run by Abbott at 12 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

The purpose of this study is to evaluate the long-term safety of paricalcitol injection. Subjects will administer clinical supplies 3 times a week, 40 weeks at dialysis session in dose-titration manner, following 12 weeks of treatment in the dose-response study, M10-309 (NCT00667576). 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
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 107 participants
Where: 12 sitesJapan
Study dates: Jul 2008to Dec 2009
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

Patients who completed 12 weeks of Study M10-309 (NCT00667576).

Who cannot join

Patients taking drugs that affect intact parathyroid hormone (iPTH), calcium, or bone metabolism.
Patients with progressive malignancy or clinically significant hepatic disease.
Patients who developed severe cerebrovascular/cardiovascular disease during the dose-response portion of the study (i.e., during M10-309, NCT00667576).
Patients with uncontrolled diabetes during the dose-response portion of the study (i.e., during M10-309, NCT00667576).

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

Japan12 sites

Study site
Aichi
Study site
Chiba
Study site
Fukuoka
Study site
Hokkaido
Study site
Ibaraki
Study site
Kanagawa
Study site
Kumamoto
Study site
Nagano
Study site
Nagasaki
Study site
Osaka
Study site
Saitama
Study site
Tokyo

Other trials in Japan

About this study

Official title: Phase II Study of Paricalcitol Injection Extension Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism

Read the detailed description

The first 12-week period in this study was a dose-response study reported as Study M10-309 (NCT00667576). Only subjects who completed 12 weeks in NCT00667576 were enrolled into this study (M10-312). Baseline in this study was the same as Baseline in NCT00667576. The duration of treatment in Study M10-312 was 40 weeks (for a total of 52 weeks, including NCT00667576).

Conditions: Secondary Hyperparathyroidism, Hemodialysis
Being tested: Paricalcitol
Keywords: Secondary hyperparathyroidism, Hemodialysis, paricalcitol
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 (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis.

Study groups in NCT00701805
Study group	Role	What they receive
Paricalcitol 2 µg ± 1 µg	Experimental	Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. Receives: Drug: Paricalcitol
Paricalcitol 2 µg ± 2 µg	Experimental	Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. Receives: Drug: Paricalcitol
Paricalcitol 4 µg ± 1 µg	Experimental	Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. Receives: Drug: Paricalcitol
Paricalcitol 4 µg ± 2 µg	Experimental	Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. Receives: Drug: Paricalcitol

What is being measured

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

The Percentage of Participants With of Hypercalcemia
The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium > 11.5 mg/dL or at least 2 consecutive adjusted calcium >= 11.0 mg/dL during the 52 weeks of the study.
Measured: Anytime during the study through Week 53
The Percentage of Participants With Hyperphosphatemia
The percentage of participants with an event of hyperphosphatemia, defined as at least 2 consecutive phosphorus >= 7.0 mg/dL during the 52 weeks of the study.
Measured: Anytime during the study through Week 53

Secondary outcomes (8)

The Mean Change in Intact Parathyroid Hormone (iPTH)
Measured: From Baseline to Final Visit (which could occur anytime between study initiation and Week 53)
The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit
Measured: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)
The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50%
Measured: Anytime during the study from Baseline to the participant's final visit (which could occur anytime from study initiation to Week 53)
Change in Mean iPTH
Measured: Every week from Baseline through Week 13 and every other week thereafter until Week 53
Duration of 2 Consecutive Decreases in iPTH >= 50%
Measured: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)
Duration of 2 Consecutive iPTH Values <= 180 pg/mL
Measured: From Baseline to the participant's Final Visit (which could occur anytime between study initiation to Week 53)
The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit
Measured: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)
The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit
Measured: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)

Timeline

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

Jul 2008Dec 2009

First posted19 Jun 2008 (estimated)
Study startJul 2008
Primary completionDec 2009
Study completionDec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Secondary HyperparathyroidismStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00701805
Sponsor's protocol ID: M10-312
Status last verified: Mar 2011
First submitted: 17 Jun 2008
Last updated: 19 Apr 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
Secondary Hyperparathyroidism, Chronic Kidney Disease
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Not yet recruitingPhase 3
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism
Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
Renal Insufficiency,Chronic, Dietary Intake Patterns
Not yet recruitingObservational study
Osteoporosis & Renal Disease: Research in Primary Health Care Services
Osteoporosis, Chronic Kidney Disease Mineral and Bone Disorder

All Secondary Hyperparathyroidism trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Study of Paricalcitol Injection Extension Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism
ClinicalTrials.gov ID: NCT00701805
Acronym / sponsor ID: M10-312
Conditions: Secondary Hyperparathyroidism, Hemodialysis
Keywords: Secondary hyperparathyroidism, Hemodialysis, paricalcitol
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 107 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Collaborators: Abbott Japan Co.,Ltd
Study start: Jul 2008
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 19 Jun 2008 (estimated)
Results: Posted 19 Apr 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Paricalcitol 2 µg ± 1 µg	Experimental	Drug: ParicalcitolStudy drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
Paricalcitol 2 µg ± 2 µg	Experimental	Drug: ParicalcitolStudy drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
Paricalcitol 4 µg ± 1 µg	Experimental	Drug: ParicalcitolStudy drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
Paricalcitol 4 µg ± 2 µg	Experimental	Drug: ParicalcitolStudy drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients who completed 12 weeks of Study M10-309 (NCT00667576).

