Chronic Kidney Disease Patients on Hemodialysis With HyperphosphatemiaPhase 2NCT02753894

Dose Range-finding Study of ASP1585 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia

A Phase 2 study testing ASP1585 in people with Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia, run by Astellas Pharma Inc at 11 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 objective of this study is to examine the clinical dose range of ASP1585 based on the efficacy, safety, and feasibility of treatment in chronic kidney disease patients on hemodialysis with hyperphosphatemia. Read more about this study

Who is it for?: Ages 20 to 74 years
Conditions the study is for: Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia
What is being tested?: ASP1585
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 73 participants
Where: 11 sitesJapan
Study dates: Jan 2008to Jun 2008
Phase: Phase 2
Are there results?: None posted in the registry

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 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

For preliminary enrollment
Patients with stable chronic kidney disease who received hemodialysis 3 times a week for at least 12 weeks (84 days) prior to the day of preliminary enrollment
Patients who did not have dialysis conditions altered (dialysate calcium concentration, dialyser, and dry weight) within 10 days prior to the day of preliminary enrollment
Patients who did not have the following dosage or administration altered at least 28 days prior to the day of preliminary enrollment: phosphate binders, or drugs/food with phosphate binding action (including newly started treatment)
If receiving vitamin D or calcitonin agent, patients who did not have dosage and administration altered (including newly started treatment) for at least 28 days prior to the day of preliminary enrollment.
Patients who did not use cinacalcet hydrochloride for at least 28 days prior to the day of preliminary enrollment

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For practical enrollment
Patients whose pre-dialysis serum phosphorus level after the maximum dialysis interval at Week 1 of the washout period was ≥8.0 mg/dL and <10.0 mg/dL or that at Week 2 was ≥6.0 mg/dL and <10.0 mg/dL
Patients who continued to receive hemodialysis 3 times a week after the day of preliminary enrollment
Patients who did not have dialysis conditions altered (dialysate calcium concentration and dialyser) after the day of preliminary enrollment
Patients who did not receive phosphate binders, or drugs/food with phosphate binding action during the washout period
If receiving vitamin D or calcitonin agent (including start of new treatment) after the day of preliminary enrollment, patients who did not have dosage and administration altered for at least 28 days prior to the day of preliminary enrollment
Patients who did not use cinacalcet hydrochloride after the day of preliminary enrollment

Who cannot join

For preliminary enrollment
Patients with a history of gastrectomy or enterectomy (except for appendectomy) or with a complication of dysphagia, ileus, or hemorrhagic gastrointestinal lesions
Patients with severe persistent constipation or diarrhoea
Patients who underwent parathyroid intervention (parathyroidectomy [PTx], percutaneous ethanol injection therapy [PEIT], etc.) within 1 year prior to the day of preliminary enrollment
Patients who are fasted or are on extreme dietary restrictions
Patients with uncontrollable hypertension (all the last 3 measurement values of pre-dialysis systolic/diastolic blood pressure before the day of preliminary enrollment are ≥180 mmHg and ≥120 mmHg, respectively)

