Chronic Kidney Disease on HemodialysisPhase 2NCT00667576
Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Patients Receiving Hemodialysis
A Phase 2 study testing Maxacalcitol and Paricalcitol in people with Chronic Kidney Disease on Hemodialysis and Secondary Hyperparathyroidism, run by Abbott at 12 sites in Japan.
Trial summary
The purpose of this study was to investigate the initial dose and dose adjustment range for paricalcitol injection in patients with chronic kidney disease on hemodialysis who have secondary hyperparathyroidism. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Kidney Disease on Hemodialysis, Secondary Hyperparathyroidism
- What is being tested?
- Maxacalcitol and Paricalcitol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 12 sitesJapan
- Study dates
- Apr 2008to Mar 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
- Diagnosed with chronic kidney disease receiving hemodialysis 3 times a week for at least 3 months prior to obtaining the informed consent and scheduled to be receiving the same hemodialysis during the study period.
- Using dialysate with constant concentration of calcium for 4 weeks prior to obtaining informed consent and phosphate binder with constant dose regimen for 2 weeks prior to obtaining informed consent.
- Intact parathyroid hormone level (iPTH) ≥ 300 pg/mL
- Calcium (adjusted) 8.4-10.2 milligrams/deciliter (mg/dL)
- Phosphorus ≤ 6.5 mg/dL
- Age ≥ 20 years
Who cannot join
- History of allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds
- Parathyroidectomy or ethanol infusion within past year
- Progressive malignancy or clinically significant hepatic diseases, severe cerebral/cardiovascular diseases, severe hypertension, or uncontrolled diabetes mellitus
- Drug or alcohol abuse within past 6 months
- Taking calcitonin, maintenance intravenous or oral glucocorticoids, cinacalcet, bisphosphonates, selective estrogen-receptor modulator (SERM), vitamin D compounds (other than study drug), or other drugs that may affect calcium or bone metabolism (other than estrogen or progestin, vitamin K2)
- Will need to take chronic dose (≥ 2 consecutive weeks) of cytochrome P450 (CYP3A) inhibitors (e.g., clarithromycin, grapefruit products) or inducers (e.g., carbamazepine, rifampicin)
- Taking aluminum containing products (2 weeks prior to consent)
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Japan12 sites
Study site
Aichi, Prefecture
Study site
Chiba, Prefecture
Study site
Fukuoka, Prefecture
Study site
Hokkaido, Prefecture
Study site
Ibaraki, Prefecture
Study site
Kanagawa, Prefecture
Study site
Kumamoto, Prefecture
Study site
Nagano, Prefecture
Study site
Nagasaki, Prefecture
Study site
Osaka, Prefecture
Study site
Saitama, Prefecture
Study site
Tokyo, Metropolis
About this study
Official title: Late Phase 2 Study of Paricalcitol Injection: Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism (Examination of Initial Dose and Incremental Dose)
The purpose of this study was to investigate the initial dose and dose adjustment range for paricalcitol injection in patients with chronic kidney disease on hemodialysis who have secondary hyperparathyroidism.
Read the detailed description
This multicenter, randomized, open-label trial consisted of 4 dose-adjustment regimens for paricalcitol injection (initial doses and dose adjustment ranges were 2 ± 1 µg, 2 ± 2 µg, 4 ± 1 µg, and 4 ± 2 µg) and 1 maxacalcitol regimen (initial dose and dose adjustment range was 5 µg ± 2.5 µg or 10 µg ± 2.5 µg) as a reference group. Subjects who met the inclusion criteria were randomized equally to 1 of the treatment groups with iPTH values at screening (< 500 pg/mL or ≥ 500 pg/mL) as a dynamic allocation factor. Study drugs were administered 3 times weekly (every other day) from the venous end of the hemodialysis circuit just before completion of the dialysis session. The initial doses were continued for 2 weeks, followed by dose adjustments (increase, maintenance, decrease, suspension, or resumption) by 1 µg or 2 µg units for the paricalcitol groups and by 2.5 µg units for the maxacalcitol group based on iPTH, calcium (adjusted), and phosphorus values every 2 weeks.