Key exclusion criteria (4 listed)

Patients taking drugs that affect intact parathyroid hormone (iPTH), calcium, or bone metabolism.
Patients with progressive malignancy or clinically significant hepatic disease.
Patients who developed severe cerebrovascular/cardiovascular disease during the dose-response portion of the study (i.e., during M10-309, NCT00667576).
Patients with uncontrolled diabetes during the dose-response portion of the study (i.e., during M10-309, NCT00667576).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ParicalcitolAlso: ABT-358, ZemplarIntravenous (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis.	Drug	Paricalcitol 2 µg ± 1 µg, Paricalcitol 2 µg ± 2 µg, Paricalcitol 4 µg ± 1 µg, Paricalcitol 4 µg ± 2 µg

Primary outcome

The Percentage of Participants With of Hypercalcemia
Time frame: Anytime during the study through Week 53
The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium > 11.5 mg/dL or at least 2 consecutive adjusted calcium >= 11.0 mg/dL during the 52 weeks of the study.
The Percentage of Participants With Hyperphosphatemia
Time frame: Anytime during the study through Week 53
The percentage of participants with an event of hyperphosphatemia, defined as at least 2 consecutive phosphorus >= 7.0 mg/dL during the 52 weeks of the study.

8 secondary outcomes

The Mean Change in Intact Parathyroid Hormone (iPTH)
Time frame: From Baseline to Final Visit (which could occur anytime between study initiation and Week 53)
The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit
Time frame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)
The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50%
Time frame: Anytime during the study from Baseline to the participant's final visit (which could occur anytime from study initiation to Week 53)
Change in Mean iPTH
Time frame: Every week from Baseline through Week 13 and every other week thereafter until Week 53
Duration of 2 Consecutive Decreases in iPTH >= 50%
Time frame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)
Duration of 2 Consecutive iPTH Values <= 180 pg/mL
Time frame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation to Week 53)
The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit
Time frame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)
The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit
Time frame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)

Results and safety

Results posted to the registry on 19 Apr 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Paricalcitol 2 µg ± 1 µg	26	23
Paricalcitol 2 µg ± 2 µg	29	25
Paricalcitol 4 µg ± 1 µg	23	16
Paricalcitol 4 µg ± 2 µg	26	22

Primary outcome: The Percentage of Participants With of Hypercalcemia

Time frame: Anytime during the study through Week 53. Number. Unit: Percentage of participants

Measure	Paricalcitol 2 µg ± 1 µg n = 27	Paricalcitol 2 µg ± 2 µg n = 30	Paricalcitol 4 µg ± 1 µg n = 23	Paricalcitol 4 µg ± 2 µg n = 26
Value	40.74	63.33	60.87	65.38

Population analysed: All subjects who received at least 1 dose of paricalcitol in this study.

Primary outcome: The Percentage of Participants With Hyperphosphatemia

Time frame: Anytime during the study through Week 53. Number. Unit: Percentage of participants

Measure	Paricalcitol 2 µg ± 1 µg n = 27	Paricalcitol 2 µg ± 2 µg n = 30	Paricalcitol 4 µg ± 1 µg n = 23	Paricalcitol 4 µg ± 2 µg n = 26
Value	40.74	36.67	26.09	38.46

Population analysed: All subjects who received at least 1 dose of paricalcitol in this study.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Paricalcitol 2 µg ± 1 µg	8 of 27 (29.6%)	27 of 27 (100%)	Not reported
Paricalcitol 2 µg ± 2 µg	6 of 30 (20%)	30 of 30 (100%)	Not reported
Paricalcitol 4 µg ± 1 µg	6 of 23 (26.1%)	23 of 23 (100%)	Not reported
Paricalcitol 4 µg ± 2 µg	4 of 26 (15.4%)	26 of 26 (100%)	Not reported

Limitations and caveats (from the sponsor): The dose titration scheme was revised because of the incidence of hypercalcemia in the early weeks of the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
prescribing informationLink provided by the sponsor.

Related trials for Secondary Hyperparathyroidism

RecruitingPhase 3
Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
Secondary Hyperparathyroidism, Chronic Kidney Disease
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Not yet recruitingPhase 3
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism
Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
Renal Insufficiency,Chronic, Dietary Intake Patterns
Not yet recruitingObservational study
Osteoporosis & Renal Disease: Research in Primary Health Care Services
Osteoporosis, Chronic Kidney Disease Mineral and Bone Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Moriaki KUBO study director

Abbott

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paricalcitol in people with Secondary Hyperparathyroidism and Hemodialysis, run by Abbott at 12 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 1 inclusion and 4 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 19 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 19 Apr 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 of Hypercalcemia (time frame: Anytime during the study through Week 53). The study lists 2 primary outcomes in all. 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 NCT00701805.

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 19 Apr 2011.