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Patients with severe heart disease (congestive heart failure [NYHA cardiac function classification Class III or severer], a history of extensive old myocardial infarction, etc.) or patients who were hospitalized for the treatment of cerebrovascular disease or heart disease within 12 weeks (84 days) prior to the day of preliminary enrollment
Patients with a complication of serious hepatic disease (acute and active chronic hepatitis, hepatic cirrhosis, etc.)
Patients with a history of serious drug hypersensitivity, such as anaphylactic shock
Patients with a history or complication of malignant tumor (considered eligible if recurrence has not been observed for at least 5 years)
Patients who are pregnant, nursing, suspected to be pregnant, or wish to become pregnant during the study period
Patients who have previously received ASP1585
Patients who participated in another clinical study or a post-marketing clinical study (including that of a medical device) within 12 weeks (84 days) prior to informed consent
For practical enrollment
Patients whose pre-dialysis serum phosphorus level after the maximum dialysis interval at Week 1 or 2 of the washout period was ≥10 mg/dL
Patients who underwent gastrectomy or enterectomy, or had dysphagia, ileus, or hemorrhagic gastrointestinal lesions after the day of preliminary enrollment
Patents who had severe persistent constipation or diarrhoea after the day of preliminary enrollment
Patients who underwent parathyroid intervention (parathyroidectomy [PTx], percutaneous ethanol injection therapy [PEIT], etc.) after the day of preliminary enrollment
Patients who were fasted or on extreme dietary restriction after the day of preliminary enrollment
Patients with uncontrollable hypertension (more than two thirds of pre-dialysis systolic/diastolic blood pressure values were ≥180 mmHg and ≥120 mmHg, respectively, after the day of preliminary enrollment)
Patients with severe heart disease (congestive heart failure [NYHA cardiac function classification Class III or severer], etc.) or patients who were hospitalized for the treatment of cerebrovascular disease or heart disease after the day of preliminary enrollment
Patients with a complication of impaired liver function (baseline AST or ALT was 100 IU/L or higher) or serious hepatic disease (acute and active chronic hepatitis, liver cirrhosis, etc.)
Patients who experienced serious drug hypersensitivity such as anaphylactic shock after the day of preliminary enrollment
Patients with a complication of malignant tumor
Patients who were found to be pregnant after the day of preliminary enrollment
Patients who participated in another clinical study or a post-marketing clinical study (including that of a medical device) after the day of informed consent

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

Japan11 sites

Site JP00009
Chiba, Chiba
Site JP00010
Chiba, Chiba
Site JP00006
Ibaraki, Ibaraki
Site JP00007
Ibaraki, Ibaraki
Site JP00008
Ibaraki, Ibaraki
Site JP00001
Miyagi, Miyagi
Site JP00002
Miyagi, Miyagi
Site JP00003
Nagano, Nagano
Site JP00004
Nagano, Nagano
Site JP00005
Nagano, Nagano
Site JP00011
Okazaki, Aichi-ken

Other trials in Japan

About this study

Official title: Phase II Dose Range-finding Study of ASP1585 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia

Conditions: Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia
Being tested: ASP1585
Keywords: Dose-finding, Hemodialysis, ASP1585, Chronic kidney disease
Medical subject headings: Renal Insufficiency, Chronic

What participants receive

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

ASP1585Drug
Also called Bixalomer, Kiklin (R)
Oral

Study groups in NCT02753894
Study group	Role	What they receive
4.5 g/day group	Experimental	Three times a day Receives: Drug: ASP1585
6.0 g/day group	Experimental	Three times a day Receives: Drug: ASP1585
7.5 g/day group	Experimental	Three times a day Receives: Drug: ASP1585

What is being measured

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

Change from the baseline of serum phosphorus level
Measured: Baseline and Week 6
Safety assessed by AEs
Measured: Up to 6 weeks after the study drug dosing
Safety assessed by Hematology test
Measured: Up to 6 weeks after the study drug dosing
Safety assessed by Blood biochemistry tests
Measured: Up to 6 weeks after the study drug dosing
Safety assessed by Blood cogulability tests
Measured: Up to 6 weeks after the study drug dosing
Blood concentration of Vitamin
Measured: Up to 6 weeks after the study drug dosing
Safety assessed by Vital signs
Systolic blood pressure, diastolic blood pressure, heart rate
Measured: Up to 6 weeks after the study drug dosing
Safety assessed by bowel movement
Measured: Up to 6 weeks after the study drug dosing
Safety assessed by ECG
Measured: Up to 6 weeks after the study drug dosing

Secondary outcomes (6)

Time course of serum phosphorus level
Measured: Up to Week 6
Time course of corrected serum calcium level
Measured: Up to Week 6
Time course of calcium-phosphorus product
Measured: Up to Week 6
Time course of intact parathyroid hormone
Measured: Up to Week 6
Percentage of subjects who achieved the target serum phosphorus level (3.5 to 6.0 mg/dL)
Measured: Up to Week 6
Time achievement of the target serum phosphorus level (3.5 to 6.0 mg/dL)
Measured: Up to Week 6