Subjects in the paricalcitol groups were to be suspended from treatment if their iPTH value decreased to < 60 pg/mL in accordance with the guidelines proposed by the Japanese Society of Dialysis Therapy for the treatment of secondary hyperparathyroidism in chronic dialysis patients (control goal value of 60-180 pg/mL for iPTH). The dose adjustment criteria based on iPTH values for the maxacalcitol group were set according to the prescribing information for maxacalcitol (suspended when iPTH decreased to ≤ 150 pg/mL).
- Being tested
- Maxacalcitol, Paricalcitol
- Keywords
- chronic kidney disease, secondary hyperparathyroidism, hemodialysis, paricalcitol, maxacalcitol
- Medical subject headings
- Hyperparathyroidism, Secondary, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaxacalcitolDrug
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 12 weeks.
ParicalcitolDrug
Also called ABT-358, Zemplar
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 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Paricalcitol 2 µg ± 1 µg | Experimental | Paricalcitol initial dosage 2 micrograms (µg) with incremental adjustment of 1 µg Receives: Drug: Paricalcitol |
| Paricalcitol 2 µg ± 2 µg | Experimental | Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg Receives: Drug: Paricalcitol |
| Paricalcitol 4 µg ± 1 µg | Experimental | Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg Receives: Drug: Paricalcitol |
| Paricalcitol 4 µg ± 2 µg | Experimental | Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg Receives: Drug: Paricalcitol |
| Maxacalcitol 5 or 10 µg ± 2.5 µg | Other | Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg Receives: Drug: Maxacalcitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With ≥ 50% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Serum Level
Measured: Baseline to Week 13 (Final Visit)
Secondary outcomes (5)
Mean Change From Baseline in Intact Parathyroid Hormone (iPTH) Level
Measured: Baseline to Week 13 (Final Visit)
Percentage of Subjects With Intact Parathyroid Hormone (iPTH) ≤ 180 Picograms/Milliliter (pg/mL)
Measured: Baseline to Week 13 (Final Visit)
Percentage of Subjects With 2 or More Decreases of ≥ 50% From Baseline in Intact Parathyroid Hormone (iPTH) Level
Measured: Through Week 13
Duration of 2 Consecutive Decreases of ≥ 50% From Baseline in Intact Parathyroid Hormone (iPTH) Values
Measured: Through Week 13
Duration of 2 Consecutive Intact Parathyroid Hormone (iPTH) Values ≤ 180 pg/mL
Measured: Through Week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionMar 2009
- Study completionMar 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 Chronic Kidney Disease on HemodialysisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abbott Japan Co.,Ltd
- Responsible party
- Sponsor
- Investigators
- Ryotaro Matsuzawa, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00667576
- Sponsor's protocol ID
- M10-309
- Status last verified
- Jan 2012
- First submitted
- 24 Apr 2008
- Last updated
- 20 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late Phase 2 Study of Paricalcitol Injection: Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism (Examination of Initial Dose and Incremental Dose)
- ClinicalTrials.gov ID
- NCT00667576
- Acronym / sponsor ID
- M10-309
- Keywords
- chronic kidney disease, secondary hyperparathyroidism, hemodialysis, paricalcitol, maxacalcitol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Collaborators
- Abbott Japan Co.,Ltd
- Study start
- Apr 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 28 Apr 2008 (estimated)
- Results
- Posted 2 Apr 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to investigate the initial dose and dose adjustment range for paricalcitol injection in patients with chronic kidney disease on hemodialysis who have secondary hyperparathyroidism.
Detailed description
This multicenter, randomized, open-label trial consisted of 4 dose-adjustment regimens for paricalcitol injection (initial doses and dose adjustment ranges were 2 ± 1 µg, 2 ± 2 µg, 4 ± 1 µg, and 4 ± 2 µg) and 1 maxacalcitol regimen (initial dose and dose adjustment range was 5 µg ± 2.5 µg or 10 µg ± 2.5 µg) as a reference group. Subjects who met the inclusion criteria were randomized equally to 1 of the treatment groups with iPTH values at screening (< 500 pg/mL or ≥ 500 pg/mL) as a dynamic allocation factor. Study drugs were administered 3 times weekly (every other day) from the venous end of the hemodialysis circuit just before completion of the dialysis session. The initial doses were continued for 2 weeks, followed by dose adjustments (increase, maintenance, decrease, suspension, or resumption) by 1 µg or 2 µg units for the paricalcitol groups and by 2.5 µg units for the maxacalcitol group based on iPTH, calcium (adjusted), and phosphorus values every 2 weeks.