Timeline

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

Jan 2008Jun 2008

First posted28 Apr 2016 (estimated)
Study startJan 2008
Primary completionJun 2008
Study completionJun 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Kidney Disease Patients on Hemodialysis With HyperphosphatemiaStudies 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: 73 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02753894
Sponsor's protocol ID: 1585-CL-0006
Status last verified: Apr 2016
First submitted: 3 Mar 2016
Last updated: 21 Jun 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Dose Range-finding Study of ASP1585 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia
ClinicalTrials.gov ID: NCT02753894
Acronym / sponsor ID: 1585-CL-0006
Conditions: Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia
Keywords: Dose-finding, Hemodialysis, ASP1585, Chronic kidney disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 73 participants (actual)
Lead sponsor: Astellas Pharma IncIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 28 Apr 2016 (estimated)
Results: Not posted in the source record

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
4.5 g/day group	Experimental	Drug: ASP1585Three times a day
6.0 g/day group	Experimental	Drug: ASP1585Three times a day
7.5 g/day group	Experimental	Drug: ASP1585Three times a day

Who may qualify

Ages: 20 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

For preliminary enrollment
Patients with stable chronic kidney disease who received hemodialysis 3 times a week for at least 12 weeks (84 days) prior to the day of preliminary enrollment
Patients who did not have dialysis conditions altered (dialysate calcium concentration, dialyser, and dry weight) within 10 days prior to the day of preliminary enrollment
Patients who did not have the following dosage or administration altered at least 28 days prior to the day of preliminary enrollment: phosphate binders, or drugs/food with phosphate binding action (including newly started treatment)
If receiving vitamin D or calcitonin agent, patients who did not have dosage and administration altered (including newly started treatment) for at least 28 days prior to the day of preliminary enrollment.

Key exclusion criteria (26 listed)

For preliminary enrollment
Patients with a history of gastrectomy or enterectomy (except for appendectomy) or with a complication of dysphagia, ileus, or hemorrhagic gastrointestinal lesions
Patients with severe persistent constipation or diarrhoea
Patients who underwent parathyroid intervention (parathyroidectomy [PTx], percutaneous ethanol injection therapy [PEIT], etc.) within 1 year prior to the day of preliminary enrollment
Patients who are fasted or are on extreme dietary restrictions

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
ASP1585Also: Bixalomer, Kiklin (R)Oral	Drug	4.5 g/day group, 6.0 g/day group, 7.5 g/day group

Primary outcome

Change from the baseline of serum phosphorus level
Time frame: Baseline and Week 6
Safety assessed by AEs
Time frame: Up to 6 weeks after the study drug dosing
Safety assessed by Hematology test
Time frame: Up to 6 weeks after the study drug dosing
Safety assessed by Blood biochemistry tests
Time frame: Up to 6 weeks after the study drug dosing
Safety assessed by Blood cogulability tests
Time frame: Up to 6 weeks after the study drug dosing
Blood concentration of Vitamin
Time frame: Up to 6 weeks after the study drug dosing
Safety assessed by Vital signs
Time frame: Up to 6 weeks after the study drug dosing
Systolic blood pressure, diastolic blood pressure, heart rate
Safety assessed by bowel movement
Time frame: Up to 6 weeks after the study drug dosing
Safety assessed by ECG
Time frame: Up to 6 weeks after the study drug dosing

6 secondary outcomes

Time course of serum phosphorus level
Time frame: Up to Week 6
Time course of corrected serum calcium level
Time frame: Up to Week 6
Time course of calcium-phosphorus product
Time frame: Up to Week 6
Time course of intact parathyroid hormone
Time frame: Up to Week 6
Percentage of subjects who achieved the target serum phosphorus level (3.5 to 6.0 mg/dL)
Time frame: Up to Week 6
Time achievement of the target serum phosphorus level (3.5 to 6.0 mg/dL)
Time frame: Up to Week 6

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
Individual participant dataSharing planned: Undecided

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.

Medical Director study director

Astellas Pharma Inc

11 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 ASP1585 in people with Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia, run by Astellas Pharma Inc at 11 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 13 inclusion and 26 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 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from the baseline of serum phosphorus level (time frame: Baseline and Week 6). The study lists 9 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 NCT02753894.

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 21 Jun 2016; AzTrials last refreshed its copy on 7 Nov 2026.