Subjects in the paricalcitol groups were to be suspended from treatment if their iPTH value decreased to < 60 pg/mL in accordance with the guidelines proposed by the Japanese Society of Dialysis Therapy for the treatment of secondary hyperparathyroidism in chronic dialysis patients (control goal value of 60-180 pg/mL for iPTH). The dose adjustment criteria based on iPTH values for the maxacalcitol group were set according to the prescribing information for maxacalcitol (suspended when iPTH decreased to ≤ 150 pg/mL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Paricalcitol 2 µg ± 1 µg | Experimental | Drug: ParicalcitolParicalcitol initial dosage 2 micrograms (µg) with incremental adjustment of 1 µg |
| Paricalcitol 2 µg ± 2 µg | Experimental | Drug: ParicalcitolParicalcitol initial dosage 2 µg with incremental adjustment of 2 µg |
| Paricalcitol 4 µg ± 1 µg | Experimental | Drug: ParicalcitolParicalcitol initial dosage 4 µg with incremental adjustment of 1 µg |
| Paricalcitol 4 µg ± 2 µg | Experimental | Drug: ParicalcitolParicalcitol initial dosage 4 µg with incremental adjustment of 2 µg |
| Maxacalcitol 5 or 10 µg ± 2.5 µg | Other | Drug: MaxacalcitolMaxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with chronic kidney disease receiving hemodialysis 3 times a week for at least 3 months prior to obtaining the informed consent and scheduled to be receiving the same hemodialysis during the study period.
- Using dialysate with constant concentration of calcium for 4 weeks prior to obtaining informed consent and phosphate binder with constant dose regimen for 2 weeks prior to obtaining informed consent.
- Intact parathyroid hormone level (iPTH) ≥ 300 pg/mL
- Calcium (adjusted) 8.4-10.2 milligrams/deciliter (mg/dL)
- Phosphorus ≤ 6.5 mg/dL
Key exclusion criteria (7 listed)
- History of allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds
- Parathyroidectomy or ethanol infusion within past year
- Progressive malignancy or clinically significant hepatic diseases, severe cerebral/cardiovascular diseases, severe hypertension, or uncontrolled diabetes mellitus
- Drug or alcohol abuse within past 6 months
- Taking calcitonin, maintenance intravenous or oral glucocorticoids, cinacalcet, bisphosphonates, selective estrogen-receptor modulator (SERM), vitamin D compounds (other than study drug), or other drugs that may affect calcium or bone metabolism (other than estrogen or progestin, vitamin K2)
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 |
|---|---|---|
| MaxacalcitolStudy 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 12 weeks. | Drug | Maxacalcitol 5 or 10 µg ± 2.5 µg |
| ParicalcitolAlso: ABT-358, ZemplarStudy 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 12 weeks. | Drug | Paricalcitol 2 µg ± 1 µg, Paricalcitol 2 µg ± 2 µg, Paricalcitol 4 µg ± 1 µg, Paricalcitol 4 µg ± 2 µg |
Primary outcome
Percentage of Subjects With ≥ 50% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Serum Level
Time frame: Baseline to Week 13 (Final Visit)
5 secondary outcomes
Mean Change From Baseline in Intact Parathyroid Hormone (iPTH) Level
Time frame: Baseline to Week 13 (Final Visit)
Percentage of Subjects With Intact Parathyroid Hormone (iPTH) ≤ 180 Picograms/Milliliter (pg/mL)
Time frame: Baseline to Week 13 (Final Visit)
Percentage of Subjects With 2 or More Decreases of ≥ 50% From Baseline in Intact Parathyroid Hormone (iPTH) Level
Time frame: Through Week 13
Duration of 2 Consecutive Decreases of ≥ 50% From Baseline in Intact Parathyroid Hormone (iPTH) Values
Time frame: Through Week 13
Duration of 2 Consecutive Intact Parathyroid Hormone (iPTH) Values ≤ 180 pg/mL
Time frame: Through Week 13
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ryotaro Matsuzawa 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 Maxacalcitol and Paricalcitol in people with Chronic Kidney Disease on Hemodialysis and Secondary Hyperparathyroidism, 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 6 inclusion and 7 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 20 Jan 2012. 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 2 Apr 2010). 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 Subjects With ≥ 50% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Serum Level (time frame: Baseline to Week 13 (Final Visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2012.